Version 3.1.1 (Final)
Prepared by the
CDISC Standard for Exchange of Nonclinical Data Team
Notes to Readers
This implementation guide for nonclinical studies is based upon Version 1.5 of the CDISC Study Data Tabulation Model (SDTM).
Date | Version |
2021-03-30 | 3.1.1 Final |
2016-06-27 | 3.1 Final |
2011-04-30 | 3.0 Final |
See Appendix F for Representations and Warranties, Limitations of Liability, and Disclaimers
USING SEND IN THE CONTEXT OF A DATA EXCHANGE PACKAGE
General Variable Assumptions 22
Coding and Controlled Terminology Assumptions 26
MODELS FOR SPECIAL-PURPOSE DOMAINS
DOMAIN MODELS BASED ON THE GENERAL OBSERVATION CLASSES
REPRESENTING RELATIONSHIPS AND DATA
Appendix A: CDISC SEND Team 234
Appendix B: Glossary and Abbreviations 236
Appendix C: Mapping To tumor.xpt File 237
Appendix D: Revision History 241
APPENDIX E: SDTM VARIABLES TO NEVER USE IN SEND 242
Appendix F: Representations and Warranties, Limitations of Liability, and Disclaimers 244
This document is the Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG) for nonclinical studies, which has been prepared by the CDISC SEND Team. The SENDIG is intended to guide the organization, structure, and format of standard nonclinical tabulation datasets for interchange between organizations such as sponsors and contract research organizations (CROs), and for submission to regulatory authorities such as the US Food and Drug Administration (FDA).
The SENDIG is based upon and should be used in close concert with Version 1.5 of the CDISC Study Data Tabulation Model (SDTM), available at https://www.cdisc.org/standards/foundational/sdtm. The SDTM describes the conceptual model for representing study data for electronic data interchange and should be read prior to reading the SENDIG. The SENDIG provides specific domain models, assumptions, business rules, and examples for preparing standard nonclinical tabulation datasets that are based on the SDTM. This version of the SENDIG is designed to support data typically found in single-dose general toxicology, repeat-dose general toxicology, and carcinogenicity studies, as well as respiratory and cardiovascular testing done during safety pharmacology studies. The SENDIG can be used to represent data for other study types. Note that SEND is an exchange standard, rather than a presentation format; it is assumed that tabulation data will be transformed by software tools to better support viewing and analysis.
Conformance with the guidelines in this document does not guarantee that data can support all types of analysis. Science and regulation should determine what data should be collected and how. The analyses that the data need to support should be accounted for before mapping the data into the exchange format.
Because the FDA has been the leading regulator in encouraging the development of SEND, this document references some specific implementation requirements for that agency. The CDISC SEND Team welcomes input from other regulatory agencies so that future versions of the SENDIG can be maximally useful in all regions. SEND is expected to be referenced by the FDA in guidance documents, and audiences are advised to refer to these guidance documents for the most current agency recommendations for the submission of nonclinical data.
Standardized datasets are expected to support (1) the FDA's efforts to develop a repository for all submitted study data, and (2) a suite of standard review tools to access, query, and view the tabulations.
Organization of this Document
This document is organized into the following sections:
Section 1, Introduction, provides an overall introduction to the SENDIG.
Section 2, Fundamentals of the SDTM, recaps the basic concepts of the SDTM and describes how this implementation guide should be used in concert with the SDTM.
Section 3, Using SEND in the Context of a Data Exchange Package, explains how to describe metadata and how to assess conformance with the standards.
Section 4, Assumptions for Domain Models, describes basic concepts, business rules, and assumptions that should be taken into consideration before applying the domain models.
Section 5, Models for Special-purpose Domains, describes special-purpose domains.
Section 6, Domain Models Based on the General Observation Classes, provides specific metadata models based on the 3 general observation classes, along with assumptions and example data.
Section 7, Trial Design Model Datasets, describes implementation recommendations related to the use of the Trial Design Model described in the SDTM.
Section 8, Representing Relationships and Data, describes how to represent relationships between separate domains, datasets, and/or records and information to help sponsors determine where data belong in the SDTM. Section 8.5 describes how to represent data from samples or subjects that have been pooled.
Appendices provide additional background material and describe other supplemental material relevant to implementation.
Relationship to Prior CDISC Documents
The changes to the SENDIG since the prior version (v3.1) are limited to the Pharmacokinetics Concentrations (PC) and Pharmacokinetics Parameters (PP) domains, assumptions, and examples. These changes are intended to instruct the reader on the approach to populating PC and PP variables to create the time/concentration curve and to present well-formed examples of PC, PP, and cross-domain examples.
A detailed list of all changes between SENDIG versions is provided in Appendix D, Revision History.
A list of approved SDTM variables that should not be used in SEND datasets is provided in Appendix E, SDTM Variables to Never Use in SEND.
How to Read this Implementation Guide
The SENDIG is best read online so the reader can more easily navigate the many hyperlinks to internal and external references. Note that for the purposes of modeling nonclinical data using the SENDIG, the term "subject" is equivalent to an animal; the term "trial" is equivalent to a study, and "interventions" generally refers to exposure to drug.
The following guidelines may be helpful in reading this document.
First, read the SDTM to gain a general understanding of SDTM concepts.
Next, read Sections 1-3 (Introduction, Fundamentals of the SDTM, and Using SEND in the Context of a Data Exchange Package) of this document to review the key concepts for preparing domains and submitting data to regulatory authorities. Refer to Appendix B, Glossary and Abbreviations, as necessary.
Read Section 4, Assumptions for Domain Models.
Review Sections 5 and 6 (Models for Special-purpose Domains and Domain Models Based on the General Observation Classes) in detail, referring back to Section 4 as directed (hyperlinks are provided).
Read Section 7, Trial Design Model Datasets, to understand the fundamentals of the Trial Design Model datasets and consider how to apply the concepts for typical protocols.
Review Section 8, Representing Relationships and Data, to learn advanced concepts regarding how to express relationships between datasets and records, adding variables not specifically defined in the models, and representing single findings captured for multiple subjects.
Review SEND Controlled Terminology (CT) available on the CDISC website at: http://www.cdisc.org/terminology.
Finally, review the Appendices as appropriate.
The General Observation Classes
Most subject-level observations collected during the study should be represented according to 1 of the 3 SDTM general observation classes: Interventions, Events, or Findings. The lists of variables allowed to be used in each of these can be found in the SDTM.
The Interventions class captures investigational, therapeutic, and other treatments that are administered to the subject (with some actual or expected physiological effect) as specified by the study protocol (e.g., exposure to study drug).
The Events class captures subject disposition.
The Findings class captures the observations resulting from tests or evaluations (e.g., laboratory tests, body weights, food and water consumption, clinical observations). Most data consist of measurements or responses to tests conducted at specified intervals and will fit the Findings general observation class.
SENDIG domains are based upon the SDTM and include variables relevant to model common endpoints in nonclinical studies. Use of SDTM variables must be consistent with the description of the variables in the SDTM. In most cases, the choice of general observation class appropriate to a specific collection of data can be determined according to the preceding descriptions.
All datasets based on any of the general observation classes share a common set of identifier variables and timing variables. Three general rules apply when determining which variables to include in a domain:
The same set of identifier variables apply to all general observation classes.
Any timing variables are permissible for use in any submission dataset based on a general observation class, except for those variables not intended for use with SEND (see Appendix E, SDTM Variables to Never Use in SEND).
Any additional qualifier variables from the same general observation class may be added to a domain model, except for those variables not intended for use with SEND (see Appendix E, SDTM Variables to Never Use in SEND).
General assumptions for use with all domain models based on the general observation classes are described in Section 4, Assumptions for Domain Models; specific assumptions for individual domains are included with the domain model.
In addition to the general observation classes, a submission will generally include a set of other special-purpose datasets of specific standardized structures to represent additional information. The SDTM includes 3 types of special-purpose datasets, each of which has a fixed structure:
Demographics (DM), Comments (CO), and Subject Elements (SE) include study data that do not conform to 1 of the 3 general observation classes. These are described in Section 5, Models for Special-purpose Domains.
Trial Design Model datasets, consisting of Trial Elements (TE), Trial Arms (TA), Trial Sets (TX), and Trial Summary (TS), contain information about the study design but do not contain subject data. These are described in Section 7, Trial Design Model Datasets.
RELREC, SUPP--, and POOLDEF are relationship datasets. These are described in Section 8, Representing Relationships and Data.
The SENDIG Standard Domain Models
The following standard domains with their respective domain codes are included in this document.
Special-Purpose Domains (Section 5)
Demographics – DM
Comments – CO
Subject Elements – SE
Interventions General Observation Class (Section 6.1)
Exposure – EX
Events General Observation Class (Section 6.2)
Disposition – DS
Findings General Observation Class (Section 6.3)
Body Weight – BW
Body Weight Gain – BG
Clinical Observations – CL
Death Diagnosis and Details – DD
Food and Water Consumption – FW
Laboratory Test Results – LB
Macroscopic Findings – MA
Microscopic Findings – MI
Organ Measurements – OM
Palpable Masses – PM
Pharmacokinetics Concentrations – PC
Pharmacokinetics Parameters – PP
Subject Characteristics – SC
Tumor Findings – TF
Vital Signs – VS
ECG Test Results – EG
Cardiovascular Test Results – CV
Respiratory Test Results – RE
Trial Design Domains (Section 7)
Trial Elements – TE
Trial Arms – TA
Trial Sets – TX
Trial Summary – TS
Relationship Datasets (Section 8)
Related Records – RELREC
Supplemental Qualifiers – SUPP-- datasets
Pool Definition – POOLDEF
A sponsor should submit only domain datasets for which data were actually collected (or directly derived from the collected data) for a given study. Decisions on what data to collect should be based on the scientific objectives of the study, rather than domains or examples presented in this guide. Although most studies will include DM, TX, TS, and
a set of domains based on the 3 general observation classes, the actual domains used to represent study data will depend upon the needs of the recipient.
When preparing datasets based on SENDIG domain models, sponsors must not add any variables other than specified identifier variables (See SDTM v1.5 Table 2.2.4), timing variables (SDTM v1.5 Table 2.2.5), or qualifier variables from the same general observation class (described in SDTM v1.5 Tables 2.2.1-2.2.3). The addition of non-standard variables will compromise the ability to use the datasets (e.g., to populate a data repository and/or use standard tools). See Appendix E, SDTM Variables to Never Use in SEND, for a list of SDTM variables that should never be used in SEND.
As long as there are no data that can be mapped to a permissible variable, a sponsor may exclude the variable from a domain dataset, and the corresponding descriptions from the data definition file. New variables (other than those from the same general observation class) must not be added, and existing variables must not be renamed or modified for novel usage.
The SDTM allows for the inclusion of the sponsor's non-SDTM variables using the Supplemental Qualifiers dataset structure, described in Section 8.3, Supplemental Qualifiers - SUPP-- Datasets. As the SDTM continues to evolve, certain additional standard variables may be added to the general observation classes. Sponsors wishing to nominate such variables for future consideration should provide a rationale and description of the proposed variable(s), along with representative examples, to the CDISC SEND Team via the CDISC website (https://www.cdisc.org/contact).
The SDTM is built around the concept of observations collected about subjects included in a study. The SENDIG is based on the SDTM general framework for organizing nonclinical study information that is to be transferred between parties or submitted to regulatory authorities.
Each observation is described by a series of variables corresponding to a row in a dataset or table. Each variable can be classified according to its role. A role determines the type of information conveyed by the variable about each distinct observation and how it can be used. Variables can be classified into 5 major roles:
-TEST, which is an equivalent term for a --TESTCD.
--ORNRLO, all of which are variable qualifiers of --ORRES, and --DOSU, which is a variable qualifier of -
-DOSE.
The creation of new domains is an ongoing activity of both the CDISC Submission Data Standards (SDS) and SEND teams. Before creating a new domain or attempting to represent data in a sponsor-defined domain, check with these teams to see if implementation guidance for this type of data exists or is being developed. Even though domains not described in this SENDIG may not be able to be evaluated for conformance with this standard, all domains must conform to the principles in the SDTM.
Using SEND in the Context of a Data Exchange Package
Test results, examinations, and observations for subjects in a nonclinical study are represented in a series of SEND domains. A domain is defined as a collection of logically related observations with a common topic. The logic of the relationship may pertain to the scientific subject matter of the data or to its role in the study. Typically, each domain is represented by a single dataset.
When determining which general-observation class domain model is appropriate for reporting specific observations, refer to the domain definition included in the Assumptions section for each domain model (see Section 6, Domain Models Based on the General Observation Classes). For Findings domains that have a controlled terminology codelist associated with the --TESTCD and --TEST variables, a review of that codelist also provides guidance.
Although the domain name is carefully selected, it is the structures and specifications within the domain that drive placement of data. It is important to note that the domain structure is only used for organizational purposes. The -- TEST and --METHOD variable entries in the domain contribute to the identification of the test performed and the conditions under which the test was performed; the domain name or organization is not intended to imply any of this information.
Each domain dataset is distinguished by a unique 2-character code that should be used consistently throughout the submission. This code, which is represented in the SDTM variable named DOMAIN, is used in 4 ways: as the dataset name, as the value of the DOMAIN variable in that dataset, as a prefix for most variable names in that dataset, and as a value in the RDOMAIN variable in relationship tables (see Section 8, Representing Relationships and Data).
All datasets are structured as flat files with rows representing observations and columns representing variables.
Domain Model Variable-level Metadata
The specification of each domain in this guide begins with a table describing the domain's variables (a row for each) and their associated attributes (the columns across).
The following are the attributes (columns) used in this guide to describe each domain's variables:
The Variable Name column specifies the name of the variable; in other words, the name of the column of the dataset (e.g., "STUDYID").
The Variable Label column specifies a descriptive label for the variable (e.g., "Study Identifier").
The Type column specifies the data type of the variable. This must be "Num" for numeric data and "Char" for character (or alphanumeric) data.
The Controlled Terms, Codelist, or Format column specifies any controlled terminology or formats that apply to the variable. Controlled lists are surrounded with parentheses (e.g., "(BWTESTCD)" for the BWTESTCD Controlled Terminology Codelist). When a fixed value (e.g., the value for the DOMAIN variable) applies, the available value will be displayed (e.g., "BW"). When a format applies, the name of the format will be displayed (e.g., "ISO 8601" for the ISO 8601 date format).
The Role column specifies the role of the variable (see Section 2.4, Observations and Variables).
The CDISC Notes column specifies details about the proper use of the variable (e.g., description of the variable's purpose, intended use, rules governing its population, example values).
The Core column specifies whether the variable is "Req" (required), "Exp" (expected), or "Perm" (permissible); (see Section 4.1.3, Core Variables).
A data definition file (see the Define-XML specification, available at https://www.cdisc.org/standards/data- exchange/define-xml) is expected to accompany any transfer of SEND datasets, so that the contents of the datasets are understood. In addition, a data definition file should accompany each study in a submission, according to the FDA Study Data Technical Conformance Guide (https://www.fda.gov/media/143550/download).
The data definition file that accompanies any data exchange package should describe each dataset included in the submission and describe each dataset's natural key structure. Dataset definition metadata should include dataset filenames, descriptions, class, structure, purpose, keys, and location, as shown in Table 3.2.1.
In the event that no records are present in a dataset, the empty dataset should not be submitted and should not be described in the data definition file.
The Define-XML specification includes 7 distinct attributes to describe dataset-level metadata:
Dataset — the file name of the dataset or data domain name (e.g., "dm.xpt," "DM")
Description — a short description of the type of information contained within the dataset (e.g., "Demographics," "Laboratory Test Results")
Class — Intervention, Events, Findings, or Relationship domain
Structure — the level of detail represented by individual records in the dataset (e.g., "One record per subject," "One record per subject per visit," "One record per subject per event")
Purpose — purpose for the dataset (e.g., "Tabulation," "Analysis")
Keys (see also Section 3.2.1.1, Keys) — used to uniquely identify and index each record in a dataset; could function as foreign keys to facilitate linking to other datasets. Most datasets will have 2-5 key variables. Table 3.2.1 shows examples of the variables a sponsor might submit as natural keys for the datasets.
Location — folder and filename where the dataset can be found See the Define-XML specification for terms and exact case to be used.
Dataset | Description | Class | Structure | Purpose | Keys | Location |
DM | Demographics | Special-Purpose Domain | One record per subject | Tabulation | STUDYID, USUBJID | dm.xpt |
CO | Comments | Special-Purpose Domain | One record per comment | Tabulation | STUDYID, COSEQ | co.xpt |
SE | Subject Elements | Special-Purpose Domain | One record per element experienced per subject | Tabulation | STUDYID, USUBJID, ETCD, SESTDTC | se.xpt |
EX | Exposure | Interventions | One record per constant dosing interval per treatment per subject or pool | Tabulation | STUDYID, USUBJID or POOLID, EXTRT, EXSTDTC | ex.xpt |
DS | Disposition | Events | One record per subject | Tabulation | STUDYID, USUBJID | ds.xpt |
BW | Body Weights | Findings | One record per test per observation time per subject | Tabulation | STUDYID, USUBJID, BWTESTCD, BWDTC | bw.xpt |
BG | Body Weight Gains | Findings | One record per test per interval per subject | Tabulation | STUDYID, USUBJID, BGTESTCD, BGDTC, BGENDTC | bg.xpt |
CL | Clinical Observations | Findings | One record per finding per observation time per subject or pool | Tabulation | STUDYID, USUBJID or POOLID, CLTESTCD, CLCAT, CLORRES, CLLOC, CLDTC | cl.xpt |
CV | Cardiovascular | Findings | One record per test per observation time or evaluation interval per subject | Tabulation | STUDYID, USUBJID, CVTESTCD, CVTPTREF, CVTPTNUM | cv.xpt |
DD | Death Diagnosis and Details | Findings | One record per diagnosis per subject (for unscheduled deaths only) | Tabulation | STUDYID, USUBJID, DDORRES | dd.xpt |
EG | ECG | Findings | One record per test per observation time per subject | Tabulation | STUDYID, USUBJID, EGTESTCD, EGTPTREF, EGTPTNUM | eg.xpt |
FW | Food and Water Consumption | Findings | One record per test per interval per subject or pool | Tabulation | STUDYID, USUBJID or POOLID, FWTESTCD, FWDTC, FWENDTC | fw.xpt |
LB | Laboratory | Findings | One record per test per specimen per observation time per subject or pool | Tabulation | STUDYID, USUBJID or POOLID, LBTESTCD, LBSPEC, LBDTC, LBTPTNUM | lb.xpt |
MA | Macroscopic Findings | Findings | One record per finding per specimen per subject | Tabulation | STUDYID, USUBJID, MATESTCD, MAORRES, MASPEC, MAANTREG, MALAT, MADIR | ma.xpt |
MI | Microscopic Findings | Findings | One record per finding per specimen per subject | Tabulation | STUDYID, USUBJID, MITESTCD, MISTRESC, MISPEC, MIANTREG, MILAT, MIDIR | mi.xpt |
OM | Organ Measurements | Findings | One record per test per specimen per subject | Tabulation | STUDYID, USUBJID, OMTESTCD, OMSPEC, OMANTREG, OMLAT, OMDIR | om.xpt |
PM | Palpable Masses | Findings | One record per test per palpable mass per observation time per subject | Tabulation | STUDYID, USUBJID, PMTESTCD, PMSPID, PMDTC | pm.xpt |
PC | Pharmacokinetics Concentrations | Findings | One record per test per specimen per observation time per subject or pool | Tabulation | STUDYID, USUBJID or POOLID, PCTESTCD, PCSPEC, PCNOMDY, PCELTM, PCTPTREF | pc.xpt |
PP | Pharmacokinetics Parameters | Findings | One record per Pharmacokinetic Parameter per time-concentration profile per specimen per subject or pool | Tabulation | STUDYID, USUBJID or POOLID, PPTESTCD, PPCAT, PPSPEC, PPNOMDY, PPTPTREF | pp.xpt |
RE | Respiratory Test Results | Findings | One record per test per observation time or evaluation interval per subject | Tabulation | STUDYID, USUBJID, RETESTCD, REDTC, RETPT | re.xpt |
SC | Subject Characteristics | Findings | One record per characteristic per subject | Tabulation | STUDYID, USUBJID, SCTESTCD | sc.xpt |
TF | Tumor Findings | Findings | One record per tumor per specimen per subject | Tabulation | STUDYID, USUBJID, TFTESTCD, TFORRES, TFSPEC, TFANTREG, TFLAT, TFDIR | tf.xpt |
VS | Vital Signs | Findings | One record per measurement per observation time per subject | Tabulation | STUDYID, USUBJID, VSTESTCD, VSDTC, VSTPT | vs.xpt |
TE | Trial Elements | Trial Design | One record per planned Element | Tabulation | STUDYID, ETCD | te.xpt |
TA | Trial Arms | Trial Design | One record per planned Element per Arm | Tabulation | STUDYID, ARMCD, TAETORD | ta.xpt |
TX | Trial Sets | Trial Design | One record per Trial Set parameter per Trial Set | Tabulation | STUDYID, SETCD, TXPARMCD | tx.xpt |
Dataset | Description | Class | Structure | Purpose | Keys | Location |
TS | Trial Summary | Trial Design | One record per Trial Summary parameter value | Tabulation | STUDYID, TSPARMCD, TSSEQ | ts.xpt |
POOLDEF | Pool Definition | Relationship Datasets | One record per subject per pool | Tabulation | STUDYID, USUBJID, POOLID | pooldef.xpt |
RELREC | Related Records | Relationship Datasets | One record per related record, related group of records (e.g.,--GRPID), or related dataset | Tabulation | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, RELID | relrec.xpt |
SUPP-- | Supplemental Qualifiers for (domain name) | Relationship Datasets | One record per IDVAR, IDVARVAL, and QNAM value per subject per related domain | Tabulation | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | supp--.xpt |
Because the purpose of the Keys column is to aid reviewers in understanding the structure of a dataset, sponsors should list all of the variables that comprise the natural key for each dataset. This key should define uniqueness for records within the corresponding dataset, and may define a record sort order. The naming of these keys should be consistent with the description of the structure in the Structure column.
Primary Keys
A primary key is a set of 1 or more columns of a domain that uniquely defines each record and distinguishes it from any other record in the dataset. For all the general-observation class domains (and for some special-purpose domains), the --SEQ variable was created so that a unique record could be identified consistently across all of these domains using STUDYID, USUBJID or POOLID, DOMAIN, and --SEQ. In most domains, --SEQ will be a surrogate key for a set of variables that comprise the natural key.
Primary keys can be surrogate keys or natural keys.
Surrogate Keys
A surrogate key is a single-part, artificially established identifier for a record. Surrogate key assignment is a special case of derived data, one where a portion of the primary key is derived. A surrogate key is immune to changes in business needs. A common way of deriving surrogate key values is to assign integer values sequentially. The --SEQ in the SDTM datasets is an example of a surrogate key.
Natural Keys
Natural keys are variables that exist in the data. The advantage of natural keys is that they exist already, precluding the introduction of a new, unnatural value to the data schema. One of the difficulties in choosing a natural key is that just about any natural key has the potential to change. Because they have business meaning, natural keys are effectively coupled to the business, and they may need to be reworked when business requirements change.[1] An example of such a change in nonclinical study data would be the addition of a position or location that becomes a key in a new study, but was not collected in previous studies.
The following examples illustrate how to specify natural keys and include a case where a supplemental qualifier variable is referenced because it forms part of the natural key.
This is an example of a Clinical Observations (CL) domain for physical examinations.
Sponsor A chooses the following natural key for the CL domain:
STUDYID, USUBJID, CLTESTCD, CLDY, CLTPT
Sponsor B collects data in such a way that the location (CLLOC) variable needs to be included in the natural key to identify a unique row, and the observation date (CLDTC) confers uniqueness. Sponsor B then defines the following natural key for the CL domain.
STUDYID, USUBJID, CLTESTCD, CLLOC, CLDTC
In certain instances, a supplemental qualifier (SUPP--) variable might also contribute to the natural key of a record for a particular domain, and therefore need to be referenced as part of the natural key for a domain. Note that a domain is not limited by physical structure. A domain may consist of more than 1 physical dataset (e.g., the main domain dataset and its associated supplemental qualifiers dataset; see Section 8.3, Supplemental Qualifiers - SUPP-- Datasets). Supplemental qualifiers variables should be referenced in the natural key by using a 2-part name. The term QNAM must be used as the first part of the name to indicate that the contributing variable exists in a domain- specific SUPP-- dataset. The second part is the value of QNAM that ultimately becomes a column reference when the SUPP-- records are added to the main domain dataset (e.g., QNAM.XVAR, when the SUPP-- record has a QNAM of "XVAR").
Continuing with the CL domain example:
Sponsor B might have used ultrasound as a method of measurement and might have collected additional information such as the makes and models of ultrasound equipment employed. The sponsor considers the make and model information to be essential data that contributes to the uniqueness of the test result, and so creates supplemental qualifier variables for make (QNAM = CLMAKE) and model (QNAM = CLMODEL). The natural key is then defined as follows:
STUDYID, USUBJID, CLTESTCD, CLLOC, CLDTC, QNAM.CLMAKE, QNAM.CLMODEL
This approach becomes very useful in a Findings domain when a sponsor might choose to employ generic -- TESTCD values rather than compound --TESTCD values. The use of generic test codes helps to create distinct lists of manageable controlled terminology for --TESTCD.
In studies where multiple repetitive tests or measurements are being made (e.g., in an arthritis study where repetitive measurements of bone erosion in the leg might be made using both x-ray and MRI equipment) one approach to recording this data might be to create an individual --TESTCD value for each measurement.
Taking just the phalanges, a sponsor might need to express the following in a test code in order to make it unique:
Left or right leg
Phalange position (proximal/distal/middle)
Rotation of the leg
Method of measurement (x-ray/MRI)
Machine make
Machine model
Trying to encapsulate all of this information within a unique value of a --TESTCD is not a recommended approach for the following reasons:
It results in the creation of a potentially large number of test codes.
The 8-character values of --TESTCD become less intuitively meaningful.
Multiple test codes essentially represent the same test or measurement simply to accommodate attributes of a test within the --TESTCD value itself (e.g., to represent a body location at which a measurement was taken).
As a result, the preferred approach is to use a generic (or simple) test code that requires associated qualifier variables to fully express the test detail. Using this approach in the preceding example:
A generic --TESTCD value might be "EROSION" and the additional components of the compound test codes would be represented in a number of distinct qualifier variables. These may include domain variables (--LOC, etc.) and supplemental qualifier variables (QNAM.MAKE, QNAM.MODEL, etc.). Expressing the natural key becomes very important in this situation in order to communicate the variables that contribute to the uniqueness of a test.
If a generic --TESTCD were used the following variables would be used to fully describe the test conducted: the test is "EROSION", the location is "LEFT MCP I", the method of measurement is "ULTRASOUND", the make of the ultrasound machine is "ACME", and the model of the ultrasound machine is "U 2.1." This domain includes both domain variables and supplemental qualifier variables that contribute to the natural key of each row and describe the uniqueness of the test.
--TESTCD | --TEST | --LOC | --METHOD | QNAM.MAKE | QNAM.MODEL |
EROSION | Erosion | LEFT MCP I | ULTRASOUND | ACME | U 2.1 |
1. Choose your wow! Agile Requirements Change Management. Updated 2005-2021. Accessed March 23, 2021. http://www.agilemodeling.com/essays/changeManagement.htm
Each dataset is described by metadata definitions that provide information about the variables used in the dataset. The Define-XML specification includes 7 distinct attributes to describe variable-level metadata:
The variable name (limited to 8 characters for compatibility with the SAS v5 transport file format)
A descriptive variable label, using up to 40 characters, which should be unique for each variable in the dataset
The data type (e.g. whether the variable value is a character or numeric)
The set of controlled terminology for the value or the presentation format of the variable
(controlled term, codelist, or format); see Section 4.3, Coding and Controlled Terminology Assumptions
The origin of each variable 9e.g., whether it was collected or derived)
The role of the variable, which determines how the variable is used in the dataset. For SEND domain models, roles are used to represent the categories of variables (e.g., identifier, topic, timing; the 5 types of qualifiers).
Comments or other relevant information included by the sponsor as necessary to communicate information about the variable or its value content. Comments are not to be used just to copy the CDISC Notes.
The domain models in Section 6, Domain Models Based on the General Observation Classes, illustrate how to apply the SDTM to create SEND-conforming datasets. In particular, each model illustrates the selection of a subset of the variables offered in one of the general-observation classes, along with the applicable identifier and timing variables. The models also show how a standard variable from a general observation class should be adjusted to meet the specific content needs of a particular domain, including specifying controlled terminology and creating domain- specific notes and examples. Thus, the domain models demonstrate not only how to apply the model for the most common domains, but also give insight on how to apply general model concepts to other domains not yet defined by CDISC.
The Origin column of the data definition file is used to indicate where the data originated. Its purpose is to unambiguously communicate to the reviewer whether the data were collected, derived (and thus traceable to some derivation algorithm), or assigned by some subjective process (and thus traceable to some external evaluator).
The Define-XML specification lists allowable values for describing the origin metadata. The SENDIG defines the following controlled terms for specifying origin:
COLLECTED | A designation of "COLLECTED" means that the data were collected via manual or electronic means in a nonclinical study setting. This term should be used for data that were actually observed or recorded by a person or received from an instrument; it should not be used for data that have been calculated, interpreted, or derived from other information. |
DERIVED | "DERIVED" is assigned to values that were not directly collected, but were calculated by an algorithm or reproducible rule, which was dependent upon other data values. The derivation is assumed to be performed by the producer of the dataset. This does not apply to derived lab test results performed directly by laboratories (or by devices). |
OTHER | An origin of "OTHER" is used for values whose origin is known but which were neither collected nor derived. Examples include values sourced from the protocol or which are defined as part of the Trial Design preparation (see Section 7, Trial Design Model Datasets) or values created as a part of the preparation of the datasets (e.g., STUDYID, USUBJID, DOMAIN, --SEQ, --TESTCD). |
NOT AVAILABLE | "NOT AVAILABLE" means that the origin of the data is not available, such as data received from another laboratory, without the associated annotations or sufficient information provided to determine the actual Origin assignment for the data. Sponsors may specify additional details about the origin that may be helpful to the reviewer in the Comments section of the data definition file. |
To further illustrate the distinctions between these values:
A collected value, or value mapped directly from a collected value (e.g., --STRESC), has an origin of "COLLECTED".
A value derived from other collected values or populated fields (e.g., via calculations) has an origin of "DERIVED".
Values received from a vendor (e.g., a central laboratory) with undefined origin are considered "NOT AVAILABLE" rather than "COLLECTED" or "DERIVED".
Value-level Metadata
When a metadata attribute is specified at the variable level, that attribute's value applies to all values for that variable.
For some variables, a metadata attribute may require multiple values to describe all of the variable's values.
For example, the Organ Measurements (OM) domain could contain subject records related to both organ weights and organ ratios. In this case, some of the values (collected organ weights) would have an origin metadata attribute of "COLLECTED"; some of the values (derived organ ratios) would have an origin metadata attribute of "DERIVED". For variables with multiple attribute values, value-level metadata should be provided in the data definition file according to the Define.XML specification.
The following table illustrates how to define value-level metadata for this OM domain example.
Source Dataset | Source Variable | Value | Label | Origin |
OM | OMTESTCD | OW | Organ Weight | COLLECTED |
OM | OMTESTCD | OWBW | Organ to Body Weight Ratio | DERIVED |
OM | OMTESTCD | OMBR | Organ to Brain Weight Ratio | DERIVED |
Conformance with the SENDIG domain models is minimally indicated by:
Following the complete metadata structure for data domains
Following SENDIG domain models wherever applicable
Using SENDIG-specified standard domain names and prefixes per controlled terminology
Using SENDIG-specified standard variable names
Using SENDIG-defined variable labels for all standard domains
Using SDTM-specified data types for all variables
Following SDTM/SEND-specified controlled terminology and format guidelines for variables when provided
Including all collected and relevant derived data in one of the standard domains, special-purpose datasets, or general-observation class structures
Including all required and expected variables as columns in standard domains, and ensuring that all required variables are populated
Ensuring that each record in a dataset includes the appropriate identifier and timing variables as well as a topic variable
Conforming to all business rules described in the CDISC Notes column and general and domain-specific assumptions
Ensuring that the datasets are in SAS v5 transport file format or other transport file format required by a regulatory agency
Assumptions for Domain Models
The examples in this are not meant to show full domain structure and may omit variables for clarity when illustrating a particular scenario.
Additional Timing Variables
Additional timing variables (see SDTM v1.5 Table 2.2.5; https://www.cdisc.org/standards/foundational/sdtm/) can be added as needed to a standard domain model based on the 3 general observation classes. Timing variables can be added to special-purpose domains only where specified in the SENDIG domain model assumptions. Timing variables cannot be added to SUPP-- datasets or to RELREC (see Section 8, Representing Relationships and Data). Timing variables cannot be added to the Trial Design Model datasets (see Section 7, Trial Design Model Datasets).
The order of variables in the SDTM domain models has been chosen to facilitate the review and application of the models. Variables in the domains should be ordered with identifiers first, followed by the topic, qualifier, and timing variables. Within each role, variables are ordered as shown in SDTM v1.5 Tables 2.2.1-2.2.5 (http://www.cdisc.org/sdtm). The order of variables in the data definition file should reflect the order of variables in the dataset.
The concept of core variable is used both as a measure of conformance and to provide general guidance to sponsors. Three categories of variables are specified in the Core column in the domain models:
A required variable is any variable that is basic to the identification of a data record (i.e., essential key variables, topic variable) or which is necessary to make the record meaningful. Required variables must always be included in the dataset and cannot be null for any record.
An expected variable is any variable necessary to make a record useful in the context of a specific domain. Columns for expected variables must be present in each submitted dataset, even if all values are null. Expected variables may contain some null values, but in most cases will not contain null values for every record. When no data exist for an expected variable in the whole dataset, a null column should still be included in the dataset, and a comment should be included in the data definition file to explain the absence of data in the entire column.
A permissible variable should be used in a domain as appropriate when collected or derived. Except where restricted by specific domain assumptions, any SDTM timing and identifier variables and any qualifier variables from the same general observation class are permissible for use in a domain based on that general observation class. Sponsors may decide whether a permissible variable should be included as a column when all values for that variable are null.
Additional Guidance on Dataset File Naming
SEND datasets are named to be consistent with the domain code (see the Study Data Technical Conformance Guide for more details on naming datasets for submission to the FDA; https://www.fda.gov/media/88173/download). For example, the Demographics (DM) dataset is named dm.xpt. See SEND controlled terminology (available
at http://www.cdisc.org/terminology) for a list of standard and reserved domain codes. Exceptions to this rule are described in the following subsections for general-observation class datasets. See Section 8.2, Relating Records - RELREC, for RELREC; Section 8.3, Supplemental Qualifiers - SUPP-- Datasets, for SUPP; and Section 8.5, Relating Findings To Multiple Subjects - Subject Pooling, for POOLDEF.
General Variable Assumptions
SDTM variables are named according to a set of conventions, using fragment names (see SDTMIG v3.2, Appendix D; available at http://www.cdisc.org/sdtm), and must be represented in uppercase. These conventions should also be followed when defining --TESTCD in Findings domains and supplemental qualifier QNAM values. Variables with names ending in --CD are "short" versions of associated variables that do not include the --CD suffix (e.g., -- TESTCD is the short version of --TEST).
Values of --TESTCD and QNAM values must be limited to 8 characters, and cannot start with a number, nor can they contain characters other than letters, numbers, or underscores. This is to avoid possible incompatibility with SAS v5 transport files. This limitation will be in effect until the use of other formats (e.g., XML) becomes acceptable to regulatory authorities.
Because QNAM serves the same purpose as --TESTCD within supplemental qualifier datasets, values of QNAM are subject to the same restrictions as values of --TESTCD. Values of other --CD variables are not subject to the same restrictions as --TESTCD.
ETCD (the companion to ELEMENT), SETCD (the short name of a specific trial set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that they will need to serve as variable names.
ARMCD is limited to 20 characters, but does not have special character restrictions. The maximum length of ARMCD is longer than for other "short" variables to accommodate the kind of values that are likely to be needed for crossover studies. For example, if ARMCD values for a 7-period crossover were constructed using 2-character abbreviations for each treatment and separating hyphens, the length of ARMCD values would be 20.
Variable descriptive names (labels), up to 40 characters, should be provided as data variable labels. Variable names should be represented in uppercase.
Use of variable names (other than domain prefixes), formats, decodes, terminology, and data types for the same type of data (even for custom domains and supplemental qualifiers) should be consistent within and across studies within a submission. Sponsors must use the defined SENDIG-standard labels in all standard domains.
Two-character Domain Identifier
In order to minimize the risk of difficulty when merging or joining domains for reporting purposes, the 2-character domain identifier is used as a prefix in most variable names.
The 2-character domain code is limited to a to Z for the first character and A-Z or 0-9 for the second character, and it is always represented in uppercase. No special characters are allowed for compatibility with SAS v5 transport file format and file naming for the Electronic Common Technical Document (eCTD).
Identification of Subjects and Pools of Subjects
"Subject" should be used where applicable to generically refer to "animal." The term "subject" should be used consistently in all labels and comments. To identify a subject (animal) uniquely across all studies for all applications or submissions involving the product, a unique identifier (USUBJID) should be assigned to each subject on the study.
The unique subject identifier (USUBJID) or pool identifier (POOLID) is required in all datasets containing subject- level or pool-level data, respectively.
No more than 1 subject (animal) may have the same USUBJID within a submission. Additionally, the same animal that participates in multiple studies (when this is known) must be assigned the same USUBJID value in all studies.
POOLID must be unique for each unique grouping (pool) of subjects within a study. A subject can be in multiple pools, but each pool needs to be defined separately.
In this example, a monkey participated in both a pharmacokinetics study and a toxicology study; USUBJID has the same value across the studies, but there are different SUBJID values.
dm.xpt
Row | STUDYID | DOMAIN | USUBJID | SUBJID |
1 | CT1234 | DM | CT1234-007 | 007 |
dm.xpt
Row | STUDYID | DOMAIN | USUBJID | SUBJID |
1 | CT1234LTS | DM | CT1234-007 | 004 |
For information on pools of subjects, see Section 8.5, Relating Findings To Multiple Subjects - Subject Pooling.
Variables with controlled terminology should match the case in the controlled terminology list (see Section 4.3.2, Controlled Terminology Text Case). When extending a controlled terminology list, follow the case convention of that list.
Convention for Missing Values
Missing values for individual data items should be represented by nulls. Conventions for representing observations not done, using the SDTM --STAT and --REASND variables, are addressed in Section 4.5.1.3, Tests Not Done, and in the individual domain models.
Grouping Variables and Categorization
Grouping variables are identifiers and qualifiers that group records in the SDTM domains/datasets, such as the -- CAT (category) and --SCAT (subcategory) variables assigned by sponsors to categorize data. For example, a lab record with LBTEST = "SODIUM" might have LBCAT = "CHEMISTRY" and LBSCAT = "ELECTROLYTES".
Values for --CAT and --SCAT should not be redundant with the domain or dictionary classification provided by -- DECOD and --BODSYS.
STUDYID
DOMAIN
--CAT
--SCAT
USUBJID
--GRPID
--REFID
For the subject
All records with the same USUBJID value are a group of records that describe that subject.
Across subjects (records with different USUBJID values)
All records with the same STUDYID value are a group of records that describe that study.
All records with the same DOMAIN value are a group of records that describe that domain.
--CAT and --SCAT values further subset groups of tests within a domain. Generally, --CAT/--SCAT values have meaning within a particular domain, and apply to all subjects within that domain.
--GRPID values further group (subset) records within USUBJID. Unlike --CAT and --SCAT, --GRPID values are not intended to have any meaning across subjects and they are usually assigned during or after data collection.
Although --SPID and --REFID are identifier variables, these are usually not considered to be grouping variables, although they may have meaning across domains.
The primary distinctions between -CAT/ SCAT and --GRPID are:
--CAT/ SCAT are known (identified) about the data before it is collected. --CAT/ SCAT values group data across subjects. --CAT/-SCAT may have some controlled terminology.
--GRPID is usually assigned during or after data collection at the discretion of the sponsor. --GRPID groups data only within a subject. --GRPID values are sponsor-defined and are not be subject to controlled terminology.
The primary distinction between -CAT/ SCAT and --REFID is that --CAT/-SCAT are usually textual descriptions of the data designed into the collection vehicle/process, and --REFID is usually a tracking number/value of some type assigned to an object being tracked (e.g., a blood sample).
In domains based on the Findings general observation class, the --RESCAT variable can be used to categorize results after the fact. --CAT and --SCAT by contrast, are generally predefined or used at the point of collection, not after assessing the value of findings results. See Section 6.3.3.2, Examples for Clinical Observations (CL) Domain Model, Example 3.
Use of FOCID for Study-specific Points of Interest
Often, a specific part of a subject or specimen is identified as a study-specific point of interest (e.g., injection site, biopsy site, treated site, region of the body) and is commonly referenced in data collections and tabulations.
The FOCID variable enables representation of this concept, and is available within all general observation classes. When used, the variable serves as a cross-domain identifier for the study-specific focus of interest; any records relating to the same focus would have the same FOCID value. When populated, it is usually part of the natural key for the domain, providing a level of granularity that would otherwise not be available through the other variables. This is especially true when the foci are all within the same area on the subject.
The following examples demonstrate records from various domains that tie to study-specific foci (i.e., injection site 1 and injection site 2) as identified in the protocol. In each case, the FOCID variable is populated identically across domains for the same focus. Note that, in this example, many variables have been omitted due to space considerations.
At each of the 2 injection sites, subject 12345001 received a different treatment (Exposure domain).
ex.xpt
Row | STUDYID | DOMAIN | USUBJID | FOCID | EXTRT | EXDOSE | EXDOSU | EXSTDY |
1 | 12345 | EX | 12345001 | Injection Site 1 | RP187 | 0 | mg/kg | 1 |
2 | 12345 | EX | 12345001 | Injection Site 2 | RP187 | 10 | mg/kg | 1 |
Clinical signs (CL domain) are recorded at each of the 2 injection sites. Rows such as these would exist for each day on which observations of the sites were made.
cl.xpt
Row | STUDYID | DOMAIN | USUBJID | FOCID | CLTESTCD | CLTEST | CLORRES | CLDY |
1 | 12345 | CL | 12345001 | Injection Site 1 | SKINEX | Skin Examination | Fur, Thin Cover; Left Scapula | 1 |
2 | 12345 | CL | 12345001 | Injection Site 2 | SKINEX | Skin Examination | No Abnormal Findings, Right Scapula | 1 |
Macroscopic findings (MA domain) are recorded for the skin around the 2 injection sites.
ma.xpt
Row | STUDYID | DOMAIN | USUBJID | FOCID | MAORRES | MASPEC |
1 | 12345 | MA | 12345001 | Injection Site 1 | Fur thin cover | SKIN |
2 | 12345 | MA | 12345001 | Injection Site 2 | Unremarkable | SKIN |
Microscopic findings (MI domain) are recorded for 2 skin specimens, 1 from each injection site.
mi.xpt
Row | STUDYID | DOMAIN | USUBJID | FOCID | MIORRES | MISPEC |
1 | 12345 | MI | 12345001 | Injection Site 1 | Inflammation, acute | SKIN |
2 | 12345 | MI | 12345001 | Injection Site 2 | Injection channel visible, nothing remarkable | SKIN |
Use of the Invariant Record Identifier (--RECID)
The invariant record identifier (--RECID) is available for use in any domain based on 1 of the 3 general observation classes. This variable is an identifier for a record that is unique within a domain for a study. It remains invariant through subsequent versions of the dataset, even if the content of the record is modified. When a record is deleted, this value must not be reused to identify another record in either the current or future versions of the domain for the study.
It can facilitate the determination of which records have changed between versions of a dataset for a study. If the originating data collection process can distinguish whether a record is modified, this variable enables such a distinction to be passed on to subsequent systems.
Note that the concept for --RECID is distinct from --SEQ in several ways:
--SEQ is not required to be invariant through dataset versions.
--SEQ is numeric, whereas --RECID may be character based.
--SEQ is unique within a subject and a domain, whereas --RECID is unique across all records in a domain for the study.
See Section 8.2.2, RELREC Examples for Record-To-Record Relationships, for an example showing the use of -- RECID.
Use of the Unscheduled Flag (--USCHFL)
Nonclinical studies are conducted in the context of a planned study schedule. The identification of unscheduled observations is important information for interpretation of the data. The unscheduled flag (--USCHFL) variable is populated when the timing of a performed test or observation was not driven by the study schedule.
Nonclinical studies typically have a plan for handling unscheduled events (e.g., taking a final blood draw when an animal is found to be moribund). In this case, the protocol describes what to do for the unexpected event, but the collection is considered unscheduled because it is triggered by an unscheduled event (the animal's moribund condition); the value of --USCHFL would be set to "Y".
This example shows the disposition of 2 animals. The death of 1 of the animals was unscheduled.
Row | USUBJID | DSTERM | DSDECOD | DSSTDY | DSUSCHFL |
1 | 123-01 | Accidental Death | ACCIDENTAL DEATH | 28 | Y |
2 | 123-02 | Final Necropsy | TERMINAL SACRIFICE | 28 |
This example shows the laboratory records for 1 animal. The first 2 laboratory test results were performed as part of a scheduled blood draw, whereas the last 2 were performed on an unscheduled blood draw.
Row | USUBJID | LBTEST | LBORRES | LBORRESU | LBSTAT | LBREASND | LBDTC | LBDY | LBUSCHFL |
1 | 123-01 | Albumin | 30 | g/L | 2012-09-04T08:00 | 7 | |||
2 | 123-01 | Creatinine | 0.9 | mg/dL | 2012-09-04T08:00 | 7 | |||
3 | 123-01 | Albumin | 25 | g/L | 2012-09-11T06:45 | 14 | Y | ||
4 | 123-01 | Creatinine | NOT DONE | No reportable result | 2012-09-11T06:45 | 14 | Y |
Coding and Controlled Terminology Assumptions
Types of Controlled Terminology
Controlled terminology (CT) has been developed for SEND, and is available at http://www.cdisc.org/terminology. If a controlled terminology codelist exists for a variable in a SEND domain, the name of the codelist will be populated in the Controlled Terms, Codelist, or Format column of the domain model to indicate that a distinct set of controlled values exists and is expected to be used. The SEND CT indicates whether a particular codelist is extensible. The domain dataset models included in Sections 5, Models for Special-purpose Domains, and 6, Domain Models Based on the General Observation Classes, of this document provide additional information about the Controlled Terms, Codelist, or Format column; notes on proper use; and examples.
Controlled Terminology Text Case
Controlled terminology should be submitted in the same text case used in the controlled terminology list. When extending a controlled terminology list, the case-sensitivity convention of that list should be followed.
Deviations from these rules should be described in the data definition file.
Controlled Terminology Values
The controlled terminology or a link to the controlled terminology should be included in the data definition file wherever applicable. See the Define-XML specification (available at https://www.cdisc.org/standards/data- exchange/) for details on including or referencing controlled terminology lists. Note that a null value should not be included in the permissible value set. A null value is implied for any list of controlled terms unless the variable is required (see Section 4.1.3, Core Variables).
Use of Controlled Terminology and Arbitrary Codes
Controlled terminology or decoded text should be used instead of arbitrary number or text codes in order to reduce ambiguity for submission reviewers. If such codes are necessary for analysis and a sponsor wishes to submit them, they may be submitted as supplemental qualifiers.
Use of “Yes” and “No” Values
In the case of variables for which the response is "Yes" or "No" ("Y" or "N") and the controlled terminology list is YN, the CDISC Notes column will provide guidance for proper use within a domain. Where appropriate and to eliminate confusion regarding whether a blank response indicates "N" or is a missing value, it is suggested that both "Y" and "N" be used, except where the CDISC Notes instruct otherwise.
Use of Combined Terms for Qualifier Variables
In some cases, a single variable value may be a combination of items representing a single concept (e.g., --SPEC). In others, there may be multiple values represented. The differences between the 2 cases are described in the following sections.
A Single Concept Represented by Multiple Values
A single value may represent a combination of multiple contributing items, delimited by slashes ("/"). In these cases, the combination is the collected value, the value analyzed, and so on—not the individual contributing items composing the value.A noteworthy example of this scenario is combined specimens, where a single specimen may consist of material from various tissues, and the combination is examined and analyzed together during an
examination. For example, a specimen consisting of testis and epididymis tissues would be included as "TESTIS/EPIDIDYMIS". Another example is the DEGENERATION/REGENERATION microscopic finding: a single concept represented by multiple values (which is different from having 2 separately collected findings of degeneration and regeneration, respectively).In these scenarios, when controlled terminology applies to the corresponding variable, the combination may already exist as a controlled terminology term; in the specimen list, this is the case for several commonly combined tissues. However, there do exist combinations that do not have a dedicated controlled term and whose rarity does not warrant creating an individual controlled term for the specific combination. In these cases, when constructing the combination term, each of the contributing items should abide by controlled terminology where possible, in order to keep the combination term consistent and easily interpretable. For example, in the TESTIS/EPIDIDYMIS case, TESTIS (the preferred term for this tissue) should be used instead of TESTES, Testis, testes, and so on, and EPIDIDYMIS should be used instead of EPIDIDYMIDES or other variations. As always, the SEND Controlled Terminology Team will evaluate feedback regarding potential new terms.
Multiple Concepts Represented by Multiple Values
In some cases, a variable value may comprise multiple individual values. In these cases, each contributing value is a separately collected or analyzed item. This case is notably present in the directionality (--DIR), where often, multiple distinct values might be collected for a given record. In these scenarios, when controlled terminology applies to the corresponding variable, each contributing value must be included as its controlled terminology submission value, and delimited from other terms by a semicolon. For example, a finding with 2 directionality values of ventral and surface would be included as "VENTRAL;SURFACE."
Mapping Controlled Terminology
Many terms are synonyms of other terms. When there are multiple terms that express the same base concept, SEND controlled terminology provides the preferred term to include in a submission, and thus the term to which the synonymous term(s) should be mapped. The NCI Thesaurus (https://ncit.nci.nih.gov) provides the synonyms. For instance, the unit of degrees Celsius could be expressed as "°C", "degC", "C", "Degrees Celsius", and so on. The SEND preferred term for degrees Celsius is "C." Temperature can also be expressed in terms of degrees Fahrenheit, but this is a different concept from degrees Celsius. The key to mapping is determining which terms are synonymous, not which terms can be converted into one another via a conversion factor (for conversion, see Section 4.5.1.4, Example of Original and Standardized Results and Test Not Done).
Finding the submission value for a source value can be done in 2 ways. First, searching the controlled terminology list can determine whether the source value is in the list. If it is not, the easiest way to search for synonyms is the NCI Thesaurus. The NCI Thesaurus's search functionality searches terms and synonyms and provides the SEND submission value (preferred term).
This example illustrates mapping source units into their controlled terminology preferred term for --ORRESU. Note that in each case, there is only a label change (no conversion calculation).
Row | Source Unit | Submission Value (--ORRESU) |
1 | Celsius | C |
2 | microgram per liter | ug/L |
3 | ng/mL | ug/L |
Timing variables (see SDTM v1.5, Table 2.2.5, available at https://www.cdisc.org/standards/foundational/sdtm/) are an essential component of all SDTM subject-level domain datasets. In general, all domains based on the 3 general observation classes should have at least one timing variable. In the Events or Interventions general observation class,
this could be the start date of the event or intervention. In the Findings observation class, where data are usually collected on multiple study days, either --DTC or --DY must be used. The SENDIG requires dates and times of day to be represented according to the international standard ISO 8601 (https://www.iso.org). ISO 8601 provides a text- based representation of dates and/or times, intervals of time, and durations of time.
Formats for Date/Time Variables
A date/time character string (--DTC variable) may include data that is represented in ISO 8601 format as a complete date/time, a partial date/time, or an incomplete date/time.
The SENDIG template uses ISO 8601 for calendar dates and times of day, which are expressed as follows:
YYYY-MM-DDThh:mm:ss
In this format:
[YYYY] = 4-digit year
[MM] = 2-digit representation of the month (01-12; e.g., 01 = January)
[DD] = 2-digit day of the month (01-31)
[T] = time designator; indicates time information follows
[hh] = 2 digits of hour (00-23; am/pm is NOT allowed)
[mm] = 2 digits of minute (00-59)
[ss] = 2 digits of second (00-59)
Other characters defined for use within the ISO 8601 standard are:
[-] (hyphen): to separate the time elements "year" from "month" and "month" from "day"
[:] (colon): to separate the time elements "hour" from "minute" and "minute" from "second"
[/] (solidus or slash): to separate components in the representation of time intervals (see Section 4.4.3, Intervals of Time and Use of Duration for --DUR Variables)
[P] (duration designator): precedes the components that represent the duration (see Section 4.4.3, Intervals of Time and Use of Duration for --DUR Variables)
Spaces are not allowed in any ISO 8601 representations. Key aspects of the ISO 8601 standard:
ISO 8601 represents dates as a text string using the notation YYYY-MM-DD.
ISO 8601 represents times as a text string using the notation hh:mm:ss.
The ISO 8601 basic format, which does not require delimiters, should not be used.
When a date is collected with a time in the same variable (as a date/time), the date is written in front of the time and the time is preceded with "T" using the notation YYYY-MM-DDThh:mm:ss (e.g., 2001-12- 26T00:00:01).
Implementation of the ISO 8601 standard means that date/time variables are character/text data types. The SEND fragment employed for date/time character variable names is DTC.
The concept of representing date/time precision is handled through use of the ISO 8601 standard. According to ISO 8601, precision (also referred to by ISO 8601 as completeness or representations with reduced accuracy) can be inferred from the presence or absence of components in the date and/or time values. Missing components are represented by right truncation or a hyphen (for intermediate components that are missing). If the date and time values are completely missing, the SDTM date field should be null. Every component is represented as 2 digits except years, which are represented as 4 digits. One-digit numbers are always padded with a leading zero.
The following table provides examples of ISO 8601 representation complete date and truncated date/time values using ISO 8601-appropriate right truncations of incomplete date/time representations. Note that if no time component is represented, the [T] time designator (in addition to the missing time) must be omitted in ISO 8601 representation.
Date and Time as Originally Recorded | Precision | ISO 8601 Date/Time | |
1 | December 15, 2003 13:14:17 | Complete date/time | 2003-12-15T13:14:17 |
2 | December 15, 2003 13:14 | Unknown seconds | 2003-12-15T13:14 |
3 | December 15, 2003 13 | Unknown minutes and seconds | 2003-12-15T13 |
4 | December 15, 2003 | Unknown time | 2003-12-15 |
5 | December, 2003 | Unknown day and time | 2003-12 |
6 | 2003 | Unknown month, day, and time | 2003 |
This date and date/time model also provides for the representation of intervals with uncertainty or date/time ranges. To represent these intervals while applying the ISO 8601 standard, it is recommended that sponsors concatenate the date/time values that describe the beginning and the end of the interval of uncertainty (using the most complete representation of the dates/times known) and separate them with a solidus or slash, as shown in the following table.
Interval of Uncertainty | ISO 8601 Date/Time | |
1 | Between 10:00 and 10:30 on the morning of December 15, 2003 | 2003-12-15T10:00/2003-12-15T10:30 |
2 | Between the first and the tenth of December, 2003 | 2003-12-01/2003-12-10 |
3 | Sometime in the first half of 2003 | 2003-01-01/2003-06-30 |
Other uncertainty intervals may be represented by the omission of components of the date when these components are unknown or missing. As previously mentioned, ISO 8601 represents missing intermediate components through the use of a hyphen where the missing component would normally be represented. This may be used in addition to "appropriate right truncations" for incomplete date/time representations. When components are omitted, the expected delimiters must still be kept in place and only a single hyphen is to be used to indicate an omitted component. Examples of this method of representing omitted components are shown in the following table.
Date and Time as Originally Recorded | Level of Uncertainty | ISO 8601 Date/Time | |
1 | December 15, 2003 13:15:17 | Complete date and time | 2003-12- 15T13:15:17 |
2 | December 15, 2003 ??:15 | Unknown hour with known date and minutes | 2003-12-15T-:15 |
3 | December 15, 2003 13:??:17 | Unknown minutes with known date, hours, and seconds | 2003-12-15T13:-:17 |
4 | The 15th of some month in 2003, time not collected | Unknown month and time with known year and day | 2003---15 |
5 | December 15, but year not documented, time not collected | Unknown year and time with known month and day | --12-15 |
6 | 7:15 of some unknown date | Unknown date with known hour and minute | - T07:15 |
Using a character-based data type to implement the ISO 8601 date/time standard will ensure that the date/time information will be machine- and human-readable without the need for further manipulation and will be platform- and software-independent.
Intervals of Time and Use of Duration for --DUR Variables
As defined by ISO 8601, an interval of time is the part of a time axis, limited by 2 time "instants," such as the times represented in SDTM by the variables --DTC and --ENDTC. These variables represent the 2 instants that bound an interval of time, whereas the duration is the quantity of time that is equal to the difference between these time points.
Duration is frequently used during a review; however, the duration timing variable (--DUR) should generally be used in a domain if it was collected in lieu of a start date/time (DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC are collected, durations can be calculated by the difference in these 2 values and need not be in the submission dataset.
Durations and associated units can be provided in a single variable, in accordance with the ISO 8601 standard as follows:
PnYnMnDTnHnMnS
- or -
PnW
In this format:
[P] (duration designator) precedes the alphanumeric text string that represents the duration. Note: the use of the character P is based on the historical use of the term "period" for duration.
[n] represents a positive real number. It can be zero only in the case where a duration [P] is zero.
[W] is used as week designator, preceding a data element that represents the number of calendar weeks within the calendar year (e.g., P6W represents 6 weeks of calendar time).
The letter P must precede other values in the ISO 8601 representation of duration. The n preceding each letter represents the number of years, months, days, hours, minutes, or seconds, or the number of weeks if the duration is expressed in calendar weeks. As with the date/time format, T is used to separate the date components from time components.
Note: In duration expressions, weeks cannot be mixed with any other date/time components such as days or months.
As is the case with the date/time representation in --DTC or –ENDTC, only the components of duration that are known or collected need to be represented. Also, as is the case with the date/time representation, if no time component is represented, the [T] time designator (in addition to the missing time) must be omitted in ISO 8601 representation.
ISO 8601 allows an interval to be represented in multiple ways. One representation, shown below, uses 2 dates in the format:
YYYY-MM-DDThh:mm:ss/YYYY-MM-DDThh:mm:ss
For the purposes of data submission, an additional format is allowed to represent "negative" intervals of time (intervals of time preceding a reference point). This format should be expressed as:
-PnYnMnDTnHnMnS
- or -
-PnW
This may be used whenever the ISO 8601 interval format is specified in this implementation guide.
ISO 8601 also allows that the "lowest order components" of duration/intervals may be represented in decimal format. This may be useful if data are collected in formats such as "one and one-half years," "two and one-half weeks," "one-half week," or "one quarter of an hour," and the sponsor wishes to represent this level of precision (or lack of precision) in ISO 8601 representation. Using decimals to express an additional level of precision is ONLY allowed in the lowest-order (right-most) component of any duration representation.
The following table provides some examples of ISO 8601 representations of durations.
Duration as Originally Recorded | ISO 8601 Duration |
2 years | P2Y |
10 weeks | P10W |
3 months 14 days | P3M14D |
3 days | P3D |
6 months 17 days 3 hours | P6M17DT3H |
14 days 7 hours 57 minutes | P14DT7H57M |
42 minutes 18 seconds | PT42M18S |
Duration as Originally Recorded | ISO 8601 Duration |
One-half hour | PT0.5H |
5 days 12¼ hours | P5DT12.25H |
4 ½ weeks | P4.5W |
5 minutes pre-dose | -PT5M |
Date and time elements, including their designator, should be omitted if their value is zero. For example, duration of 1 hour and 30 seconds (no minutes) should be represented as PT1H30S. Note that a leading zero is required with decimal values less than 1. An exception to the use of zeros in ISO 8601would be a representation of zero time (e.g., PT0H or PT0M).
Populating Study Day Variables
The study day variables (--DY, --STDY, and --ENDY) describe the relative day of the observation, starting with the reference date as day 1. They are determined by comparing the date portion of the respective date/time variables (-- DTC, --STDTC, and --ENDTC) to the date portion of the subject reference start date (RFSTDTC from the Demographics domain).
The subject reference start date (RFSTDTC) is designated as study day 1. The study day value is incremented by 1 for each day following RFSTDTC. Dates prior to RFSTDTC are decremented by 1, with the date preceding RFSTDTC designated as study day -1 (there is no study day 0). This algorithm for determining study day is consistent with how sequential days relative to a fixed reference point are typically described, but creates problems if used for mathematical calculations because this does not allow for a day 0. Therefore, study day is not suited for use in subsequent numerical computations (e.g., calculating duration). In such calculations, the raw date values should be used rather than study day.
All study day values are integers. Thus, to calculate study day:
--DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC
--DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC This algorithm should be used across all domains.
VISITDY was described in SENDIG v3.0 in several different ways, including:
"Used to group records into a single planned study day as a label for reporting. This allows data that was collected based upon grace days to be reported in a single column on a report. The usage of VISITDY should be defined in the define file." (See Section 4.4.4, Populating Study Day Variables)
"This is the planned study day of collection." (See Section 6.3.1, Body Weight – BW)
These concepts cannot be represented through the use of a single variable. Further, because VISITDY is associated with the clinical encounter (VISIT), it is not the appropriate variable to represent these concepts. As a result, VISITDY will be phased out of the SENDIG and initially replaced with reporting variables (--NOMDY and -- NOMLBL). Adding variables to represent planned information may be considered for a future version of the SENDIG. Implementation of VISITDY is not recommended at this time. Existing implementations of SEND may discontinue or continue use of VISITDY as feasible. Conformance with SENDIG v3.1.1 is not dependent on the use of VISITDY.
Observations recorded on multiple days frequently get reported under a single day; therefore, the variables -- NOMDY and --NOMLBL have been created. --NOMDY is used to group records collected over multiple days under a single nominal study day for reporting purposes. --NOMLBL is a label for a given value of --NOMDY as presented in the study report (e.g., "Week 4", "Day 28", "Terminal Sac"). The value of --NOMLBL does not have to be unique for a given value of --NOMDY. These timing variables have been included in domains where they may be commonly used, but may be added to any general observation class domain as needed. It is not recommended that -- NOMLBL be used without --NOMDY.
The following example shows the basic timing variables populated for animal dispositions based upon a planned sacrifice that occurred over 3 days at the end of a 4-week study. All the planned sacrifices were reported under 1 study day, shown in DSNOMDY.
ds.xpt
Row | USUBJID | DSSTDTC | DSSTDY | DSNOMDY | DSNOMLBL |
1 | 123-1 | 2012-09-04 | 28 | 28 | Week 4 Terminal Sacrifice |
2 | 123-2 | 2012-09-04 | 28 | 28 | Week 4 Terminal Sacrifice |
3 | 123-3 | 2012-09-05 | 29 | 28 | Week 4 Terminal Sacrifice |
4 | 123-4 | 2012-09-06 | 30 | 28 | Week 4 Terminal Sacrifice |
Representing Additional Study Days
The SDTM allows for --DTC values to be represented as study days (--DY) relative to RFSTDTC in the Demographics DM dataset (as described in Section 4.4.4, Populating Study Day Variables). The calculation of additional study days within subdivisions of time in a study may be based on 1 or more defined reference dates not represented by RFSTDTC. In such cases, sponsors may define supplemental qualifier variables to store these study days; the data definition file should reflect the reference dates used to calculate such study days. If a sponsor wishes to define "day" within ELEMENT or "day" within EPOCH, the reference date/time will be an element start date/time in the Subject Elements dataset (see Section 5.3.1, Subject Elements – SE).
Representing Timing in a Findings Domain
Date and Time in a Findings Domain
When the date/time of collection is presented in any domain, the date/time should go into the --DTC field (e.g., EGDTC for date/time of ECG). For any domain based on the Findings general observation class (e.g., lab tests based on a specimen), the collection date usually needs to be tied to when the specimen or source of the finding was captured, not necessarily when the data was recorded. In order to ensure that the critical timing information is always represented in the same variable, the --DTC variable is used to represent the time of specimen collection. For example, in the Laboratory Test Results (LB) domain, the LBDTC variable would be used for all single-point blood collections or spot urine collections. For timed lab collections (e.g., 24-hour urine collections), the LBDTC variable would be used for the start date/time of the collection and LBENDTC for the end date/time of the collection. This approach allows single-point and interval collections to use the same date/time variables consistently across all datasets for the Findings general observation class. The following table illustrates the proper use of these variables. Note that --STDTC should not be used in a Findings domain (the table is not meant to show domain structure, but to show which variables could be used, designated by the "X").
Collection Type | --DTC | --STDTC | --ENDTC |
Single-point collection | X | ||
Interval collection | X | X |
Body weights are single-point collections.
BWDTC | BWDY |
2012-09-04 | 7 |
2012-09-11 | 14 |
2012-09-19 | 22 |
2012-09-25 | 28 |
Food consumption is interval collection.
FWDTC | FWENDTC | FWDY | FWENDY |
2012-09-04 | 2012-09-11 | 7 | 14 |
2012-09-11 | 2012-09-19 | 14 | 22 |
2012-09-19 | 2012-09-25 | 22 | 28 |
Most domains, especially Findings domains, have basic timing variables expressing the actual timing of the observation. The variables used to describe time can vary between point-in-time observations (e.g., body weights) and duration-based observations (e.g., food consumption).
Actual timing for point-in-time observations is expressed through the following variables:
--DTC is the date when the observation occurred. Depending on the precision of the date, this can represent just the date (e.g., 2010-12-31) or a date and time (e.g., 2010-12-31T08:00). The --DTC variable is expected for many Findings domains.
--DY is the study day when the observation actually occurred, relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain.
These variables are shown in Figure 4471A.
Some observations may be associated with an interval of time (e.g., a finding evaluated over 2 hours). The following variables enable the definition of these ranges:
--ENDTC is the end date of the range of time when the observation occurred. Depending on the precision of the time, this can represent just the date (e.g., 2010-12-31) or a date and time (e.g., 2010-12-31T08:00).
--ENDY is the end day of the range of time when the observation occurred, relative to the sponsor-defined RFSTDTC variable in the DM domain.
In these cases, the --DTC/--DY variables are used to define the start of the interval. These variables are shown in Figure 4471B, in a case where an observation spanned 2 days.
Planned Instances of an Activity Within a Study Day
If there are multiple planned instances of the same activity during a study day, and those instances are not scheduled at planned time intervals relative to a fixed reference point (e.g., administration of dose), the time point variables -- TPT and --TPTNUM can be used to differentiate the instances. These 2 variables are used as follows:
--TPT: the label for the time point during the study day (e.g., "AM", "PM")
--TPTNUM: typically indicates the order of the time points (TPT) during the study day for the category and/or subcategory (CAT/--SCAT) of data within a domain. The sequence number of the time point during the day (e.g., 1 for --TPT = "AM", 2 for --TPT= "PM")
For each unique planned time point (--TPT), there must be a one-to-one relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is determined by a combination of the domain; study day; and, if present, category and/or subcategory (CAT/--SCAT).
Other variables (e.g., --TESTCD, --METHOD) may also be needed in some cases to define uniqueness. When this occurs, clarification should be provided as a comment to --TPTNUM in the define file.
Example 1: Basic Timing for Single and Multiple Observations
The following example illustrates the basic timing for single observations as well as multiple observations over the course of the day. The --TPT variable provides a label for each of the sessions; the --TPTNUM allows the sessions to be sorted to correctly reflect the planned order during the day.
Rows 1 and 2 demonstrate one time point per study day being populated for --TPT and --TPTNUM. For observations that only occur once per day, the use of --TPT and --TPTNUM is acceptable, but not required.
cl.xpt
Row | CLCAT | CLSCAT | CLDTC | CLDY | CLTPT | CLTPTNUM |
1 | PHYSICAL EXAM | Physical Examination | 2012-09-04T08:00 | 7 | Vet Check | 1 |
2 | OPHTHALMOLOGY | Ophthalmic Signs | 2012-09-04T14:30 | 7 | Slit Lamp | 1 |
3 | CLINICAL SIGNS | Clin Signs | 2012-09-11T06:45 | 14 | AM | 1 |
4 | CLINICAL SIGNS | Clin Signs | 2012-09-11T13:45 | 14 | PM | 2 |
5 | CLINICAL SIGNS | Clin Signs | 2012-09-11T14:45 | 14 | Detailed Obs | 3 |
6 | CLINICAL SIGNS | Cage-side observations | 2012-09-04T08:30 | 7 | AM | 1 |
7 | CLINICAL SIGNS | Cage-side observations | 2012-09-04T15:30 | 7 | PM | 2 |
8 | CLINICAL SIGNS | Cage-side observations | 2012-09-11T08:10 | 14 | AM | 1 |
9 | CLINICAL SIGNS | Cage-side observations | 2012-09-11T15:45 | 14 | PM | 2 |
10 | CLINICAL SIGNS | Cage-side observations | 2012-09-11T16:10 | 14 | Visual Check | 4 |
Example 2: Point-in-time Time Points, Usage Across Days
The following example shows some of the time point variables for clinical observations measurements taken pre- dose and at 1 and 4 hours post-dose relative to a once-daily dose on days 1 and 2 of the study. Note that the --TPT and --TPTNUM variables have the same values across days for the same time point.
CLDY | CLTPT | CLTPTNUM |
1 | PREDOSE | 1 |
1H | 2 | |
4H | 3 | |
2 | PREDOSE | 1 |
1H | 2 | |
4H | 3 |
Example 3: Representing Timing for Observational Durations with EVLINT
The following example shows electrocardiographic examinations conducted for 1 hour in the morning and 1 hour in the afternoon on day 1. The timing of the start of each examination is not relative to any time-point reference (TPTREF). EGEVLINT conveys that each examination was 1 hour in duration, when the relative start/end from a fixed reference point is not available.
eg.xpt
Row | EGTEST | EGDTC | EGDY | EGTPT | EGTPTNUM | EGEVLINT |
1 | Summary (Mean) Heart Rate | 2012-09-04T08:00 | 1 | AM | 1 | PT1H |
2 | Summary (Mean) Heart Rate | 2012-09-04T14:30 | 1 | PM | 2 | PT1H |
3 | Summary (Mean) PR Duration | 2012-09-04T08:00 | 1 | AM | 1 | PT1H |
4 | Summary (Mean) PR Duration | 2012-09-04T14:30 | 1 | PM | 2 | PT1H |
5 | Summary (Mean) QRS Duration | 2012-09-04T08:00 | 1 | AM | 1 | PT1H |
6 | Summary (Mean) QRS Duration | 2012-09-04T14:30 | 1 | PM | 2 | PT1H |
7 | Summary (Mean) QT Duration | 2012-09-04T08:00 | 1 | AM | 1 | PT1H |
8 | Summary (Mean) QT Duration | 2012-09-04T14:30 | 1 | PM | 2 | PT1H |
9 | QTcF - Fridericia's Correction Formula | 2012-09-04T08:00 | 1 | AM | 1 | PT1H |
10 | QTcF - Fridericia's Correction Formula | 2012-09-04T14:30 | 1 | PM | 2 | PT1H |
Planned Time Points Relative to a Fixed Reference Point
If instances of an activity are scheduled at planned time intervals relative to a fixed reference point (e.g., administration of a dose), the following timing variables should be used:
--TPTREF: the description of the fixed reference point event or "anchor" from which the planned observation will be made, usually the dose (e.g., "Day 1 Dose"; "Day 1, Dose 1").
--ELTM: the planned elapsed time from the fixed reference point event (e.g., a dose) to the planned observation, in ISO 8601 format, which is usually also reflected in the --TPT label. For example, if an observation is planned for 30 minutes after the day 1 dose (e.g., --TPT = "30 minute postdose"), --TPTREF would be "Day 1 Dose" with an --ELTM of PT30M.
--TPT: the label for the time point relative to –TPTREF planned observation, typically reflecting --ELTM. For example, if --TPT is "30 minute postdose," then --ELTM would be PT30M; a "1 hour" --TPT would have an --ELTM of PT1H .
--TPTNUM: indicates the order of the time points (TPT) relative to the fixed reference point (TPTREF) for the category and/or subcategory (CAT/--SCAT) of data within a domain. The ordering/sequence number of the time point (e.g., 1, 2, 3) is sponsor-defined, but is usually at least unique within the given interval. For example, for a given day with 3 time points (pre-dose, 30 minutes post-dose, 1 hour post-dose), -- TPTNUM could be 1 for pre-dose, 2 for 30 minutes post-dose, and 3 for 1 hour post-dose, to establish their relative order.
For each unique planned time point (--TPT), there must be a one-to-one relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is determined by a combination of the domain, fixed reference point (TPTREF), and (if present) category and/or subcategory (CAT/--SCAT).
Other variables (e.g., --TESTCD, --METHOD) may also be needed in some cases to define uniqueness. When this occurs, clarification should be provided as a comment to --TPTNUM in the define file.
--RFTDTC is used to represent the actual date/time of the fixed reference point (--TPTREF).
Example 1: Point-in-Time Time Points, Clinical Observations Prior to Dose Through 90 Minutes Postdose
The following example shows time point variables populated for clinical observation measurements taken 1 hour before dosing and at 30, 60, and 90 minutes after dosing. The actual times, as represented by CLDTC, did not adhere exactly to the planned times.
Note: If the pre-dose time point had no specific planned elapsed time, CLELTM would be null.
cl.xpt
Row | CLDTC | CLDY | CLTPT | CLTPTNUM | CLELTM | CLTPTREF | CLRFTDTC |
1 | 2006-08-01T07:25 | 1 | Predose | 1 | -PT1H | Day 1 Dose | 2006-08-01T08:00 |
2 | 2006-08-01T08:30 | 1 | 30 MIN | 2 | PT30M | Day 1 Dose | 2006-08-01T08:00 |
3 | 2006-08-01T09:01 | 1 | 60 MIN | 3 | PT1H | Day 1 Dose | 2006-08-01T08:00 |
4 | 2006-08-01T09:32 | 1 | 90 MIN | 4 | PT1H30M | Day 1 Dose | 2006-08-01T08:00 |
Not all time points will require all of these variables; however, it is anticipated that at least --TPTNUM will be included, and generally --TPT, to give the time point a label.
Because --RFTDTC represents the actual date/time of the fixed reference point (--TPTREF), --TPTREF should be provided whenever --RFTDTC is populated. It is also highly recommended that --TPTREF be as specific as possible when --RFTDTC is not used or is null. For example, a --TPTREF of "DOSE ADMINISTRATION" without a corresponding --RFTDTC is not very meaningful if there are multiple dose administrations within a study.
Example 2: Point-in-Time Time Points, Clinical Observations with 24-hour Time Points
The following example shows time point variables populated for clinical observation measurements taken pre-dose and 1, 4, and 24 hours relative to dosing performed on the morning and afternoon of days 7 and 14 of the study. The variables --TPTREF and --RFTDTC describe the reference time point. The example also shows that the assessments performed 24 hours after dosing on study days 8 and 15 (CLDY) are grouped for reporting with the assessments performed on the study day of dosing using nominal day values (CLNOMDY) of 7 and 14, and the reporting labels (CLNOMLBL) of week 1 and week 2.
cl.xpt
Row | CLDY | CLNOMDY | CLNOMLBL | CLTPT | CLTPTNUM | CLELTM | CLTPTREF | CLRFTDTC |
1 | 7 | 7 | Week 1 | PREDOSE | 1 | PT0H | DAY 7 DOSE | 2006-08-01T08:00 |
2 | 7 | 7 | Week 1 | 1H | 2 | PT1H | DAY 7 DOSE | 2006-08-01T08:00 |
3 | 7 | 7 | Week 1 | 4H | 3 | PT4H | DAY 7 DOSE | 2006-08-01T08:00 |
4 | 8 | 7 | Week 1 | 24H | 4 | PT24H | DAY 7 DOSE | 2006-08-01T08:00 |
5 | 14 | 14 | Week 2 | PREDOSE | 1 | PT0H | DAY 14 DOSE | 2006-08-08T08:00 |
6 | 14 | 14 | Week 2 | 1H | 2 | PT1H | DAY 14 DOSE | 2006-08-08T08:00 |
7 | 14 | 14 | Week 2 | 4H | 3 | PT4H | DAY 14 DOSE | 2006-08-08T08:00 |
8 | 15 | 14 | Week 2 | 24H | 4 | PT24H | DAY 14 DOSE | 2006-08-08T08:00 |
Planned Time Points Within a Duration
Time points with collections over a duration also typically include the --STINT and --ENINT variables, which specify the start and end of the period over which the assessment was evaluated, based on the --TPTREF anchor.
For these duration-based time points, the sponsor can choose the --TPT (and corresponding --ELTM) to be based on the end, start, or somewhere in the middle of the assessment interval; however, the --STINT and --ENINT variables will remain the same for the same assessment interval. In this respect, --TPT and --ELTM act as the "label" for where the time point should be considered. The --STINT and --ENINT variables definitively state the bounds of the evaluation and would represent the assessment interval consistently across sponsors, regardless of labeling style.
Figure 44723A shows a duration-based time point where --TPT is based at the end of the assessment interval, such as if there were a time point labeled "1 hour," representing an evaluation of the last hour of data. This is the most typical way that duration-based time points are represented.
Another way to express a duration-based time point is based on the beginning of the assessment interval, such as a time point labeled "0 hour", representing an evaluation of the next hour of data. This scenario is shown in Figure 44723B. Note that --STINT and --ENINT are identical to that in Figure 44723A; only --TPT and its associated -- ELTM change.
Another less common way to express a duration-based time point is based on a window around the time point, such as a time point labeled "30 minute", representing an assessment interval of 30 minutes before and after the 30- minute mark. This scenario is shown in Figure 44723C. Note that --STINT and --ENINT are identical compared to Figures 44723A and 44723B; only --TPT and its associated --ELTM change.
Example 1: Duration-based Time Points Based on the End of the Assessment
In this example, at each hour, the previous hour's data are summarized into the result. Thus, --TPT and --ELTM are defined around the end of the assessment (e.g., the zero- to 1-hour period assigned to RETPT of "1 Hour" and REELTM of "PT1H"), with the assessment period bounded by the RESTINT and REENINT (e.g., the zero- to 1- hour period assigned to RESTINT of PT0H and REENINT of PT1H).
re.xpt
Row | RETPT | RETPTNUM | REELTM | RETPTREF | RESTINT | REENINT |
1 | Baseline | 0 | PT0H | Day 1 Dose | -PT1H | PT0H |
2 | 1 Hour | 1 | PT1H | Day 1 Dose | PT0H | PT1H |
3 | 2 Hour | 2 | PT2H | Day 1 Dose | PT1H | PT2H |
Example 2: Duration-based Time Points Based on the Start of the Assessment
The following table presents the same scenario as the previous example, except with the time point based on the start of the assessment. At each hour, the following hour's data are summarized into the result. Thus, --TPT and -- ELTM are defined around the start of the assessment (e.g., the zero- to 1-hour period assigned to RETPT of "0 Hour" and REELTM of "PT0H"), yet RESTINT and REENINT are populated identically to the previous example (it remains the same period of time regardless of the label used).
re.xpt
Row | RETPT | RETPTNUM | REELTM | RETPTREF | RESTINT | REENINT |
1 | Baseline | 0 | -PT1H | Day 1 Dose | -PT1H | PT0H |
2 | 0 Hour | 1 | PT0H | Day 1 Dose | PT0H | PT1H |
3 | 1 Hour | 2 | PT1H | Day 1 Dose | PT1H | PT2H |
Example 3: Duration-based Time Points Based in the Middle of the Assessment
The following table presents the same scenario as in Example 2, except with the time point based in the middle of the assessment; 30 minutes of data on either side of each time point (time points at 30 minutes pre-dose and 30 and 90 minutes post-dose) count toward the time point's assessment period. To represent this case, --TPT and --ELTM are defined at the desired time, with the RESTINT and REENINT set to the start and end of the window.
Row | RETPT | RETPTNUM | REELTM | RETPTREF | RESTINT | REENINT |
1 | Baseline | 0 | -PT30M | Day 1 Dose | -PT1H | PT0H |
2 | 0.5 Hour | 1 | PT30M | Day 1 Dose | PT0H | PT1H |
3 | 1.5 Hour | 2 | PT90M | Day 1 Dose | PT1H | PT2H |
Original and Standardized Results of Findings and Tests Not Done
Original and Standardized Results
The --ORRES variable contains the result of the measurement or finding as originally received or collected. ORRES is an expected variable and should always be populated, except when --STAT = "NOT DONE".
When --ORRES is populated, --STRESC must also be populated, regardless of whether the data values are character or numeric. The --STRESC variable is either derived by the conversion of values in --ORRES to values with standard units, or by the assignment of the value of --ORRES (as in the Clinical Observations domain, where -- STRESC could contain a dictionary-derived term). In the Macroscopic and Microscopic Findings (MA/MI)
domains, --ORRES may contain a finding with multiple concatenated modifiers. In this case, --STRESC would contain only the finding without the modifiers. A further step is necessary when --STRESC contains numeric values. These are converted to numeric type and written to --STRESN. Because --STRESC may contain a mixture of numeric and character values, --STRESN may contain null values, as shown in the following flowchart.
When the original measurement or finding is a selection from a defined codelist, in general, the --ORRES and -- STRESC variables contain results in decoded format (i.e., the textual interpretation of whichever code was selected from the codelist). In some cases, the code values in the codelist are statistically meaningful, standardized values or scores, which are defined by sponsors or by valid methodologies. The --ORRES variables will contain the decoded format, whereas the --STRESC variables, as well as the --STRESN variables, will contain the standardized values or scores.
Occasionally data that are intended to be numeric are collected with characters attached that cause the character-to- numeric conversion to fail. For example, numeric cell counts in the source data may be specified with a greater than (>) or less than (<) sign attached (e.g., >10,000, <1). These values should have a null result in the --STRESN column, because only numeric values can be represented in the --STRESN field. If it is necessary to provide a numeric equivalent to these results for the purposes of calculation (analysis), this data should be supplied in a SUPP-
- dataset. The supplemental qualifier record should be linked to the record that contains the non-numeric --ORRES value, with a QNAM value of --CALCN, a QLABEL of "Numeric Interpretation for Calculations", and QVAL equal to the value used by the sponsor for calculations. The units of this value should be the same as the standardized units in --STRESU. If the value was not considered numeric for calculation purposes, this type of SUPP-- record should not be provided. Examples of this can be found in Sections 4.5.1.4, Example of Original and Standardized Results and Test Not Done, and 6.3.13, PC PP Cross-Domain Examples.
For numeric non-derived data, --ORRES should be presented at the meaningful precision to which the result was collected. The precision should not be artificially changed due to computer storage considerations.
For numeric derived data, --ORRES and --STRESC should contain the correct number of significant figures based upon the calculation used to derive the value. For example, trailing zeroes should be retained when significant.
Tests Not Done
When an entire examination (e.g., Laboratory Test Results (LB), Clinical Observations (CL)), a group of tests (e.g., hematology or urinalysis), or an individual test (e.g., glucose) is not done for a subject or pool, and this information is explicitly captured with the reason for not collecting the information, record(s) could be created in the dataset to represent this information. A sponsor has 2 options: (1) to submit individual records for each test not done for each subject or pool, or (2) to submit 1 record for each subject or pool for a group of tests that were not done.
For example, if urinalysis is not done, then:
LBTESTCD = "LBALL"
LBTEST = "Laboratory Data"
LBCAT = "URINALYSIS"
LBORRES should be null
LBSTAT should be "NOT DONE"
LBREASND, if collected, might be "no urine sample present"
Example of Original and Standardized Results and Test Not Done
The following examples are meant to illustrate the use of Findings results variables and are not meant as comprehensive domain examples.
Lab Data Example
lb.xpt
Row | STUDYID | DOMAIN | USUBJID | LBSEQ | LBTESTCD | LBTEST | LBCAT | LBORRES | LBORRESU | LBSTRESC | LBSTRESN | LBSTRESU | LBSTAT | LBREASND | LBSPEC | LBMETHOD | LBBLFL | LBDRVFL | LBDTC | LBDY |
1 | LBEX1 | LB | LBEX1- 001 | 1 | GLUC | Glucose | CHEMISTRY | 6.0 | g/mL | 60 | 60 | g/dL | PLASMA | 2010-01- 20T15:00 | 8 | |||||
2 | LBEX1 | LB | LBEX1- 001 | 2 | BACT | Bacteria | URINALYSIS | MODERATE | MODERATE | URINE | 2010-01- 20T18:00 | 8 | ||||||||
3 | LBEX1 | LB | LBEX1- 001 | 3 | ALT | Alanine Aminotransferase | CHEMISTRY | 12.1 | U/L | 12.1 | 12.1 | U/L | PLASMA | 2010-01- 20T15:00 | 8 | |||||
4 | LBEX1 | LB | LBEX1- 001 | 4 | RBC | Erythrocytes | URINALYSIS | TRACE | TRACE | URINE | 2010-01- 20T18:00 | 8 | ||||||||
5 | LBEX1 | LB | LBEX1- 001 | 5 | WBC | Leukocytes | URINALYSIS | 1+ | 1+ | URINE | 2010-01- 20T18:00 | 8 | ||||||||
6 | LBEX1 | LB | LBEX1- 001 | 6 | KETONES | Ketones | URINALYSIS | BLQ | mmol/L | BLQ | mmol/L | URINE | 2010-01- 20T15:00 | 8 | ||||||
7 | LBEX1 | LB | LBEX1- 002 | 1 | HCT | Hematocrit | HEMATOLOGY | NOT DONE | Insufficient Sample | WHOLE BLOOD | 2010-01- 20T15:00 | 8 | ||||||||
8 | LBEX1 | LB | LBEX1- 002 | 2 | MCHC | Ery. Mean Corpuscular HGB Concentration | HEMATOLOGY | 33.8 | g/dL | 33.8 | 33.8 | g/dL | WHOLE BLOOD | Y | 2010-01- 20T15:00 | 8 | ||||
9 | LBEX1 | LB | LBEX1- 003 | 1 | LBALL | Laboratory Data | HEMATOLOGY | NOT DONE | Sample Exhausted | 2010-01- 20T15:00 | 8 | |||||||||
10 | LBEX1 | LB | LBEX1- 004 | 1 | WBC | Leukocytes | HEMATOLOGY | <4000 | /uL | <4000 | /uL | WHOLE BLOOD | 2010-01- 20T15:00 | 8 |
Lab Data Example: SUPPLB
supplb.xpt
Row | STUDYID | RDOMAIN | USUBJID | POOLID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
1 | LBEX1 | LB | LBEX1-004 | LBSEQ | 1 | LBCALCN | Numeric Interpretation for Calculations | 4000 | DERIVED |
Standardizing Units Within a Study
Sponsors may choose to standardize units within a study for a given test (e.g., data are collected from multiple sites, units change across intervals). In this case, a conversion calculation may be required from LBORRESU to LBSTRESU.
The following example shows a case of the Laboratory Test Results (LB) domain where the laboratory test work for a study was performed at different sites, and the unit reported by the sites differed (the original units for serum creatinine include mg/dL, milligrams per deciliter, and umol/L). The sponsor has chosen to standardize the unit for creatinine for the study to mg/dL. So, the LBORRESU field contains the controlled terminology submission values for these units (e.g., "mg/dL," "mg/dL," and "umol/L," respectively), and the LBSTRESU field contains the harmonized unit's controlled terminology submission value (e.g., "mg/dL"). Note that some required and expected LB domain variables have been omitted for example purposes.
lb.xpt
Row | Source Unit | USUBJID | LBTESTCD | LBTEST | LBORRES | LBORRESU | LBSTRESC | LBSTRESN | LBSTRESU | LBNAM |
1 | mg/dL | MOCK_134 | CREAT | Creatinine | 1.0 | mg/dL | 1.0 | 1 | mg/dL | LAB A |
2 | milligrams per deciliter | MOCK_1212 | CREAT | Creatinine | 1.1 | mg/dL | 1.1 | 1.1 | mg/dL | LAB B |
3 | umol/L | MOCK_311 | CREAT | Creatinine | 80 | umol/L | 0.9 | 0.9 | mg/dL | LAB C |
Text Strings That Exceed the Maximum Length for General Observation Class Domain Variables
Because of limitations of SAS v5 transport files, the lengths of data values cannot exceed 200 characters. Because --TEST values may become column labels upon transformation, the SDTM additionally restricts them to 40 characters. Section 4.5.2.1, Test Name (--TEST) Greater Than 40 Characters, provides instructions for handling values of --TEST longer than 40 characters; Section 4.5.2.2, Text Strings Greater than 200 Characters in Other Variables, addresses values of other general-observation class variables longer than 200 characters.
Test Name (--TEST) Greater Than 40 Characters
Sponsors may have test descriptions (--TEST) longer than 40 characters in their operational databases. Because the --TEST variable is meant to serve as a label for --TESTCD when a Findings dataset is transposed to a horizontal format, the length of --TEST is normally limited to 40 characters to conform to the limitations of the SAS v5 transport file format currently used for submission datasets. Therefore, sponsors have the choice to either insert the first 40 characters or a text string abbreviated to 40 characters in --TEST. To address this issue, sponsors may include the full description for these variables:
in the data definition file Origin column for --TEST, provide a link to the source containing the full test description; or
in a PDF document storing full-text descriptions. In such cases, in the data definition file Comments column for --TEST, insert a link to the full-text description in the PDF.
Text Strings Greater than 200 Characters in Other Variables
Some sponsors may have data values longer than 200 characters for some variables. Because of the current requirement for SAS v5 transport file format, it will not be possible to store those long text strings using only 1 variable. Therefore, the SENDIG has defined a convention for storing a long text string by using a combination of the standard domain dataset and the supplemental qualifiers (SUPP--) datasets, which applies to all domains based on a general observation class. Note that the Comments (CO) and Trial Summary (TS) domains are not based on general observation classes and have different rules. See Section 5.2, Comments, and Section 7.6, Trial Summary, for information on handling comment or trial summary text more than 200 characters long.
The first 200 characters of text should be submitted in the standard domain variable, and each additional 200 characters of text should be represented as a record in the SUPP-- dataset (see Section 8, Representing Relationships and Data). In this dataset, the value for QNAM should contain a sequential variable name, which is formed by appending a 1-digit integer, beginning with 1, to the original standard domain variable name. When splitting a text string into several records, the text should be split between words to improve readability.
The following example shows how to use supplemental qualifiers when original result (TFORRES) exceeds 200 characters, which is the SAS limitation for any data field.
In this example, the original result or finding as collected was slightly over 600 characters in length, so the sponsor put the first 200 characters of text in the standard domain variable and dataset (TFORRES in Tumor Findings), the next 200 characters of text as a first supplemental record in the SUPPTF dataset, the next set of 200 characters as a second record in SUPPTF, and the final few characters of text as a third record in the SUPPTF dataset. The QNAM variable has the values TFORRES1, TFORRES2, and TFORRES3 for these 3 records in SUPPTF, respectively, for this particular text string. Sponsors should place the text itself into variable QVAL and the label of the original standard domain variable into variable QLABEL. In this case, IDVAR and IDVARVAL should be used in SUPPTF to relate the associated supplemental text records to the parent record containing the first 200 characters of text in the standard domain.
tf.xpt
Row | STUDYID | DOMAIN | USUBJID | TFSEQ | TFSPID | TFTESTCD | TFTEST | TFORRES | TFSTRESC | TFRESCAT | TFSPEC | TFDTHREL | TFDETECT |
1 | ABC | TF | ABC-560 | 88530 | MASS 2 | TUMEX | Tumor Examination | Progressive nephropathy shown by a thickening of the basement membrane, some tubules have multiple layers of regenerative epithelium, others have flattened, atrophic epithelium. There is prominent | CARCINOMA, BASAL CELL, MALIGNANT | MALIGNANT | KIDNEY | Y | 650 |
supptf.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
1 | ABC | TF | ABC-560 | TFSEQ | 88530 | TFORRES1 | Original Result or Finding as Collected1 | interstitial fibrosis and inflammatory infiltrates and dilated tubules filled with protein casts. Pigment and mineralization is seen in tubular epithelial cells. The glomerulus shows an increased | COLLECTED |
2 | ABC | TF | ABC-560 | TFSEQ | 88530 | TFORRES2 | Original Result or Finding as Collected2 | mesangial proliferation with basement membrane thickening and adhesions are present between the glomerular tuft and capsular wall. There is a slight increase in the size and number of parietal cells | COLLECTED |
3 | ABC | TF | ABC-560 | TFSEQ | 88530 | TFORRES3 | Original Result or Finding as Collected3 | in Bowman's capsule. | COLLECTED |
Biological Significance for Findings Observation Class Data
For assessments of biological significance when the overall interpretation is a record in the domain, use the supplemental qualifier (SUPP--) record (with QNAM
= --BIOSIG) linked to the record that contains the overall interpretation or a particular result. An example would be a QNAM value of LBBIOSIG in SUPPLB with a value of "Y", indicating that a lab result for albumin of 30 mg/mL was biologically significant.
It should be noted that biological significance is different from the concepts of normal and abnormal, which are generally submitted in --ORRES.
Supplemental Reason Variables
The SDTM general observation classes include the --REASND variable to submit the reason an observation was not collected. However, sponsors sometimes collect the reason that something was done. For the Interventions general observation class, --INDC and --ADJ are available to indicate the reason for the intervention or for the dose adjustment. For the Findings general observation class, if the sponsor collects the reason for performing a test or examination, it should be placed in the SUPP-- dataset as described in Section 8.3, Supplemental Qualifiers - SUPP-- Datasets. The standard SUPP-- QNAM value of --REAS should be used as described in Section 8, Representing Relationships and Data.
For example, if the sponsor collects the reason that extra lab tests were done, the SUPP-- record might be populated as follows.
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL |
1 | 12345 | LB | 99-123 | LBSEQ | 3 | LBREAS | Reason Test or Examination was Performed | ORIGINAL SAMPLE LOST |
For a result variable (e.g., --ORRES) whose origin is defined as COLLECTED in the define file, there may be the occasional need to derive other records (e.g., mean or ratio). In such a case, --DRVFL would have a value of "Y".
The following table shows an abbreviated example of some blood pressure readings (Cardiovascular Test Results domain), highlighting the use of --DRVFL to indicate that a record in the CV domain was derived from other records also in the domain.
cv.xpt
Row | CVTEST | CVORRES | CVDRVFL | CVDTC |
1 | Systolic Blood Pressure | 154 | 2010-01-19T09:52 | |
2 | Systolic Blood Pressure | 149 | 2010-01-19T09:54 | |
3 | Systolic Blood Pressure | 153 | 2010-01-19T09:55 | |
4 | Systolic Blood Pressure | 152 | Y | 2010-01-19 |
The following table shows collected protein and creatinine chemistry lab tests.
lb.xpt
Row | STUDYID | DOMAIN | USUBJID | LBSEQ | LBTESTCD | LBTEST | LBCAT | LBSCAT | LBORRES | LBORRESU | LBSTRESC | LBSTRESN | LBSTRESU | LBSPEC | LBDRVFL | LBDTC | LBDY |
1 | ABC | LB | ABC- 1001 | 303 | PROT | Protein | Chemistry | 6.3 | mg/dL | 6.3 | 6.3 | mg/dL | SERUM | 2011-01- 09T12:51:00 | 9 | ||
2 | ABC | LB | ABC- 1001 | 307 | CREAT | Creatinine | Chemistry | 0.5 | mg/dL | 0.5 | 0.5 | mg/dL | SERUM | 2011-01- 09T12:51:00 | 9 | ||
3 | ABC | LB | ABC- 1001 | 5550 | PROTCRT | Protein/Creatinine | Chemistry | 12.6 | RATIO | 12.6 | 12.6 | RATIO | SERUM | Y | 2011-01-09 | 9 | |
4 | ABC | LB | ABC- 1001 | 5550 | PROTCRT | Protein/Creatinine | Chemistry | 12.6 | RATIO | 12.6 | 12.6 | RATIO | SERUM | 2011-01- 09T12:51:00 | 9 |
Note that a sponsor may also set --GRPID to more explicitly define the relationship between each derived record and the records from which it was sourced. This practice would be especially important in the case of multiple derived records in a domain for the same subject (e.g., 2 baseline averages).
Models for Special-purpose Domains
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
DOMAIN | Domain Abbreviation | Char | DM | Identifier | Two-character abbreviation for the domain. | Req |
USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | |
SUBJID | Subject Identifier for the Study | Char | Topic | Subject (i.e., Animal) identifier used within the study. | Req | |
RFSTDTC | Subject Reference Start Date/Time | Char | ISO 8601 | Record Qualifier | Reference start date/time for the subject in ISO 8601 format. Usually equivalent to date/time when subject was first exposed to study treatment. Study day calculation (the --DY variable) in all domains will be based on this date. The sponsor must define what collected date is used to populate RFSTDTC in the data definition file. | Req |
RFENDTC | Subject Reference End Date/Time | Char | ISO 8601 | Record Qualifier | Reference end date/time for the subject in ISO 8601 format. Usually equivalent to the date/time when the subject was determined to have left the study. The sponsor must define what collected date is used to populate RFENDTC in the data definition file. | Exp |
RFXSTDTC | Date/Time of First Study Treatment | Char | ISO 8601 | Record Qualifier | First date/time of exposure to any protocol-specified treatment or therapy, equal to the earliest value of EXSTDTC. Note: Absolute first. | Perm |
RFXENDTC | Date/Time of Last Study Treatment | Char | ISO 8601 | Record Qualifier | Last date/time of exposure to any protocol-specified treatment or therapy, equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not collected or is missing). Note: Absolute last | Perm |
SITEID | Study Site Identifier | Char | Record Qualifier | Unique identifier for a study site within a submission. Use only if subjects are housed at different sites. | Perm | |
BRTHDTC | Date/Time of Birth | Char | ISO 8601 | Record Qualifier | Date/Time of birth of the subject, in ISO 8601 format. | Perm |
AGE | Age | Num | Record Qualifier | May be derived (RFSTDTC – BRTHDTC), but BRTHDTC may not be available in all cases. Age may also be collected. | Perm | |
AGETXT | Age Range | Char | number-number | Record Qualifier | Used when the age is a range and the exact birthdate is not known. This variable is a character field for the purposes of defining age ranges, e.g., if the information available for the age of the subject is 6-8 and AGEU is WEEKS. Populate only when BRTHDTC or AGE is not specified. The format for AGETXT is "number-number" (e.g., 6-8). | Perm |
AGEU | Age Unit | Char | Variable Qualifier | Units associated with AGE and AGETXT. | Exp |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
SEX | Sex | Char | Record Qualifier | The sex of the subject. | Req | |
SPECIES | Species | Char | Record Qualifier | If this variable is excluded in the DM domain, the information must be present at a higher level (either Trial Sets or Trial Summary). | Perm | |
STRAIN | Strain/Substrain | Char | Record Qualifier | Used to identify the vendor-supplied strain, substrain, or breed designation for the test system under study. It may combine the background strain, substrain, and associated genetic modifications as supplied by the vendor (e.g., C57BL/6, A/J, B6.129-Pparg<tm2Rev>/J, FISCHER 344, SPRAGUE-DAWLEY IGS, WISTAR Kyoto, BEAGLE, CYNOMOLGUS, and CHIMPANZEE). The SEND Controlled Terminology codelist consists of commonly used wild type strains. It is extensible to accommodate strains not listed and genetically modified substrains. If this variable is excluded in the DM domain, the information must be present at a higher level (either Trial Sets or Trial Summary). Country of origin for non-human primates should not go into STRAIN. In general, details related to coat color (e.g., White and Red designations for New Zealand Rabbits) should not go into STRAIN. | Perm | |
SBSTRAIN | Strain/Substrain Details | Char | Record Qualifier | Free-text field that allows the sponsor to enter further details qualifiying the SPECIES and/or STRAIN, depending on the level to which these variables were defined. Examples include the description of a specific genetic alteration, country of origin for non-human primates, details related to coat color (e.g., White and Red designations for New Zealand Rabbits), and important animal husbandry information (e.g., SPF, BR, VAF). | Perm | |
ARMCD | Planned Arm Code | Char | Record Qualifier | Short name for ARM (may be up to 20 characters) used for sorting and programming. Should be populated when Arms have been defined in the TA domain. | Exp | |
ARM | Description of Planned Arm | Char | Synonym Qualifier | Descriptive name given to a specific Trial Arm (e.g., Low Dose, Mid Dose, 10 mg/kg/day dose, Third Arm) to which the subject was assigned. | Perm | |
SETCD | Set Code | Char | Record Qualifier | Short name of a specific Trial Set to which the subject was assigned, as defined by the sponsor. Maximum of 8 characters. This represents the Trial Set for which parameters are being submitted. | Req |
Assumptions for (DM) Demographics Domain Model
Subject identification: It is presumed that every subject (i.e., animal) in a study will have a subject identifier (SUBJID). In some cases, a subject may be included in more than 1 study within a submission, and, more commonly, subjects from different studies may have the same subject identifier. To identify a subject uniquely across a submission, a unique identifier (USUBJID) should be assigned and included in all subject-related datasets in the submission.
Arm/treatment identification: When a sponsor is submitting study design information, the values of ARMCD and ARM should be identical to the values defined for that subject in the Subject Elements (SE) dataset. The assignment of values should be consistent, if possible, within a submission.
When additional information is reported about the subjects, sponsors should place this information in the Subject Characteristics (SC) domain, adding the specific variable as a value in SCTEST. Study design information that does not vary on an individual subject level should be placed in the Trial Sets (TX) table.
BRTHDTC, AGE, and AGETXT: These variables represent 3 levels of precision for the age of the subject, and they should be used according to the information available.
AGE and AGETXT should never both be populated for the same subject. AGEU refers to whichever variable is used.
If information is available about the time of birth for the subject, it should be presented in the variable BRTHDTC in ISO 8601 format, even if this is only partial information (not a complete date of birth). Section 4.4.2, Date/Time Precision, discusses how to represent date/time precision in ISO 8601.
Data in BRTHDTC should never be derived from another variable. Either this information is collected or this variable should be blank.
If a specific age for the subject is known, but no information regarding date/time of birth is available, then AGE and AGEU should be populated, using the most descriptive/precise unit for the data (e.g., 1 year, 2 months would be AGE = "14" and AGEU = "MONTHS").
Sponsors may choose to derive AGE and AGEU using an algorithm involving BRTHDTC and RFSTDTC. Sponsors should indicate how AGE was populated in the define file comments.
If only an approximate age is known (e.g., 6-8 weeks), then use AGETXT in conjunction with AGEU (e.g., AGETXT = "6-8" and AGEU = "WEEKS"). The format for AGETXT is number-number (e.g., "6-8").
RFSTDTC, RFENDTC, and BRTHDTC represent date/time values, but they are considered to have a record qualifier role in DM. They are not considered to be timing variables as described in SDTM v1.5, Section 2.2.6, because they are not intended for use in the general observation classes. The subject may have records in other domains with a date/time prior to RFSTDTC and after the RFENDTC.
SPECIES and STRAIN: These variables are permissible and should be used only if different species or strains are used during 1 study. If all the subjects in 1 study are of the same species, strain, and substrain, then this information is collected in the Trial Summary (TS) table. TX can have multiple species and/or strains if they are different by set.
The SETCD variable is to be used by the sponsor to uniquely identify all distinct "groups" or "trial sets." A trial set is a collection of subjects that have a common set of parameters defined in the protocol, where those parameters include experimental parameters, treatment strategies, inherent characteristics (e.g., strain) parameters, and/or sponsor-defined attributes (e.g., control group designation). In general, if a distinction between arms does not cause the subjects to be summarized or grouped independently, then the arms should not be reflected as a separate trial set. A subject may belong to 1 and only 1 trial set. For further explanation of SETCD, see Section 7.4, Trial Sets.
ARM: An arm is a planned path through a study. This path covers the entire time of the study. The group of subjects assigned to an arm is also often colloquially called an "arm." The group of subjects assigned to an arm is also often called a "treatment group," although it is not necessarily a treatment group. The same arm can be used to separate subjects into different satellites. For example, use SETCD for assigning main study subjects and TK study subjects. See Section 7.4, Trial Sets, for further details.
Examples for Demographics (DM) Domain Model
The following examples illustrate typical scenarios in the DM domain. Example 1 is a general DM example showing a study of 6 animals with different arms recorded.
Example 1: General Demographics
The animal number given in this study is the SUBJID. In this example, STUDYID and SUBJID have been concatenated to create the USUBJID. This is to ensure that this particular animal is referred to in a unique way throughout an entire submission, which one might expect to be composed of several studies where each study contains an animal number with SUBJID = "1." Note: USUBJID does not need necessarily to be created by concatenating STUDYID and SUBJID, but it must be a unique identifying value for a subject across all studies within the submission.
This is a simple study where ARMCD represents dose groups, which is not always the case. This study has 3 groups (ARMCD values 1-3): ARMCD = "1" is the control animals, ARMCD = "2" is the low-dose animals, and ARMCD = "3" is the high-dose animals.
The actual birth dates of the animals were recorded; therefore, the age of the animals was calculated and recorded.
Row | STUDYID | DOMAIN | USUBJID | SUBJID | RFSTDTC | RFENDTC | BRTHDTC | AGE | AGEU | SEX | ARMCD | ARM | SETCD |
1 | ABC | DM | ABC-1 | 1 | 2006-01-01 | 2006-03-10 | 2005-12-01 | 31 | DAYS | M | 1 | Control | 1 |
2 | ABC | DM | ABC-2 | 2 | 2006-01-01 | 2006-02-28 | 2005-12-01 | 31 | DAYS | M | 1 | Control | 1 |
3 | ABC | DM | ABC-3 | 3 | 2006-01-01 | 2006-03-19 | 2005-12-01 | 31 | DAYS | M | 2 | Low | 2 |
4 | ABC | DM | ABC-4 | 4 | 2006-01-01 | 2006-03-10 | 2005-12-01 | 31 | DAYS | F | 2 | Low | 2 |
5 | ABC | DM | ABC-5 | 5 | 2006-01-01 | 2006-03-31 | 2005-12-15 | 17 | DAYS | F | 3 | High | 3 |
6 | ABC | DM | ABC-6 | 6 | 2006-01-01 | 2006-04-05 | 2005-12-16 | 16 | DAYS | F | 3 | High | 3 |
In this example, the variable "SPECIES" has been omitted because this information is within the Trial Summary (TS) domain. Rows 1-6: Show demographics records for 6 subjects. Note that the subjects possess birthdates (BRTHDTC) and ages (AGE, AGEU). dm.xpt
Example 2: Unknown Birth Date
In this example, the exact birth date of the animal is not known, but there is an age range, so the AGETXT in conjunction with the AGEU is used. This study has some animals where the sex of the animals is either unknown or undifferentiated.
dm.xpt
Row | STUDYID | DOMAIN | USUBJID | SUBJID | RFSTDTC | RFENDTC | AGETXT | AGEU | SEX | ARMCD | ARM | SETCD |
1 | DCB | DM | DCB-1 | 1 | 2006-01-01 | 2006-03-10 | 2-4 | WEEKS | U | 1 | Low | 1 |
2 | DCB | DM | DCB-2 | 2 | 2006-01-01 | 2006-03-10 | 2-4 | WEEKS | UN | 2 | High | 2 |
Example 3: Species, Strains, and Substrains
dm.xpt
Row | STUDYID | DOMAIN | USUBJID | SUBJID | RFSTDTC | RFENDTC | AGETXT | AGEU | SEX | SPECIES | STRAIN | SBSTRAIN | ARMCD | SETCD |
1 | ABC | DM | ABC-101 | 101 | 2006-03- 01 | 2006-04- 16 | 8-9 | WEEKS | M | RAT | FISCHER 344 | Surgically ovariectomized | 1 | RFIS2 |
2 | ABC | DM | ABC-102 | 102 | 2006-03- 01 | 2006-04- 16 | 8-9 | WEEKS | M | RAT | FISCHER 344 | Surgically ovariectomized | 1 | RFIS2 |
3 | ABC | DM | ABC-103 | 103 | 2006-03- 01 | 2006-04- 16 | 8-9 | WEEKS | M | RAT | ZUCKER | Zuker Diabetic Fatty; obese; Type 2 diabetic; ZDF.GmiCrl-fa/fa | 2 | RZDF3 |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
DOMAIN | Domain Abbreviation | Char | CO | Identifier | Two-character abbreviation for the domain. | Req |
RDOMAIN | Related Domain Abbreviation | Char | Record Qualifier | Domain abbreviation of the parent record(s). Null for comments collected as a general comment or additional information. | Exp | |
USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Either USUBJID or POOLID must be populated unless the record contains a study comment unrelated to a USUBJID or POOLID. | Exp | |
POOLID | Pool Identifier | Char | Identifier | Identifier used for pooled subjects to assign a single result to multiple subjects. Either USUBJID or POOLID must be populated unless the record contains a study comment unrelated to a USUBJID or POOLID. | Perm | |
COSEQ | Sequence Number | Num | Identifier | The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record. | Req | |
IDVAR | Identifying Variable | Char | Record Qualifier | Variable in the parent dataset that identifies the record(s) to which the comment applies, which is contained in IDVAR. Examples: BWSEQ or CLGRPID. Used only when individual comments are related to domain records. | Exp | |
IDVARVAL | Identifying Variable Value | Char | Record Qualifier | Value of identifying variable of the parent record(s). Used only when individual comments are related to domain records. Cannot be populated if IDVAR is null. | Exp | |
COREF | Comment Reference | Char | Record Qualifier | Sponsor-defined reference associated with the comment. May be the logbook page number, name (e.g., Logbook), or a combination of information that identifies the reference (e.g., Logbook, page 650, Day 28, morning). | Perm | |
COVAL | Comment | Char | Topic | The text of the comment. Text over 200 characters can be added to additional columns COVAL1- COVALn. See Assumption 4 in Section 5.2.1.1. | Req | |
COEVAL | Evaluator | Char | Record Qualifier | Used to describe the originator of the comment. Examples: TECHNICIAN, STUDY DIRECTOR, VET. | Perm | |
CODTC | Date/Time of Comment | Char | ISO 8601 | Timing | Date/Time of the comment, in ISO 8601 format. May be null if this is a child record of another domain or if the comment date was not collected. In all other cases, this represents the date/time of the comment in ISO 8601 format. | Exp |
CODY | Study Day of Comment | Num | Timing | Study day of the comment, in integer days. May be null if this is a child record of another domain or if the comment date was not collected. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm |
Assumptions for Comments (CO) Domain Model
The Comments special-purpose domain provides a solution for submitting free-text comments related to data in 1 or more SEND domains. Comments are generally not responses to specific questions; instead, they usually consist of voluntary, free-text, or unsolicited observations.
When RDOMAIN and USUBJID are not populated, it is assumed that a comment pertains to a study as a whole.
The CO dataset accommodates 3 sources of comments:
Related to a specific parent record or group of parent records, in which case the value of the variable RDOMAIN is set to the DOMAIN code of the parent record(s), and the variables IDVAR and IDVARVAL are populated with the key variable name and value of the parent record(s). Assumptions for populating IDVAR and IDVARVAL are further described in Section 8.2, Relating Records - RELREC.
Unrelated to a specific domain or parent record(s), in which case the values of the variables RDOMAIN, IDVAR, and IDVARVAL are null. CODTC should be populated if captured. (See Example 1, rows 8-9.)
Related to a domain but not to specific parent record(s), in which case the value of the variable RDOMAIN is set to the DOMAIN code of the parent domain and the variables USUBJID, IDVAR, and IDVARVAL are null. CODTC should be populated if captured. (See Example 1, row 10.)
When the comment text is longer than 200 characters, the first 200 characters of the comment will be in COVAL, the next 200 in COVAL1, and additional text represented as needed to COVALn. (See Example 1, row 7). Note: When using COVAL1-COVALn, the variable label should match the corresponding variable name (e.g., Comment1, Comment2).
See Section 8.2, Relating Records - RELREC, for additional information about how to relate comments to parent records.
The following identifier and timing variables are permissible and may be added as appropriate when comments are not related to other domain records: COGRPID, COREF, COREFID, COSPID, TAETORD, CODY, COTPT, COTPTNUM, COELTM, COTPTREF, and CORFTDTC.
Examples for Comments (CO) Domain Model
Example 1
co.xpt
Row | STUDYID | DOMAIN | RDOMAIN | USUBJID | COSEQ | IDVAR | IDVARVAL | COREF | COVAL | COVAL1 | COVAL2 | COEVAL | CODTC | CODY |
1 | ABC123 | CO | BW | ABC123- 1001 | 1 | BWSEQ | 1 | animal reweighed | TECH | |||||
2 | ABC123 | CO | LB | ABC123- 1001 | 3 | LBSEQ | 2516 | sample taken peri-mortem | ||||||
3 | ABC123 | CO | CL | ABC123- 1001 | 4 | CLSEQ | 5642 | during mortality check | ||||||
4 | ABC123 | CO | CL | ABC123- 1003 | 5 | CLSEQ | 7541 | fur wet pre-rx | ||||||
5 | ABC123 | CO | FW | ABC123- 1001 | 6 | FWSEQ | 6542 | 100g warm water add to 400g of pmi certified 5007 | ||||||
6 | ABC123 | CO | FW | ABC123- 1002 | 7 | FWSEQ | 5621 | food supplement | ||||||
7 | ABC123 | CO | TF | ABC123- 1002 | 8 | TFSEQ | 88530 | Interstitial fibrosis and inflammatory infiltrates and dilated tubules filled with protein casts. Pigment and mineralization is seen in tubular epithelial cells. The glomerulus shows an increased | mesangial proliferation with basement membrane thickening and adhesions are present between the glomerular tuft and capsular wall. There is a slight increase in the size and number of parietal cells | in Bowman's capsule. | ||||
8 | ABC123 | CO | 11 | HVAC failure so the animals didn't have cooling | TECH | 2006-07- 19T08:30 | 84 | |||||||
9 | ABC123 | CO | 12 | Logbook page 650 | Comment for logbook. | STUDY DIRECTOR | 2006-07- 19 | 84 | ||||||
10 | ABC123 | CO | BW | 13 | The scale was not calibrated as scheduled in week 2 | TECH | 2007-05- 11 | 15 |
An element is a basic building block in the trial design. It involves administering a planned intervention, which may be treatment or no treatment, during a period of time. The Subject Elements (SE) domain contains the design elements that each subject actually experienced. As a reference, the Trial Elements (TE), Trial Arms (TA), and Trial Sets (TX) datasets in the Trial Design Model describe and use the various planned design elements (see Section 7, Trial Design Model Datasets) that subjects may experience. The subject's assignment to an arm is reported in the ARM and ARMCD variables in the Demographics (DM) domain.
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
DOMAIN | Domain Abbreviation | Char | SE | Identifier | Two-character abbreviation for the domain. | Req |
USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | |
SESEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a USUBJID within a domain. May be any valid number. | Req | |
ETCD | Element Code | Char | Topic | ETCD (the companion to ELEMENT) is limited to 8 characters and does not have special character restrictions. | Req | |
ELEMENT | Description of Element | Char | Synonym Qualifier | The name of the Element.. | Perm | |
SESTDTC | Start Date/Time of Element | Char | ISO 8601 | Timing | Start date/time for an Element for each subject, in ISO 8601 format. | Req |
SEENDTC | End Date/Time of Element | Char | ISO 8601 | Timing | End date/time for an Element for each subject, in ISO 8601 format. | Exp |
SEUPDES | Description of Unplanned Element | Char | Synonym Qualifier | Description of what happened to the subject during an unplanned Element. Used only if ETCD has the value of UNPLAN. | Perm |
Assumptions for Subject Elements (SE) Domain Model
The Subject Elements domain allows the submission of data on the individual experience: the actual timing and sequence of elements a subject experienced. See Section 7.2, Trial Elements, and Section 7.3, Trial Arms; the TE and TA datasets define a study's planned elements and describe the planned sequences of elements for the arms of the study. There are, by definition, no time gaps between elements; therefore, the value of SEENDTC for one element will always be immediately before or the same as the value of SESTDTC for the next element. Each element continues until the time at which the next element begins, and a subject must be in only 1 element at a time.
For any particular subject, the dates in the SE table are the dates when the transition events identified in the TE table occurred.
If the start date/time of an element was not collected directly, the method used to infer the element start date/time should be explained in the Comments column of the data definition file.
If the sponsor decides that the subject's experience for a particular period of time cannot be represented with one of the planned elements, then that period of time should be represented as an unplanned element.
For unplanned elements, ETCD should be populated with "UNPLAN", ELEMENT should be left blank, and SEUPDES should be populated with a description of the unplanned element.
With the exception of unplanned elements, the values of ETCD used in this domain should match values for the same element in the TE dataset.
The values of SESTDTC provide the chronological order of the actual subject elements. SESEQ should be assigned to be consistent with the chronological order. Note that the requirement that SESEQ be consistent with chronological order is more stringent than in most other domains, where -
-SEQ values need only be unique within subject.
Examples for Subject Elements (SE) Domain Model
Example 1: Parallel Design
In this example, subjects ABC1-001, ABC1-021, and ABC1-041 all experienced their planned sequence of elements. The SE dataset documents the start and end dates of each element.
se.xpt
Row | STUDYID | DOMAIN | USUBJID | SESEQ | ETCD | ELEMENT | SESTDTC | SEENDTC |
1 | ABC1 | SE | ABC1-001 | 1 | SCRN | Screen | 2008-01-08 | 2008-01-14 |
2 | ABC1 | SE | ABC1-001 | 2 | GP 01 | Vehicle Control | 2008-01-15 | 2008-01-27 |
3 | ABC1 | SE | ABC1-021 | 1 | SCRN | Screen | 2008-01-08 | 2008-01-14 |
4 | ABC1 | SE | ABC1-021 | 2 | GP 02 | 100 mg/kg Drug A | 2008-01-15 | 2008-01-27 |
5 | ABC1 | SE | ABC1-041 | 1 | SCRN | Screen | 2008-01-08 | 2008-01-14 |
6 | ABC1 | SE | ABC1-041 | 2 | GP 03 | 500 mg/kg Drug A | 2008-01-15 | 2008-01-27 |
The following table is the corresponding Trial Arms (TA) dataset outlining the planned arms and elements for the same study. This is provided to assist with understanding how the actual experienced elements (SE dataset) relate to the planned arms defined here.
ta.xpt
Row | STUDYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT | TABRANCH | EPOCH |
1 | ABC1 | TA | 01 | Control | 1 | SCRN | Screen | Randomized to Group 01 | Screen |
2 | ABC1 | TA | 01 | Control | 2 | GP 01 | Vehicle Control | Treatment | |
3 | ABC1 | TA | 02 | 100 mg/kg | 1 | SCRN | Screen | Randomized to Group 02 | Screen |
4 | ABC1 | TA | 02 | 100 mg/kg | 2 | GP 02 | 100 mg/kg Drug A | Treatment | |
5 | ABC1 | TA | 03 | 500 mg/kg | 1 | SCRN | Screen | Randomized to Group 03 | Screen |
6 | ABC1 | TA | 03 | 500 mg/kg | 2 | GP 03 | 500 mg/kg Drug A | Treatment |
Note: This is a simple design where ARMCD relates directly to dose groups. In more complex designs, a separation between arms and groups may be required in naming conventions (e.g., "Randomized to Treatment 1").
Example 2: Parallel Design
In this example, all of the subjects experienced their planned sequence of elements. The SE dataset documents their start and end date/times for each element.
se.xpt
Row | STUDYID | DOMAIN | USUBJID | SESEQ | ETCD | ELEMENT | SESTDTC | SEENDTC |
1 | CDF2 | SE | CDF2-001 | 1 | PRETEST | Screen | 2008-01-08 | 2008-01-14T07:00 |
2 | CDF2 | SE | CDF2-001 | 2 | TREATA | Vehicle Control | 2008-01-14T07:00 | 2008-01-27T09:00 |
3 | CDF2 | SE | CDF2-001 | 3 | RECOVERY | Rest | 2008-01-27T09:00 | 2008-02-02T07:00 |
4 | CDF2 | SE | CDF2-010 | 1 | PRETEST | Screen | 2008-01-08 | 2008-01-14T07:00 |
Row | STUDYID | DOMAIN | USUBJID | SESEQ | ETCD | ELEMENT | SESTDTC | SEENDTC |
5 | CDF2 | SE | CDF2-010 | 2 | TREATB | 100 mg/kg Drug A | 2008-01-14T07:00 | 2008-01-27T09:30 |
6 | CDF2 | SE | CDF2-010 | 3 | RECOVERY | Rest | 2008-01-27T09:30 | 2008-02-02T07:00 |
7 | CDF2 | SE | CDF2-020 | 1 | PRETEST | Screen | 2008-01-08 | 2008-01-14T07:00 |
8 | CDF2 | SE | CDF2-020 | 2 | TREATC | 300 mg/kg Drug A | 2008-01-14T07:00 | 2008-01-27T10:30 |
9 | CDF2 | SE | CDF2-020 | 3 | RECOVERY | Rest | 2008-01-27T10:30 | 2008-02-02T07:00 |
10 | CDF2 | SE | CDF2-030 | 1 | PRETEST | Screen | 2008-01-08 | 2008-01-14T07:00 |
11 | CDF2 | SE | CDF2-030 | 2 | TREATD | 900 mg/kg Drug A | 2008-01-14T07:00 | 2008-01-27T10:30 |
12 | CDF2 | SE | CDF2-030 | 3 | RECOVERY | Rest | 2008-01-27T10:30 | 2008-02-02T07:00 |
Note: The exact time for the start of the screen element was not recorded. Therefore, the value of SESTDTC for the screen element only reflects the date (without the exact time) the element commenced.
ta.xpt
Row | STUDYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT | TABRANCH | EPOCH |
1 | CDF2 | TA | 1 | Control | 1 | PRETEST | Screen | Randomized to Treatment 1 | Screen |
2 | CDF2 | TA | 1 | Control | 2 | TREATA | Vehicle Control | Treatment | |
3 | CDF2 | TA | 1 | Control | 3 | RECOVERY | Rest | Rest | |
4 | CDF2 | TA | 2 | Low | 1 | PRETEST | Screen | Randomized to Treatment 2 | Screen |
5 | CDF2 | TA | 2 | Low | 2 | TREATB | 100 mg/kg Drug A | Treatment | |
6 | CDF2 | TA | 2 | Low | 3 | RECOVERY | Rest | Rest | |
7 | CDF2 | TA | 3 | Mid | 1 | PRETEST | Screen | Randomized to Treatment 3 | Screen |
8 | CDF2 | TA | 3 | Mid | 2 | TREATC | 300 mg/kg Drug A | Treatment | |
9 | CDF2 | TA | 3 | Mid | 3 | RECOVERY | Rest | Rest | |
10 | CDF2 | TA | 4 | High | 1 | PRETEST | Screen | Randomized to Treatment 4 | Screen |
11 | CDF2 | TA | 4 | High | 2 | TREATD | 900 mg/kg Drug A | Treatment | |
12 | CDF2 | TA | 4 | High | 3 | RECOVERY | Rest | Rest |
Example 3: Mis-dosing of an Animal
In this example, subject CDF2-020 received an incorrect dose on 2008-01-20. This example should be understood in the context of the TA dataset provided in Example 2.
se.xpt
Row | STUDYID | DOMAIN | USUBJID | SESEQ | ETCD | ELEMENT | SESTDTC | SEENDTC | SEUPDES |
1 | CDF2 | SE | CDF2-001 | 1 | PRETEST | Screen | 2008-01-08 | 2008-01-14T07:00 | |
2 | CDF2 | SE | CDF2-001 | 2 | TREATA | Vehicle Control | 2008-01-14T07:00 | 2008-01-27T09:00 | |
3 | CDF2 | SE | CDF2-001 | 3 | RECOVERY | Rest | 2008-01-27T09:00 | 2008-02-02T07:00 | |
4 | CDF2 | SE | CDF2-010 | 1 | PRETEST | Screen | 2008-01-08 | 2008-01-14T07:00 |
Row | STUDYID | DOMAIN | USUBJID | SESEQ | ETCD | ELEMENT | SESTDTC | SEENDTC | SEUPDES |
5 | CDF2 | SE | CDF2-010 | 2 | TREATB | 100 mg/kg Drug A | 2008-01-14T07:00 | 2008-01-27T9:30 | |
6 | CDF2 | SE | CDF2-010 | 3 | RECOVERY | Rest | 2008-01-27T09:30 | 2008-02-02T07:00 | |
7 | CDF2 | SE | CDF2-020 | 1 | PRETEST | Screen | 2008-01-08 | 2008-01-14T07:00 | |
8 | CDF2 | SE | CDF2-020 | 2 | TREATC | 300 mg/kg Drug A | 2008-01-14T07:00 | 2008-01-20T10:30 | |
9 | CDF2 | SE | CDF2-020 | 3 | UNPLAN | 2008-01-20T10:30 | 2008-01-21T07:00 | Misdosed with 900 mg/kg A | |
10 | CDF2 | SE | CDF2-020 | 4 | TREATC | 300 mg/kg Drug A | 2008-01-21T07:00 | 2008-01-27T10:30 | |
11 | CDF2 | SE | CDF2-020 | 5 | RECOVERY | Rest | 2008-01-27T10:30 | 2008-02-02T07:00 | |
12 | CDF2 | SE | CDF2-030 | 1 | PRETEST | Screen | 2008-01-08 | 2008-01-14T07:00 | |
13 | CDF2 | SE | CDF2-030 | 2 | TREATD | 900 mg/kg Drug A | 2008-01-14T07:00 | 2008-01-27T10:30 | |
14 | CDF2 | SE | CDF2-030 | 3 | RECOVERY | Rest | 2008-01-27T10:30 | 2008-02-02T07:00 | |
15 | CDF2 | SE | CDF2-040 | 1 | PRETEST | Screen | 2008-01-08 | 2008-01-14T07:00 | |
16 | CDF2 | SE | CDF2-040 | 2 | TREATE | Positive Control Drug XY | 2008-01-14T07:00 | 2008-01-27T10:30 |
Example 4: High Dose Changed from 900 mg/kg to 700 mg/kg
In this example, the high-dose group originally scheduled to get 900 mg/kg was intentionally changed to 700 mg/kg after 1 week of the study. Prior to this change, a protocol amendment was created that altered the plan; therefore, this element would appear in TA, Trial Elements (TE), and SE.
se.xpt
Row | STUDYID | DOMAIN | USUBJID | SESEQ | ETCD | ELEMENT | SESTDTC | SEENDTC |
1 | CDF2 | SE | CDF2-001 | 1 | PRETEST | Screen | 2008-01-08 | 2008-01-14T07:00 |
2 | CDF2 | SE | CDF2-001 | 2 | TREATA | Vehicle Control | 2008-01-14T07:00 | 2008-01-27T09:00 |
3 | CDF2 | SE | CDF2-001 | 3 | RECOVERY | Rest | 2008-01-27T09:00 | 2008-02-02T07:00 |
4 | CDF2 | SE | CDF2-010 | 1 | PRETEST | Screen | 2008-01-08 | 2008-01-14T07:00 |
5 | CDF2 | SE | CDF2-010 | 2 | TREATB | 100 mg/kg Drug A | 2008-01-14T07:00 | 2008-01-27T09:30 |
6 | CDF2 | SE | CDF2-010 | 3 | RECOVERY | Rest | 2008-01-27T09:30 | 2008-02-02T07:00 |
7 | CDF2 | SE | CDF2-020 | 1 | PRETEST | Screen | 2008-01-08 | 2008-01-14T07:00 |
8 | CDF2 | SE | CDF2-020 | 2 | TREATC | 300 mg/kg Drug A | 2008-01-14T07:00 | 2008-01-27T10:30 |
9 | CDF2 | SE | CDF2-020 | 3 | RECOVERY | Rest | 2008-01-27T10:30 | 2008-02-02T07:00 |
10 | CDF2 | SE | CDF2-030 | 1 | PRETEST | Screen | 2008-01-08 | 2008-01-14T07:00 |
11 | CDF2 | SE | CDF2-030 | 2 | TREATD | 900 mg/kg Drug A | 2008-01-14T07:00 | 2008-01-21T07:00 |
12 | CDF2 | SE | CDF2-030 | 3 | TREATD2 | 700 mg/kg Drug A | 2008-01-21T07:00 | 2008-01-27T09:30 |
13 | CDF2 | SE | CDF2-030 | 4 | RECOVERY | Rest | 2008-01-27T09:30 | 2008-02-02T07:00 |
14 | CDF2 | SE | CDF2-040 | 1 | PRETEST | Screen | 2008-01-08 | 2008-01-14T07:00 |
15 | CDF2 | SE | CDF2-040 | 2 | TREATE | Positive Control Drug XY | 2008-01-14T07:00 | 2008-01-27T10:30 |
Example 5: Animal Skipping an Element
The ARMCD variable in the Demographics (DM) domain can be used with the TA table to determine the planned elements for USUBJID CDF2-020. The SE domain is intended to reflect the actual experiences of the subject, not variations from plan. What is important to note in this example is that a missed planned
element does not result in an unplanned entry ("UNPLAN" in ETCD). Because subject CDF2-020 went directly from one planned element to a subsequent planned element (skipping a planned element in between), there is no entry to reflect the missed element. Specifically, subject CDF2-020 did not experience any unplanned elements.
PLANNED Animal Treatment Elements: Screen → Treatment (300 mg/kg Drug A) → Treatment (500 mg/kg Drug B) → Recovery
ACTUAL Animal Treatment Elements: Screen → Treatment (300 mg/kg Drug A) → Treatment (500 mg/kg Drug B) SKIPPED → Recovery
se.xpt
Row | STUDYID | DOMAIN | USUBJID | SESEQ | ETCD | ELEMENT | SESTDTC | SEENDTC |
1 | CDF2 | SE | CDF2-001 | 1 | PRETEST | Screen | 2008-01-08 | 2008-01-14T07:00 |
2 | CDF2 | SE | CDF2-001 | 2 | TREATA | Vehicle Control | 2008-01-14T07:00 | 2008-01-27T09:00 |
3 | CDF2 | SE | CDF2-001 | 3 | RECOVERY | Rest | 2008-01-27T09:00 | 2008-02-02T07:00 |
4 | CDF2 | SE | CDF2-010 | 1 | PRETEST | Screen | 2008-01-08 | 2008-01-14T07:00 |
5 | CDF2 | SE | CDF2-010 | 2 | TREATB | 100 mg/kg Drug A | 2008-01-14T07:00 | 2008-01-22T09:30 |
6 | CDF2 | SE | CDF2-010 | 3 | TREATC | 100 mg/kg Drug B | 2008-01-22T09:30 | 2008-01-28T09:30 |
7 | CDF2 | SE | CDF2-010 | 4 | RECOVERY | Rest | 2008-01-28T09:30 | 2008-02-02T07:00 |
8 | CDF2 | SE | CDF2-020 | 1 | PRETEST | Screen | 2008-01-08 | 2008-01-13T07:00 |
9 | CDF2 | SE | CDF2-020 | 2 | TREATD | 300 mg/kg Drug A | 2008-01-13T07:00 | 2008-01-21T10:30 |
10 | CDF2 | SE | CDF2-020 | 3 | RECOVERY | Rest | 2008-01-21T10:30 | 2008-02-02T07:00 |
Domain Models Based on the General Observation Classes
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
DOMAIN | Domain Abbreviation | Char | EX | Identifier | Two-character abbreviation for the domain. | Req |
USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Either USUBJID or POOLID must be populated. | Exp | |
POOLID | Pool Identifier | Char | Identifier | Identifier used for pooling subjects to assign a single finding to multiple subjects. If POOLID is entered, POOLDEF records must exist for each subject and the USUBJID must be null. Either USUBJID or POOLID must be populated. | Perm | |
FOCID | Focus of Study- Specific Interest | Char | Identifier | Identification of a focus of study-specific interest on or within a subject or specimen as defined in the protocol for which a measurement, test, or examination was performed, such as a drug application site, e.g., "Injection site 1," "Biopsy site 1," "Treated site 1." the value in this variable should have inherent semantic value. | Perm | |
EXSEQ | Sequence Number | Num | Identifier | The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record. | Req | |
EXTRT | Name of Actual Treatment | Char | Topic | Name of the treatment, as defined by the protocol. | Req | |
EXDOSE | Dose per Administration | Num | Record Qualifier | Amount of treatment administered. | Exp | |
EXDOSTXT | Dose Description | Char | Record Qualifier | If the amount of treatment administered cannot be represented as a number and populated in EXDOSE, this field is used to describe the amount of treatment administered. Example: 200-400. | Perm | |
EXDOSU | Dose Units | Char | Variable Qualifier | Units for EXDOSE or EXDOSTXT. Examples: ng, mg, or mg/kg. | Exp | |
EXDOSFRM | Dose Form | Char | Variable Qualifier | Dose form for treatment (form administered). Examples: TABLET, LOTION. | Exp | |
EXDOSFRQ | Dosing Frequency Per Interval | Char | Variable Qualifier | Usually expressed as the number of repeated administrations of EXDOSE within a specific time period. Examples: QD (once daily), BID (2x daily). | Req | |
EXROUTE | Route of Administration | Char | Variable Qualifier | Route of administration for EXTRT. Examples: ORAL GAVAGE, DERMAL, INTRAVENOUS. | Req | |
EXLOT | Lot Number | Char | Record Qualifier | Lot Number(s) or Batch Number(s) of the EXTRT test article. If mixed lots of the test article are administered during the same constant dosing interval, this should be represented as "Lot A;Lot B." Mixed lots are produced by the mixing of Lots a and B of the test article into one solution, | Exp |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
suspension, or dietary food concentration. If no test article was administered, EXLOT should be null. | ||||||
EXLOC | Location of Dose Administration | Char | Record Qualifier | Specifies anatomical location (site) of administration. Example: LEFT HINDLIMB for a topical application or an injection site number. Each administration will require its own record. | Perm | |
EXMETHOD | Method of Administration | Char | Record Qualifier | Method of the dose administration. Example: INFUSION. | Perm | |
EXTRTV | Treatment Vehicle | Char | Record Qualifier | Describes vehicle used for treatment. Example: SALINE. | Exp | |
EXVAMT | Amount Administered | Num | Record Qualifier | The amount (volume or weight) of the treatment compound plus vehicle administered in a single dose. This is not to be confused with EXDOSE. EXDOSE refers to the amount of test material administered to the subject. | Perm | |
EXVAMTU | Amount Administered Units | Char | Variable Qualifier | Units for EXVAMT (per dose administration). | Perm | |
EXADJ | Reason for Dose Adjustment | Char | Record Qualifier | Describes reason or explanation of why a dose is adjusted – used only when an adjustment is represented in EX. May be used for variations from protocol-specified doses or changes from expected doses (e.g., when dose is adjusted due to toxicity). | Perm | |
EXSTDTC | Start Date/Time of Treatment | Char | ISO 8601 | Timing | Date/Time when administration of the treatment indicated by EXTRT and EXDOSE began, in ISO 8601 format. | Exp |
EXENDTC | End Date/Time of Treatment | Char | ISO 8601 | Timing | Date/Time when administration of the treatment indicated by EXTRT and EXDOSE ended, in ISO 8601 format. | Perm |
EXSTDY | Study Day of Start of Treatment | Num | Timing | Study day when administration of the treatment began, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | |
EXENDY | Study Day of End of Treatment | Num | Timing | Study day when administration of the treatment ended, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | |
EXDUR | Duration of Treatment | Char | ISO 8601 | Timing | Duration and unit of time for a continuous treatment. This may be used to denote the length of an infusion (e.g., PT10M to indicate 10 minutes). | Perm |
EXTPT | Planned Time Point Name | Char | Timing | Text description of time when a dose should be given. Note: This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See EXTPTNUM and EXTPTREF. | Perm | |
EXTPTNUM | Planned Time Point Number | Num | Timing | Numerical version of EXTPT to aid in sorting. | Perm | |
EXELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 | Timing | Planned elapsed time (in ISO 8601 format) relative to the planned fixed reference (EXTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: "- PT15M" to represent the period of 15 minutes prior to the reference point indicated by EXTPTREF, or "PT8H" to represent the period of 8 hours after the reference point indicated by EXTPTREF. | Perm |
EXTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by EXELTM, if used for EXTPTNUM, and EXTPT. It is recommended that EXTPTREF be as descriptive as possible so the reference time point can be inferred without looking at other variables. Examples: Previous dose, previous feed. | Perm |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
EXRFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 | Timing | Date/Time of the reference time point, EXTPTREF. | Perm |
Assumptions for Exposure (EX) Domain Model
Definition:
The Exposure (EX) domain model records the details of a subject's administered dose of protocol-specified study treatment. "Study treatment" may be any intervention that is prospectively defined as a test material within a study, and is typically, but not always, administered to the subject. Examples include but are not limited to placebo, active comparators, and investigational products. Only protocol-specified treatments should be included in this domain.
This domain should contain 1 record per constant dosing interval per subject per administration site (as identified in FOCID). A constant dosing interval is sponsor-defined and represents a specific period of time during which a subject was treated with a specific lot at a constant dose level. For example, for a study with once-a-week administration of a standard dose for 6 weeks, the administered dose may be represented with a single record per subject, spanning the entire treatment phase. Alternatively, a separate entry can be made for each treatment administration and for any deviations in treatment that occur. For this example, there could be up to 6 records (one for each weekly administration).
Either USUBJID or POOLID must be populated.
Treatment description:
EXTRT captures the name of the administered treatment. Because EXTRT is the topic variable, it is required and must have a value. EXTRT should include only the treatment name and should not include dosage, formulation, or other qualifying information. For example, "ASPIRIN 100 mg TABLET" is not a valid value for EXTRT. This example should be expressed as EXTRT= "ASPIRIN," EXDOSE= "100," EXDOSU= "mg," and EXDOSFRM= "TABLET".
A single control for multiple compounds should contain values separated with a pipe/vertical bar (|).
If a subject is treated sequentially with different lots, then a new record must be created for each lot number given.
EXDOSE: The sponsor's data definition file should indicate whether the values in EXDOSE represent intended or actual dose levels.
Timing variables: The timing of dosing of study treatment is captured by the start/end date and start/end time of each constant-dosing interval. The sponsor defines the dosing interval.
Other additional qualifiers from the SDTM Interventions class may be added to this domain.
Examples for Exposure (EX) Domain Model
Example 1: Intravenous Dosing
This is an example of an EX dataset for selected animals from a typical nonclinical study. Subjects were randomized to 1 of 4 treatment groups with 1 test article at 3 different treatment levels (20 mg/kg, 40 mg/kg, 120 mg/kg) with once-daily administration and 1 control. The test article was infused intravenously for a duration of 10 minutes.
ex.xpt
Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXDOSFRQ | EXROUTE | EXLOT | EXLOC | EXMETHOD | EXTRTV | EXVAMT | EXVAMTU | EXSTDTC | EXENDTC | EXSTDY | EXENDY | EXDUR |
1 | 12345 | EX | 12345001 | 1 | CX2345 | 0 | mg/kg | SOLUTION | QD | INTRAVENOUS | Left forelimb | INFUSION | Saline | 5 | mL | 2008-04-08T09:00 | 2008-04-08T09:10 | 1 | 1 | PT10M | |
2 | 12345 | EX | 12345002 | 2 | CX2345 | 20 | mg/kg | SOLUTION | QD | INTRAVENOUS | AB789.1 | Left forelimb | INFUSION | Saline | 5 | mL | 2008-04-09T09:00 | 2008-04-09T09:10 | 2 | 2 | PT10M |
3 | 12345 | EX | 12345003 | 3 | CX2345 | 40 | mg/kg | SOLUTION | QD | INTRAVENOUS | AB789.1 | Left forelimb | INFUSION | Saline | 5 | mL | 2008-04-10T09:00 | 2008-04-10T09:10 | 3 | 3 | PT10M |
4 | 12345 | EX | 12345004 | 4 | CX2345 | 120 | mg/kg | SOLUTION | QD | INTRAVENOUS | AB789.1 | Left forelimb | INFUSION | Saline | 5 | mL | 2008-04-11T09:00 | 2008-04-11T09:10 | 4 | 4 | PT10M |
Example 2: Capsule Dosing Represented as 1 Record per Dose
This is an example of an EX dataset for a dose-ranging study where a pair of animals (non-rodent) is administered the test article at ascending doses until the maximum-tolerated dose is reached. There was a minimum 2-day washout period between doses. Before each dose administration, the animals were food deprived for 12 hours and were fed for 1 hour after dose administration on the days of treatment.
ex.xpt
Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXDOSFRQ | EXROUTE | EXLOT | EXTRTV | EXSTDTC | EXENDTC | EXSTDY | EXENDY | EXTPT | EXTPTREF |
1 | 12345 | EX | 12345001 | 1 | FDA23456 | 20 | mg/kg | CAPSULE | QD | ORAL | FDA.099 | 2002-10-01 | 2002-10-01 | 1 | 1 | 12 hours | PREVIOUS FEED | |
2 | 12345 | EX | 12345001 | 2 | FDA23456 | 60 | mg/kg | CAPSULE | QD | ORAL | FDA.099 | 2002-10-04 | 2002-10-04 | 4 | 4 | 12 hours | PREVIOUS FEED | |
3 | 12345 | EX | 12345001 | 3 | FDA23456 | 100 | mg/kg | CAPSULE | QD | ORAL | FDA.099 | 2002-10-08 | 2002-10-08 | 8 | 8 | 12 hours | PREVIOUS FEED | |
4 | 12345 | EX | 12345001 | 4 | FDA23456 | 75 | mg/kg | CAPSULE | QD | ORAL | FDA.099 | 2002-10-11 | 2002-10-11 | 11 | 11 | 12 hours | PREVIOUS FEED | |
5 | 12345 | EX | 12345002 | 5 | FDA23456 | 20 | mg/kg | CAPSULE | QD | ORAL | FDA.099 | 2002-10-01 | 2002-10-01 | 1 | 1 | 12 hours | PREVIOUS FEED | |
6 | 12345 | EX | 12345002 | 6 | FDA23456 | 60 | mg/kg | CAPSULE | QD | ORAL | FDA.099 | 2002-10-04 | 2002-10-04 | 4 | 4 | 12 hours | PREVIOUS FEED | |
7 | 12345 | EX | 12345002 | 7 | FDA23456 | 100 | mg/kg | CAPSULE | QD | ORAL | FDA.099 | 2002-10-08 | 2002-10-08 | 8 | 8 | 12 hours | PREVIOUS FEED | |
8 | 12345 | EX | 12345002 | 8 | FDA23456 | 75 | mg/Kg | CAPSULE | QD | ORAL | FDA.099 | 2002-10-11 | 2002-10-11 | 11 | 11 | 12 hours | PREVIOUS FEED |
Example 3: Oral Dosing Reported with 1 Record for Multiple Days of Dosing
This is an example of an EX dataset for selected animals from a typical nonclinical study. In this example, subjects were randomized to 1 of 4 treatment groups: the test article at dose levels of 20, 40, and 100 mg/kg/day (single daily administration), and 1 control. The study included 13 weeks of treatment. However, due to severe clinical signs, the dose level for subject 12345004 was reduced from 100 to 75 during week
6. The other subjects remained on the same treatment throughout the study. With respect to timing of doses, the sponsor only collected the start and stop dates of uninterrupted periods of treatment.
ex.xpt
Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXDOSFRQ | EXROUTE | EXLOT | EXTRTV | EXADJ | EXSTDTC | EXENDTC | EXSTDY | EXENDY |
1 | 12345 | EX | 12345001 | 1 | CX2345 | 0 | mg/kg | SUSPENSION | QD | ORAL GAVAGE | CMC | 2007-01-08 | 2007-04-08 | 1 | 91 | ||
2 | 12345 | EX | 12345002 | 2 | CX2345 | 20 | mg/kg | SUSPENSION | QD | ORAL GAVAGE | AB789.1 | CMC | 2007-01-08 | 2007-04-08 | 1 | 91 | |
3 | 12345 | EX | 12345003 | 3 | CX2345 | 40 | mg/kg | SUSPENSION | QD | ORAL GAVAGE | AB789.1 | CMC | 2007-01-08 | 2007-04-08 | 1 | 91 | |
4 | 12345 | EX | 12345004 | 4 | CX2345 | 100 | mg/kg | SUSPENSION | QD | ORAL GAVAGE | AB789.1 | CMC | 2007-01-08 | 2007-02-16 | 1 | 40 |
Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXDOSFRQ | EXROUTE | EXLOT | EXTRTV | EXADJ | EXSTDTC | EXENDTC | EXSTDY | EXENDY |
5 | 12345 | EX | 12345004 | 5 | CX2345 | 75 | mg/kg | SUSPENSION | QD | ORAL GAVAGE | AB789.1 | CMC | Reduced due to toxicity | 2007-02-17 | 2007-04-09 | 41 | 91 |
Example 4: Dermal Dosing with 1 Record for Multiple Days of Dosing
This is an example of an EX dataset for selected animals from a typical nonclinical study. The test article was administered twice a day by dermal application for 91 days, after which the animals were euthanized. The test article was applied to 10% of the body surface. The formulation was administered as supplied at 0.01%. The exposure was calculated using the weekly body weights. In the example below, results are shown for 1 subject during the first five weeks of the study.
ex.xpt
Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXDOSFRQ | EXROUTE | EXLOT | EXLOC | EXTRTV | EXVAMT | EXVAMTU | EXSTDTC | EXENDTC | EXSTDY | EXENDY |
1 | 12345 | EX | 12345001 | 1 | E453 | 0.28 | mg/kg | LOTION | BID | TOPICAL | RTE567 | DORSAL | Diethyl Sebacate, JPE (5.0%), Benzyl Alcohol, NF (1.0%), White Petrolatum, USP (10.0%) | 0.05 | mL | 2007-01- 07 | 2007-01- 13 | 1 | 7 |
2 | 12345 | EX | 12345001 | 2 | E453 | 0.29 | mg/kg | LOTION | BID | TOPICAL | RTE567 | DORSAL | Diethyl Sebacate, JPE (5.0%), Benzyl Alcohol, NF (1.0%), White Petrolatum, USP (10.0%) | 0.06 | mL | 2007-01- 14 | 2007-01- 20 | 8 | 14 |
3 | 12345 | EX | 12345001 | 3 | E453 | 0.28 | mg/kg | LOTION | BID | TOPICAL | RTE567 | DORSAL | Diethyl Sebacate, JPE (5.0%), Benzyl Alcohol, NF (1.0%), White Petrolatum, USP (10.0%) | 0.06 | mL | 2007-01- 21 | 2007-01- 27 | 15 | 21 |
4 | 12345 | EX | 12345001 | 4 | E453 | 0.26 | mg/kg | LOTION | BID | TOPICAL | RTE567 | DORSAL | Diethyl Sebacate, JPE (5.0%), Benzyl Alcohol, NF (1.0%), White Petrolatum, USP (10.0%) | 0.05 | mL | 2007-01- 28 | 2007-02- 05 | 22 | 30 |
5 | 12345 | EX | 12345001 | 5 | E453 | 0.27 | mg/kg | LOTION | BID | TOPICAL | RTE567 | DORSAL | Diethyl Sebacate, JPE (5.0%), Benzyl Alcohol, NF (1.0%), White Petrolatum, USP (10.0%) | 0.05 | mL | 2007-02- 06 | 2007-02- 12 | 31 | 37 |
Example 5: Diet Dosing
This is an example of an EX dataset for selected animals; subjects were randomized to 1 of 4 treatment groups. The animals were group housed, so exposure has been derived for each animal. The test article was administered in the diet for 13 weeks at concentrations of 0 ppm, 300 ppm, 750 ppm, and 1500 ppm. The administered dose was calculated based on food consumption and body weight, using the following formula:
Exposure = [ Dietary concentration (mg/kg) × Food consumption (g/rat/day) ] / Body weight (g)
ex.xpt
Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXDOSFRQ | EXROUTE | EXLOT | EXTRTV | EXSTDTC | EXENDTC | EXSTDY | EXENDY |
1 | 12345 | EX | 12345001 | 1 | PHJU | 26.91 | mg/kg/day | POWDER | AD LIBITUM | DIETARY | ABC1 | FEED | 2007-06-07T07:30 | 2007-06-13T07:30 | 1 | 7 |
2 | 12345 | EX | 12345001 | 2 | PHJU | 23.43 | mg/kg/day | POWDER | AD LIBITUM | DIETARY | ABC1;ABC2 | FEED | 2007-06-13T7:30 | 2007-06-20 T7:30 | 7 | 14 |
3 | 12345 | EX | 12345001 | 3 | PHJU | 20.63 | mg/kg/day | POWDER | AD LIBITUM | DIETARY | ABC2 | FEED | 2007-06-20T7:30 | 2007-06-27T7:30 | 14 | 21 |
Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXDOSFRQ | EXROUTE | EXLOT | EXTRTV | EXSTDTC | EXENDTC | EXSTDY | EXENDY |
4 | 12345 | EX | 12345025 | 4 | PHJU | 53.52 | mg/kg/day | POWDER | AD LIBITUM | DIETARY | DEF1 | FEED | 2007-06-07T7:30 | 2007-06-13T7:30 | 1 | 7 |
5 | 12345 | EX | 12345025 | 5 | PHJU | 46.87 | mg/kg/day | POWDER | AD LIBITUM | DIETARY | DEF1 | FEED | 2007-06-13T7:30 | 2007-06-20T7:30 | 7 | 14 |
6 | 12345 | EX | 12345025 | 6 | PHJU | 43.53 | mg/kg/day | POWDER | AD LIBITUM | DIETARY | DEF1 | FEED | 2007-06-20T7:30 | 2007-06-27T7:30 | 17 | 21 |
Example 6: Continuous Intravenous Dosing with Periods of Test Article and Periods of Saline
This is an example of an EX dataset for 1 animal from a continuous infusion study. The infusion pump was set in a 24-hour cycle to deliver the test article over a duration of 6 hours and saline for 18 hours. In the 6- hour dosing period, the animals received 10 ug/kg/hour; in the remaining period they received only saline in a constant infusion rate of 1 mL/kg/hour. In this example, results are shown for subject 12345 during the first 3 24-hour cycles. The animal did not receive the whole dose on day 3 due to a pump failure.
ex.xpt
Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXDOSFRQ | EXROUTE | EXLOT | EXMETHOD | EXTRTV | EXVAMT | EXVAMTU | EXADJ | EXSTDTC | EXENDTC | EXSTDY | EXENDY |
1 | 12345 | EX | 12345001 | 1 | GF2145 | 10 | ug/kg/hour | SOLUTION | CONTINUOUS | INTRAVENOUS | 2013.34 | CONTINUOUS INFUSION | Saline | 1 | mL/kg/hour | 2013-01-08T08:00 | 2013-01-08T14:00 | 1 | 1 | |
2 | 12345 | EX | 12345001 | 2 | GF2145 | 0 | ug/kg/hour | SOLUTION | CONTINUOUS | INTRAVENOUS | CONTINUOUS INFUSION | Saline | 1 | mL/kg/hour | 2013-01-08T14:00 | 2013-01-09T08:00 | 1 | 2 | ||
3 | 12345 | EX | 12345001 | 3 | GF2145 | 10 | ug/kg/hour | SOLUTION | CONTINUOUS | INTRAVENOUS | 2013.34 | CONTINUOUS INFUSION | Saline | 1 | mL/kg/hour | 2013-01-09T08:00:00 | 2013-01-09T14:00 | 2 | 2 | |
4 | 12345 | EX | 12345001 | 4 | GF2145 | 0 | ug/kg/hour | SOLUTION | CONTINUOUS | INTRAVENOUS | CONTINUOUS INFUSION | Saline | 1 | mL/kg/hour | 2013-01-09T14:00 | 2013-01-10T08:00 | 2 | 3 | ||
5 | 12345 | EX | 12345001 | 5 | GF2145 | 8 | ug/kg/hour | SOLUTION | CONTINUOUS | INTRAVENOUS | 2013.34 | CONTINUOUS INFUSION | Saline | 1 | mL/kg/hour | Pump failure | 2013-01-10T08:00:00 | 2013-01-10T14:00 | 3 | 3 |
6 | 12345 | EX | 12345001 | 6 | GF2145 | 0 | ug/kg/hour | SOLUTION | CONTINUOUS | INTRAVENOUS | CONTINUOUS INFUSION | Saline | 1 | mL/kg/hour | 2013-01-10T14:00 | 2013-01-11T08:00 | 3 | 4 |
Example 7: Intraperitoneal Exposure with 1 Record for Multiple Dosing Days
This is an example of an EX dataset for selected animals from a toxicology study using a vehicle and positive control groups with once-daily intraperitoneal administration for 5 days. Subjects were randomized to 1 of 5 groups with 1 test article at 3 different treatment levels (10 mg/kg, 25 mg/kg, and 100 mg/kg), 1 vehicle control and a positive control group receiving 40 mg/kg cyclophosphamide. In this example, results are shown for five subjects, 1 in each group with 1 record per constant dosing interval of five days.
ex.xpt
Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXDOSFRQ | EXROUTE | EXLOT | EXTRTV | EXVAMT | EXVAMTU | EXSTDTC | EXENDTC | EXSTDY | EXENDY | EXDUR | |
1 | 12345 | EX | 12345001 | 1 | RP187 | Cyclophosphamide | 0 | mg/kg | SOLUTION | QD | INTRAPERITONEAL | Saline | 5 | mL | 2013-08-20 | 2013-08-24 | 1 | 5 | PT5D | |
2 | 12345 | EX | 12345002 | 2 | RP187 | 10 | mg/kg | SOLUTION | QD | INTRAPERITONEAL | Ta.1308 | Saline | 5 | mL | 2013-08-20 | 2013-08-24 | 1 | 5 | PT5D | |
3 | 12345 | EX | 12345003 | 3 | RP187 | 25 | mg/kg | SOLUTION | QD | INTRAPERITONEAL | Ta.1308 | Saline | 5 | mL | 2013-08-20 | 2013-08-24 | 1 | 5 | PT5D | |
4 | 12345 | EX | 12345004 | 4 | RP187 | 100 | mg/kg | SOLUTION | QD | INTRAPERITONEAL | Ta.1308 | Saline | 5 | mL | 2013-08-20 | 2013-08-24 | 1 | 5 | PT5D | |
5 | 12345 | EX | 12345005 | 5 | Cyclophosphamide | 40 | mg/kg | SOLUTION | QD | INTRAPERITONEAL | Pc.1308 | Saline | 5 | mL | 2013-08-20 | 2013-08-24 | 1 | 5 | PT5D |
Example 8: Oral Gavage - 1 Record per Dosing with Multiple Treatments
This is an example of an EX dataset for selected animals from a toxicology study using 2 treatments and a vehicle control with once-weekly oral administration. Subjects were randomized to 1 of 5 groups. In this example, results are shown for 5 animals, 1 in each group, with 1 record each for the first 2 weeks. For the control group, the treatment is listed as the 2 treatment substances, concatenated with a pipe and zero dose.
ex.xpt
Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXDOSFRQ | EXROUTE | EXLOT | EXTRTV | EXVAMT | EXVAMTU | EXSTDTC | EXSTDY |
1 | 12345 | EX | 12345001 | 1 | RP187|RP188 | 0 | mg/kg | SOLUTION | 1 TIME PER WEEK | ORAL GAVAGE | Saline | 5 | mL | 2013-08-20 | 1 | |
2 | 12345 | EX | 12345002 | 2 | RP187 | 10 | mg/kg | SOLUTION | 1 TIME PER WEEK | ORAL GAVAGE | Ta.1308 | Saline | 5 | mL | 2013-08-20 | 1 |
Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXDOSFRQ | EXROUTE | EXLOT | EXTRTV | EXVAMT | EXVAMTU | EXSTDTC | EXSTDY |
3 | 12345 | EX | 12345003 | 3 | RP187 | 100 | mg/kg | SOLUTION | 1 TIME PER WEEK | ORAL GAVAGE | Ta.1308 | Saline | 5 | mL | 2013-08-20 | 1 |
4 | 12345 | EX | 12345004 | 4 | RP188 | 10 | mg/kg | SOLUTION | 1 TIME PER WEEK | ORAL GAVAGE | Ta.2212 | Saline | 5 | mL | 2013-08-20 | 1 |
5 | 12345 | EX | 12345005 | 5 | RP188 | 100 | mg/kg | SOLUTION | 1 TIME PER WEEK | ORAL GAVAGE | Ta.2212 | Saline | 5 | mL | 2013-08-20 | 1 |
6 | 12345 | EX | 12345001 | 6 | RP187|RP188 | 0 | mg/kg | SOLUTION | 1 TIME PER WEEK | ORAL GAVAGE | Saline | 5 | mL | 2013-08-27 | 8 | |
7 | 12345 | EX | 12345002 | 7 | RP187 | 10 | mg/kg | SOLUTION | 1 TIME PER WEEK | ORAL GAVAGE | Ta.1308 | Saline | 5 | mL | 2013-08-27 | 8 |
8 | 12345 | EX | 12345003 | 8 | RP187 | 100 | mg/kg | SOLUTION | 1 TIME PER WEEK | ORAL GAVAGE | Ta.1308 | Saline | 5 | mL | 2013-08-27 | 8 |
9 | 12345 | EX | 12345004 | 9 | RP188 | 10 | mg/kg | SOLUTION | 1 TIME PER WEEK | ORAL GAVAGE | Ta.2212 | Saline | 5 | mL | 2013-08-27 | 8 |
10 | 12345 | EX | 12345005 | 10 | RP188 | 100 | mg/kg | SOLUTION | 1 TIME PER WEEK | ORAL GAVAGE | Ta.2212 | Saline | 5 | mL | 2013-08-27 | 8 |
Example 9: Subcutaneous Dosing with Multiple Sites
This is an example of an EX dataset for selected animals from a local toxicity study including where local tolerance assessment is the most important endpoint. The identification of injection sites is carried throughout the study for all measurements performed across domains.
The 4 injection sites per subject received a different treatment each. Injection site 1 serves as control, receiving only saline. Note that the FOCID variable completes the natural key, providing a level of granularity that would otherwise be missing with existing variables.
ex.xpt
Row | STUDYID | DOMAIN | USUBJID | FOCID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXDOSFRQ | EXROUTE | EXLOT | EXTRTV | EXVAMT | EXVAMTU | EXSTDTC | EXSTDY |
1 | 12345 | EX | 12345001 | Injection site 1 | 1 | RP187 | 0 | mg/kg | SOLUTION | QD | SUBCUTANEOUS | Saline | 0.2 | mL | 2013-08-20 | 1 | |
2 | 12345 | EX | 12345001 | Injection site 2 | 2 | RP187 | 10 | mg/kg | SOLUTION | QD | SUBCUTANEOUS | Ta.1308 | Saline | 0.2 | mL | 2013-08-20 | 1 |
3 | 12345 | EX | 12345001 | Injection site 3 | 3 | RP187 | 25 | mg/kg | SOLUTION | QD | SUBCUTANEOUS | Ta.1308 | Saline | 0.2 | mL | 2013-08-20 | 1 |
4 | 12345 | EX | 12345001 | Injection site 4 | 4 | RP187 | 100 | mg/kg | SOLUTION | QD | SUBCUTANEOUS | Ta.1308 | Saline | 0.2 | mL | 2013-08-20 | 1 |
5 | 12345 | EX | 12345002 | Injection site 1 | 1 | RP187 | 0 | mg/kg | SOLUTION | QD | SUBCUTANEOUS | Saline | 0.2 | mL | 2013-08-20 | 1 | |
6 | 12345 | EX | 12345002 | Injection site 2 | 2 | RP187 | 10 | mg/kg | SOLUTION | QD | SUBCUTANEOUS | Ta.1308 | Saline | 0.2 | mL | 2013-08-20 | 1 |
7 | 12345 | EX | 12345002 | Injection site 3 | 3 | RP187 | 25 | mg/kg | SOLUTION | QD | SUBCUTANEOUS | Ta.1308 | Saline | 0.2 | mL | 2013-08-20 | 1 |
8 | 12345 | EX | 12345002 | Injection site 4 | 4 | RP187 | 100 | mg/kg | SOLUTION | QD | SUBCUTANEOUS | Ta.1308 | Saline | 0.2 | mL | 2013-08-20 | 1 |
Example 10: Oral Dosing Reported with 2 Records for Each Day of Dosing; 2 Test Articles Administered per Treatment Group; Treatments Administered Consecutively
In this example, each treatment group received daily administration of 2 test articles in separate doses, one after the other. Each test article utilized a different vehicle, and a control group received both vehicles.
ex.xpt
Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXDOSFRQ | EXROUTE | EXLOT | EXTRTV | EXSTDTC | EXSTDY |
1 | 12345 | EX | 12345001 | 1 | TA1 | 0 | mg/kg | SUSPENSION | QD | ORAL | Vehicle 1 | 2007-01-01T08:52 | 1 | |
2 | 12345 | EX | 12345001 | 2 | TA2 | 0 | mg/kg | SUSPENSION | QD | ORAL | Vehicle 2 | 2007-01-01T08:53 | 1 | |
3 | 12345 | EX | 12345001 | 3 | TA1 | 0 | mg/kg | SUSPENSION | QD | ORAL | Vehicle 1 | 2007-01-02 T08:54 | 2 | |
4 | 12345 | EX | 12345001 | 4 | TA2 | 0 | mg/kg | SUSPENSION | QD | ORAL | Vehicle 2 | 2007-01-02 T08:55 | 2 | |
5 | 12345 | EX | 12345001 | 5 | TA1 | 0 | mg/kg | SUSPENSION | QD | ORAL | Vehicle 1 | 2007-01-03 T08:56 | 3 | |
6 | 12345 | EX | 12345001 | 6 | TA2 | 0 | mg/kg | SUSPENSION | QD | ORAL | Vehicle 2 | 2007-01-03 T08:57 | 3 | |
7 | 12345 | EX | 12345002 | 7 | TA1 | 20 | mg/kg | SUSPENSION | QD | ORAL | ABC123 | Vehicle 1 | 2007-01-01 T08:58 | 1 |
8 | 12345 | EX | 12345002 | 8 | TA2 | 40 | mg/kg | SUSPENSION | QD | ORAL | CDE456 | Vehicle 2 | 2007-01-01 T08:59 | 1 |
9 | 12345 | EX | 12345002 | 9 | TA1 | 20 | mg/kg | SUSPENSION | QD | ORAL | ABC123 | Vehicle 1 | 2007-01-02 T08:40 | 2 |
10 | 12345 | EX | 12345002 | 10 | TA2 | 40 | mg/kg | SUSPENSION | QD | ORAL | CDE456 | Vehicle 2 | 2007-01-02 T08:41 | 2 |
11 | 12345 | EX | 12345002 | 11 | TA1 | 20 | mg/kg | SUSPENSION | QD | ORAL | ABC123 | Vehicle 1 | 2007-01-03 T08:42 | 3 |
12 | 12345 | EX | 12345002 | 12 | TA2 | 40 | mg/kg | SUSPENSION | QD | ORAL | CDE456 | Vehicle 2 | 2007-01-03 T08:43 | 3 |
13 | 12345 | EX | 12345003 | 13 | TA1 | 40 | mg/kg | SUSPENSION | QD | ORAL | ABC123 | Vehicle 1 | 2007-01-01 T08:44 | 1 |
14 | 12345 | EX | 12345003 | 14 | TA2 | 60 | mg/kg | SUSPENSION | QD | ORAL | CDE456 | Vehicle 2 | 2007-01-01 T08:45 | 1 |
15 | 12345 | EX | 12345003 | 15 | TA1 | 40 | mg/kg | SUSPENSION | QD | ORAL | ABC123 | Vehicle 1 | 2007-01-02 T08:46 | 2 |
16 | 12345 | EX | 12345003 | 16 | TA2 | 60 | mg/kg | SUSPENSION | QD | ORAL | CDE456 | Vehicle 2 | 2007-01-02 T08:47 | 2 |
17 | 12345 | EX | 12345003 | 17 | TA1 | 40 | mg/kg | SUSPENSION | QD | ORAL | ABC123 | Vehicle 1 | 2007-01-03 T08:48 | 3 |
18 | 12345 | EX | 12345003 | 18 | TA2 | 60 | mg/kg | SUSPENSION | QD | ORAL | CDE456 | Vehicle 2 | 2007-01-03 T08:49 | 3 |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
DOMAIN | Domain Abbreviation | Char | DS | Identifier | Two-character abbreviation for the domain. | Req |
USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
DSSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | |
DSTERM | Reported Term for the Disposition Event | Char | Topic | DSTERM is the original term recorded for subject disposition. DSTERM is not under controlled terminology, but should be mapped to DSDECOD. | Req | |
DSDECOD | Standardized Disposition Term | Char | Synonym Qualifier | Contains the result in a standard format. | Req | |
DSUSCHFL | Unscheduled Flag | Char | Record Qualifier | Indicates whether the subject's disposition was unscheduled. If the subject's disposition was based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null. | Exp | |
VISITDY | Planned Study Day of Disposition | Num | Timing | Planned study day of collection. Should be an integer. VISITDY should be populated only when DSTERM represents a scheduled activity. | Perm | |
DSSTDTC | Date/Time of Disposition | Char | ISO 8601 | Timing | Date/Time of the disposition event, in ISO 8601 format. | Req |
DSSTDY | Study Day of Disposition | Num | Timing | Study day of the disposition event, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | |
DSNOMDY | Nominal Study Day for Tabulations | Num | Timing | Nominal study day used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer. | Exp | |
DSNOMLBL | Label for Nominal Study Day | Char | Timing | A label for a given value of DSNOMDY as presented in the study report. Examples: Week 4, Day 28, Terminal Sac. | Perm |
Assumptions for Disposition (DS) Domain Model
Definition:
The Disposition (DS) dataset provides a record of the final disposition of subjects, which can be recorded at any stage throughout a study. At study completion, a record must exist for each subject in the study.
Disposition records are required for carcinogenicity studies to support the creation of the tumor.xpt file.
The DSDECOD values of MISSING, REMOVED FROM STUDY ALIVE, RECOVERY SACRIFICE, and NON-MORIBUND SACRIFICE do
not map to the DTHSACST variable of the tumor.xpt (see Appendix C2, Mapping DSDECOD to DTHSACST).
DS Description and coding: DSTERM is not under controlled terminology, but should be mapped to controlled terminology for DSDECOD.
Timing variables:
DSSTDTC is used for the date/time of the disposition event. Disposition events do not have end dates, because these events do not span an interval but occur at a single date/time (e.g., date of terminal sacrifice). The use of an interval of uncertainty, as described in Section 4.4.2, Date/Time Precision, cannot be used for DSSTDTC.
Examples for Disposition (DS) Domain Model
Example 1
This example shows a typical DS dataset; subjects were sacrificed by exsanguination. The date values are entered in ISO 8601 format and include the time of sacrifice.ds.
ds.xpt
Row | STUDYID | DOMAIN | USUBJID | DSSEQ | DSTERM | DSDECOD | DSSTDTC | DSSTDY | DSNOMDY |
1 | 840515 | DS | xx-xx75 | 1 | Exsanguinated | TERMINAL SACRIFICE | 1996-07-30T08:13:00 | 29 | 28 |
2 | 840515 | DS | xx-xx76 | 1 | Exsanguinated | TERMINAL SACRIFICE | 1996-07-30T08:40:00 | 29 | 28 |
3 | 840515 | DS | xx-xx77 | 1 | Exsanguinated | TERMINAL SACRIFICE | 1996-07-29T08:13:00 | 28 | 28 |
Example 2
This example shows a more complex DS dataset, and illustrates how to handle different days that subjects were disposed. The sponsor has included the label under which the deaths were grouped in the study report.
ds.xpt
Row | STUDYID | DOMAIN | USUBJID | DSSEQ | DSTERM | DSDECOD | DSUSCHFL | DSSTDTC | DSSTDY | DSNOMDY | DSNOMLBL |
1 | 840516 | DS | xx-xx82 | 1 | Animal escaped/Found dead | ACCIDENTAL DEATH | Y | 1996-03-01T08:10 | 28 | 28 | Unscheduled Death |
2 | 840516 | DS | xx-xx83 | 1 | Final Phase sacrifice | TERMINAL SACRIFICE | 1996-03-02T17:40 | 29 | 28 | Terminal Sacrifice | |
3 | 840516 | DS | xx-xx84 | 1 | Final Phase sacrifice | TERMINAL SACRIFICE | 1996-03-01T08:13 | 28 | 28 | Terminal Sacrifice |
Example 3
This is another example of a complex DS dataset. It shows 2 different types of disposition events for subjects in this study: 1 for subjects that were sacrificed and another for a subject that was removed from the study alive.
ds.xpt
Row | STUDYID | DOMAIN | USUBJID | DSSEQ | DSTERM | DSDECOD | DSSTDTC | DSSTDY | DSNOMDY |
1 | 840522 | DS | xx-xx90 | 1 | Final Phase sacrifice | TERMINAL SACRIFICE | 1996-02-06 | 28 | 28 |
2 | 840522 | DS | xx-xx91 | 2 | Final Phase sacrifice | TERMINAL SACRIFICE | 1996-02-06 | 28 | 28 |
3 | 840522 | DS | xx-xx92 | 3 | Removed for washout | REMOVED FROM STUDY ALIVE | 1996-02-06 | 28 | 28 |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
DOMAIN | Domain Abbreviation | Char | BW | Identifier | Two-character abbreviation for the domain. | Req |
USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | |
BWSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | |
BWTESTCD | Test Short Name | Char | Topic | Short name of the measurement, test, or examination described in BWTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in BWTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). BWTESTCD cannot contain characters other than letters, numbers, or underscores. | Req | |
BWTEST | Test Name | Char | Synonym Qualifier | Long name for BWTESTCD. The value in BWTEST cannot be longer than 40 characters. | Req | |
BWORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp | |
BWORRESU | Unit of the Original Result | Char | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology list. | Exp | |
BWSTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from BWORRES in a standard format or standard units. BWSTRESC should store all results or findings in character format; if results are numeric, they should also be submitted in numeric format in BWSTRESN. | Exp | |
BWSTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of BWSTRESC. BWSTRESN should store all numeric test results or findings. | Exp |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
BWSTRESU | Unit of the Standardized Result | Char | Variable Qualifier | Standardized unit used for BWSTRESC and BWSTRESN. | Exp | |
BWSTAT | Completion Status | Char | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in BWORRES. | Perm | |
BWREASND | Reason Not Done | Char | Record Qualifier | Describes why BWSTAT is NOT DONE, such as BROKEN EQUIPMENT or TECHNICIAN OVERSIGHT. | Perm | |
BWBLFL | Baseline Flag | Char | Record Qualifier | A baseline indicator may be used to calculate differences or changes from baseline. Value should be Y or null. The baseline flag is sponsor defined. | Exp | |
BWFAST | Fasting Status | Char | Record Qualifier | Indicator used to identify fasting status. The value should by Y or null. | Perm | |
BWEXCLFL | Exclusion Flag | Char | Record Qualifier | Y if the result should be excluded from all calculations, otherwise null. | Perm | |
BWREASEX | Reason for Exclusion | Char | Record Qualifier | The reason the result should be excluded from all calculations. Used only when BWEXCLFL is Y. | Perm | |
BWUSCHFL | Unscheduled Flag | Char | Record Qualifier | Indicates whether the timing of a performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null. | Perm | |
VISITDY | Planned Study Day of Collection | Num | Timing | Planned study day of collection. Should be an integer. | Perm | |
BWDTC | Date/Time Animal Weighed | Char | ISO 8601 | Timing | Date/Time of body weight collection in ISO 8601 format. | Exp |
BWDY | Study Day Animal Weighed | Num | Timing | Study day of body weight collection, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | |
BWNOMDY | Nominal Study Day for Tabulations | Num | Timing | Nominal study day used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer. | Exp | |
BWNOMLBL | Label for Nominal Study Day | Char | Timing | A label for a given value of BWNOMDY as presented in the study report. Examples: "Week 4," "Day 28," "Terminal Sac". | Perm |
Assumptions for Body Weight (BW) Domain Model
Definition: The Body Weight (BW) domain captures body weights collected for subjects during the study and at the end of the study (terminal body weights).
Body weight gains are submitted in the Body Weight Gain (BG) domain.
Examples for Body Weight (BW) Domain Model
Example 1
This example shows body weights collected at weekly intervals, including some records showing when the collection was not done. In addition, some records were marked as excluded from all calculations due to being out of the normal range for the test.
bw.xpt
Row | STUDYID | DOMAIN | USUBJID | BWSEQ | BWTESTCD | BWTEST | BWORRES | BWORRESU | BWSTRESC | BWSTRESN | BWSTRESU | BWSTAT | BWREASND | BWBLFL | BWFAST | BWEXCLFL | BWREASEX | BWUSCHFL | BWDTC | BWDY | BWNOMDY | BWNOMLBL |
1 | ABC | BW | ABC-001- 001 | 1 | BW | Body Weight | 250 | g | 250 | 250 | g | Y | 1999- 06-19 | 1 | 1 | Week 1 | ||||||
2 | ABC | BW | ABC-001- 001 | 2 | BW | Body Weight | 240 | g | 240 | 240 | g | 1999- 06-26 | 8 | 8 | Week 2 | |||||||
3 | ABC | BW | ABC-001- 001 | 3 | BW | Body Weight | 280 | g | 280 | 280 | g | 1999- 07-03 | 15 | 15 | Week 3 | |||||||
4 | ABC | BW | ABC-001- 001 | 4 | BW | Body Weight | 190 | g | 190 | 190 | g | Y | Y | FASTING BY HUMAN ERROR | 1999- 07-10 | 22 | 22 | Week 4 | ||||
5 | ABC | BW | ABC-001- 001 | 5 | BW | Body Weight | 225 | g | 225 | 225 | g | 1999- 07-17 | 29 | 29 | Week 5 | |||||||
6 | ABC | BW | ABC-001- 001 | 6 | BW | Body Weight | 245 | g | 245 | 245 | g | 1999- 07-24 | 36 | 36 | Week 6 | |||||||
7 | ABC | BW | ABC-001- 001 | 7 | BW | Body Weight | 50 | g | 50 | 50 | g | Y | FAULTY EQUIPMENT | 1999- 07-31 | 43 | 43 | Week 7 | |||||
8 | ABC | BW | ABC-001- 001 | 8 | BW | Body Weight | 260 | g | 260 | 260 | g | 1999- 08-07 | 50 | 50 | Week 8 | |||||||
9 | ABC | BW | ABC-001- 001 | 9 | BW | Body Weight | NOT DONE | TECHNICIAN OVERSIGHT | 1999- 08-14 | 57 | 57 | Week 9 | ||||||||||
10 | ABC | BW | ABC-001- 001 | 10 | BW | Body Weight | 229 | g | 229 | 229 | g | 1999- 08-21 | 64 | 64 | Week 10 | |||||||
11 | ABC | BW | ABC-001- 001 | 11 | BW | Body Weight | 243 | g | 243 | 243 | g | 1999- 08-28 | 71 | 71 | Week 11 | |||||||
12 | ABC | BW | ABC-001- 001 | 12 | TERMBW | Terminal Body Weight | 225 | g | 225 | 225 | g | Y | 1999- 09-04 | 78 | 78 | |||||||
13 | ABC | BW | ABC-001- 010 | 1 | BW | Body Weight | 237 | g | 237 | 237 | g | Y | 1999- 07-03 | 15 | 15 | Unscheduled |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
DOMAIN | Domain Abbreviation | Char | BG | Identifier | Two-character abbreviation for the domain. | Req |
USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | |
BGSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | |
BGTESTCD | Test Short Name | Char | Topic | Short name of the measurement, test, or examination described in BGTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in BGTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). BGTESTCD cannot contain characters other than letters, numbers, or underscores. | Req | |
BGTEST | Test Name | Char | Synonym Qualifier | Long name for BGTESTCD. The value in BGTEST cannot be longer than 40 characters. | Req | |
BGORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp | |
BGORRESU | Unit of the Original Result | Char | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology (http://www.cdisc.org/terminology) list. | Exp | |
BGSTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from BGORRES in a standard format or standard units. BGSTRESC should store all results or findings in character format; if results are numeric, they should also be submitted in numeric format in BGSTRESN. | Exp | |
BGSTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of BGSTRESC. BGSTRESN should store all numeric test results or findings. | Exp | |
BGSTRESU | Unit of the Standardized Result | Char | Variable Qualifier | Standardized unit used for BGSTRESC and BGSTRESN. | Exp | |
BGSTAT | Completion Status | Char | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in BGORRES. | Perm | |
BGREASND | Reason Not Done | Char | Record Qualifier | Describes why BGSTAT is NOT DONE, such as MISSING BODY WEIGHT. | Perm | |
BGEXCLFL | Exclusion Flag | Char | Record Qualifier | Y if the result should be excluded from all calculations, otherwise null. | Perm | |
BGREASEX | Reason for Exclusion | Char | Record Qualifier | The reason the result should be excluded from all calculations. Used only when BGEXCLFL is Y. | Perm | |
BGDTC | Date/Time Animal Weighed | Char | ISO 8601 | Timing | Date/Time of the start of the weight interval, in ISO 8601 format. | Exp |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
BGENDTC | End Date/Time Animal Weighed | Char | ISO 8601 | Timing | Date/Time of the end of the weight interval, in ISO 8601 format. | Exp |
BGDY | Study Day of Start of Interval | Num | Timing | Study day of the start of the weight interval, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | |
BGENDY | Study Day of End of Weight Interval | Num | Timing | Study day of the end of the weight interval, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm |
Assumptions for Body Weight Gain (BG) Domain Model
Definition: Body weight gain is the actual difference between 2 body weight measurements for any given interval for a subject. This is most commonly shown as the difference between 2 consecutive body weight measurements.
Additional BGTEST/BGTESTCD values may be used for alternative representations of body weight gain measurements (e.g., percentage gain, average gain).
BGORRESU may change over the course of the study (e.g., g to kg), but BGSTRESU should remain consistent throughout the course of the study.
If 1 of the 2 body weights needed for the calculation is missing, BGSTAT should be "NOT DONE," and BGREASND could be "MISSING BODY WEIGHT."
If 1 of the 2 body weights needed for the calculation has an exclusion flag, then the corresponding BG values should also have BGEXCL = "Y". The BGREASEX value should be "EXCLUDED BODY WEIGHT".
Note that the BGDTC and BGENDTC variables are used for the start and end of the period as described in Section 4.4.6, Representing Timing in a Findings Domain.
Examples for Body Weight Gain (BG) Domain Model
Example 1
bg.xpt
Row | STUDYID | DOMAIN | USUBJID | BGSEQ | BGTESTCD | BGTEST | BGORRES | BGORRESU | BGSTRESC | BGSTRESN | BGSTRESU | BGSTAT | BGREASND | BGEXCLFL | BGREASEX | BGDTC | BGENDTC | BGDY | BGENDY |
1 | ABC | BG | ABC-001- 001 | 1 | BWGAIN | Body Weight Gain | 58.3 | g | 58.3 | 58.3 | g | 2008-04- 27 | 2008-05- 04 | 1 | 8 | ||||
2 | ABC | BG | ABC-001- 001 | 2 | BWGAIN | Body Weight Gain | 43.0 | g | 43.0 | 43.0 | g | 2008-05- 04 | 2008-05- 11 | 8 | 15 | ||||
3 | ABC | BG | ABC-001- 001 | 3 | BWGAIN | Body Weight Gain | 62.2 | g | 62.2 | 62.2 | g | 2008-05- 11 | 2008-05- 18 | 15 | 22 | ||||
4 | ABC | BG | ABC-001- 001 | 4 | BWGAIN | Body Weight Gain | 15.1 | g | 15.1 | 15.1 | g | Y | EXCLUDED BODY WEIGHT | 2008-05- 18 | 2008-05- 25 | 22 | 29 | ||
5 | ABC | BG | ABC-001- 001 | 5 | BWGAIN | Body Weight Gain | 48.8 | g | 48.8 | 48.8 | g | Y | EXCLUDED BODY WEIGHT | 2008-05- 25 | 2008-06- 01 | 29 | 36 | ||
6 | ABC | BG | ABC-001- 001 | 6 | BWGAIN | Body Weight Gain | 44.4 | g | 44.4 | 44.4 | g | 2008-06- 01 | 2008-06- 08 | 36 | 43 | ||||
7 | ABC | BG | ABC-001- 001 | 7 | BWGAIN | Body Weight Gain | -5.1 | g | -5.1 | -5.1 | g | 2008-06- 08 | 2008-06- 15 | 43 | 50 | ||||
8 | ABC | BG | ABC-001- 001 | 8 | BWGAIN | Body Weight Gain | NOT DONE | MISSING BODY WEIGHT | 2008-06- 15 | 50 | |||||||||
9 | ABC | BG | ABC-001- 001 | 9 | BWGAIN | Body Weight Gain | NOT DONE | MISSING BODY WEIGHT | 2008-06- 29 | 64 | |||||||||
10 | ABC | BG | ABC-001- 001 | 10 | BWGAIN | Body Weight Gain | 25.1 | g | 25.1 | 25.1 | g | 2008-06- 29 | 2008-07- 06 | 64 | 71 | ||||
11 | ABC | BG | ABC-001- 001 | 11 | BWGAIN | Body Weight Gain | 27.8 | g | 27.8 | 27.8 | g | 2008-07- 06 | 2008-07- 13 | 71 | 78 |
Example 2
bg.xpt
Row | STUDYID | DOMAIN | USUBJID | BGSEQ | BGTESTCD | BGTEST | BGORRES | BGORRESU | BGSTRESC | BGSTRESN | BGSTRESU | BGDTC | BGENDTC | BGDY | BGENDY |
1 | ABC | BG | ABC-001-001 | 1 | BWGAIN | Body Weight Gain | 58.3 | g | 58.3 | 58.3 | g | 2008-04-27 | 2008-05-04 | 1 | 8 |
2 | ABC | BG | ABC-001-001 | 2 | BWGAINA | Average Body Weight Gain | 8.3 | g/day | 8.3 | 8.3 | g/day | 2008-04-27 | 2008-05-04 | 1 | 8 |
3 | ABC | BG | ABC-001-001 | 3 | BWGAINP | Percentage Body Weight Gain | 16.7 | % | 16.7 | 16.7 | % | 2008-04-27 | 2008-05-04 | 1 | 8 |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
DOMAIN | Domain Abbreviation | Char | CL | Identifier | Two-character abbreviation for the domain. | Req |
USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Either USUBJID or POOLID must be populated. | Exp | |
POOLID | Pool Identifier | Char | Identifier | Identifier used for pooling subjects to assign a single finding to multiple subjects. If POOLID is entered, POOLDEF records must exist for each subject and the USUBJID must be null. Either USUBJID or POOLID must be populated. | Perm | |
FOCID | Focus of Study- Specific Interest | Char | Identifier | Identification of a focus of study-specific interest on or within a subject or specimen as defined in the protocol, for which a measurement, test, or examination was performed. An example could be a drug application site, e.g. "Injection site 1," "Biopsy site 1," "Treated site 1." the value in this variable should have inherent semantic value. | Perm | |
CLSEQ | Sequence Number | Num | Identifier | The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record. | Req | |
CLGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject or pool. This is not the treatment group number. | Perm | |
CLSPID | Mass Identifier | Char | Identifier | Mass identifier such as MASS 1 or MASS A. Used when the mass was discovered during the in-life phase and assigned a mass identifier. The mass identification should be unique within the subject, regardless of mass location. | Perm | |
CLTESTCD | Test Short Name | Char | Topic | Short name of the measurement, test, or examination described in CLTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in CLTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). CLTESTCD cannot contain characters other than letters, numbers, or underscores. | Req | |
CLTEST | Test Name | Char | Synonym Qualifier | Long name for CLTESTCD. The value in CLTEST cannot be longer than 40 characters. | Req | |
CLCAT | Category for Clinical Observations | Char | Grouping Qualifier | Used to define a category of the clinical observation. | Req | |
CLSCAT | Subcategory for Clinical Observations | Char | Grouping Qualifier | Used to further categorize a group of clinical observations within a category. For example "Whole Body Appearance" and "Sensory Organ Appearance" may be subcategories within Clinical Signs. | Perm | |
CLBODSYS | Body System or Organ Class | Char | Record Qualifier | Body system or organ class associated with the measurement performed. | Perm | |
CLORRES | Result or Findings as Collected | Char | Result Qualifier | Text description of the finding as originally received or collected. If the examination was not performed on a particular body system, or at the subject level, then the value should be null, and NOT DONE should appear in CLSTAT. | Exp |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
CLSTRESC | Standardized Result in Character Format | Char | Result Qualifier | The base finding from CLORRES without modifiers. If the examination was completed and there were no abnormal findings, the value must be NORMAL. | Exp | |
CLRESCAT | Result Category | Char | Variable Qualifier | Used to categorize the result of a finding post collection. Examples: Color or Facial. | Perm | |
CLSTAT | Completion Status | Char | Record Qualifier | Used to indicate examination not done or result is missing. Should be null if a result exists in CLORRES. | Perm | |
CLREASND | Reason Not Done | Char | Record Qualifier | Describes why CLSTAT is NOT DONE, such as SUBJECT MORIBUND. | Perm | |
CLLOC | Location of a Finding | Char | Record Qualifier | Can be used to specify where a clinical sign occurred. Example: LEFT EAR for skin rash. | Exp | |
CLEVAL | Evaluator | Char | Record Qualifier | Role of the person who provided the evaluation. Example: TOX TECHNICIAN, OPHTHALMOLOGIST, VETERINARIAN. | Perm | |
CLSEV | Severity | Char | Record Qualifier | Describes the severity or intensity of a particular finding. | Perm | |
CLEXCLFL | Exclusion Flag | Char | Record Qualifier | Y if the result should be excluded from all calculations, otherwise null. | Perm | |
CLREASEX | Reason for Exclusion | Char | Record Qualifier | The reason the result should be excluded from all calculations. Used only when CLEXCLFL is Y. | Perm | |
CLUSCHFL | Unscheduled Flag | Char | Record Qualifier | Indicates whether the timing of a performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null. | Perm | |
VISITDY | Planned Study Day of Collection | Num | Timing | Planned study day of collection. Should be an integer. | Perm | |
CLDTC | Date/Time of Observation | Char | ISO 8601 | Timing | Date/Time of the clinical observation in ISO 8601 format. For measurements related to a continuous evaluation interval, CLDTC should be used to indicate the start date/time of that interval. | Exp |
CLENDTC | End Date/Time of Observation | Char | ISO 8601 | Timing | Date/Time of end of observation interval, in ISO 8601 format. Should be populated when CLDTC represents the start date/time of a continuous evaluation interval. | Perm |
CLDY | Study Day of Observation | Num | Timing | Study day of observation, in integer days. For measurements related to a continuous evaluation interval, CLDY can be used to indicate start day of that interval. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | |
CLENDY | Study Day of End of Observation | Num | Timing | Study day of the end of observation, in integer days. Can be populated when CLDY represents the start day of a continuous evaluation interval. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | |
CLNOMDY | Nominal Study Day for Tabulations | Num | Timing | Nominal study day used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer. | Exp | |
CLNOMLBL | Label for Nominal Study Day | Char | Timing | A label for a given value of CLNOMDY as presented in the study report. Examples: "Week 4," "Day 28," "Terminal Sac". | Perm | |
CLTPT | Planned Time Point Name | Char | Timing | Text description of time when an observation should be taken, as defined in the protocol. This may be represented as an elapsed time relative to a fixed reference point, such as time postdose. | Perm |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
CLTPTNUM | Planned Time Point Number | Num | Timing | Numerical version of CLTPT to aid in sorting. | Perm | |
CLELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 | Timing | Planned Elapsed time (in ISO 8601 format) relative to a planned reference (CLTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: "- PT15M" to represent the period of 15 minutes prior to the reference point indicated by CLTPTREF, or "PT8H" to represent the period of 8 hours after the reference point indicated by CLTPTREF. | Perm |
CLTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by CLELTM, if used for CLTPTNUM, and CLTPT. It is recommended that CLTPTREF be as descriptive as possible, so the reference time point can be inferred without looking at other variables. Examples: PREVIOUS DOSE, PREVIOUS MEAL. | Perm | |
CLRFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 | Timing | Date/Time of the reference time point, CLTPTREF. | Perm |
Assumptions for Clinical Observations (CL) Domain Model
Definition: The Clinical Observations (CL) domain captures clinical sign information in addition to ophthalmology, physical examination, and dermal examination collected during the in-life phase of the study.
Categorization: CLSCAT, CLTESTCD, and CLTEST can be used by the sponsor to categorize data that were collected during in-life observation. CLCAT is fixed to the values specified in CDISC Controlled Terminology CLCAT list.
Results definition:
CLORRES contains the complete description of the clinical observation.
CLSTRESC should contain only the finding without modifiers. At this time it is not necessary to submit the additional modifiers elsewhere in this domain.
CLRESCAT is used for post-collection categorization of results and should not be a duplication of CLTEST or CLSCAT, which are considered categories at the time of collection.
The CLSPID variable is intended to reflect the identifier for any observed masses. This variable should be used to link in-life findings with pathology findings. The mass identifier in --SPID should be consistent across domains (CL, Palpable Masses, Macroscopic Findings, Microscopic Findings, and Tumor Findings).
Timing variables:
Information about the time of collection for any observation is needed to identify the record. CLDTC is expected, and the data will, in most cases, contain CLDTC, CLDY, or both. However, some studies (e.g., legacy studies) may not collect CLDTC or CLDY; in those cases, CLNOMDY must be populated.
CLTPT, CLTPTNUM, and CLELTM can be used when observations are made based on an elapsed time from a reference time point (e.g., 1 hour post-dose).
Examples for Clinical Observations (CL) Domain Model
Example 1
This example shows clinical signs captured in the collection system using categorization by CLSCAT or CLTEST. CLCAT is "CLINICAL SIGNS". CLTESTCD and CLTEST are used to capture the collection system's breakdown of observations. A comment record was included to clarify the time period for the tremors.
cl.xpt
Row | STUDYID | DOMAIN | USUBJID | CLSEQ | CLTESTCD | CLTEST | CLCAT | CLORRES | CLSTRESC | CLLOC | CLDTC | CLDY | CLNOMDY |
1 | 13456 | CL | 13456-01 | 1 | AG | Activity/Gait | CLINICAL SIGNS | Difficulty Walking | Difficulty Walking | 2003-01-20T15:44:42 | 7 | 7 | |
2 | 13456 | CL | 13456-01 | 2 | AC | Appearance and Condition | CLINICAL SIGNS | Pale | Pale | 2003-01-20T15:45:39 | 7 | 7 | |
3 | 13456 | CL | 13456-01 | 3 | EY | Eyes | CLINICAL SIGNS | Squinting | Squinting | 2003-01-20T15:45:55 | 7 | 7 | |
4 | 13456 | CL | 13456-02 | 1 | GO | General Observations | CLINICAL SIGNS | Salivation | Salivation | 2003-01-28T15:44:42 | 15 | 15 | |
5 | 13456 | CL | 13456-02 | 2 | GO | General Observations | CLINICAL SIGNS | Tremors; >10 mins | Tremors | 2003-01-28T15:44:42 | 15 | 15 | |
6 | 13456 | CL | 13456-03 | 1 | GO | General Observations | CLINICAL SIGNS | Normal | NORMAL | 2003-01-28T15:48:09 | 15 | 15 |
co.xpt
Row | STUDYID | DOMAIN | RDOMAIN | USUBJID | COSEQ | IDVAR | IDVARVAL | COVAL | CODTC |
1 | 13456 | CO | CL | 13456-02 | 1 | CLSEQ | 2 | Tremors did not cease while the technician was at the cage, which was a period of 10 minutes. |
Example 2
This example shows clinical signs captured in the collection system using no categorization by CLSCAT or CLTEST. CLTESTCD and CLTEST are also recorded as simply clinical signs.
cl.xpt
Row | STUDYID | DOMAIN | USUBJID | CLSEQ | CLTESTCD | CLTEST | CLCAT | CLORRES | CLSTRESC | CLLOC | CLDTC | CLDY | CLNOMDY |
1 | 13456 | CL | 13456-01 | 1 | CS | Clinical Sign | CLINICAL SIGNS | Difficulty Walking | Difficulty Walking | 2003-01-20T15:44:42 | 7 | 7 | |
2 | 13456 | CL | 13456-01 | 2 | CS | Clinical Sign | CLINICAL SIGNS | Pale | Pale | 2003-01-20T15:45:39 | 7 | 7 | |
3 | 13456 | CL | 13456-01 | 3 | CS | Clinical Sign | CLINICAL SIGNS | Squinting | Squinting | Both Eyes | 2003-01-20T15:45:55 | 7 | 7 |
4 | 13456 | CL | 13456-02 | 1 | CS | Clinical Sign | CLINICAL SIGNS | Salivation | Salivation | 2003-01-28T15:44:42 | 15 | 15 |
Row | STUDYID | DOMAIN | USUBJID | CLSEQ | CLTESTCD | CLTEST | CLCAT | CLORRES | CLSTRESC | CLLOC | CLDTC | CLDY | CLNOMDY |
5 | 13456 | CL | 13456-02 | 2 | CS | Clinical Sign | CLINICAL SIGNS | Tremors | Tremors | 2003-01-28T15:44:42 | 15 | 15 | |
6 | 13456 | CL | 13456-03 | 1 | CS | Clinical Sign | CLINICAL SIGNS | NAD | NORMAL | 2003-01-28T15:44:42 | 15 | 15 |
Example 3
This example shows clinical signs captured in the collection system using no categorization by CLCAT or CLTEST and having result categorization applied after collection for reporting purposes. CLTESTCD and CLTEST are recorded as simply "Clinical Sign", and CLRESCAT is used to categorize each result.
cl.xpt
Row | STUDYID | DOMAIN | USUBJID | CLSEQ | CLTESTCD | CLTEST | CLCAT | CLORRES | CLSTRESC | CLRESCAT | CLLOC | CLDTC | CLDY | CLNOMDY |
1 | 13456 | CL | 13456-01 | 1 | CS | Clinical Sign | CLINICAL SIGNS | Difficulty Walking | Difficulty Walking | CNS | 2003-01-20T15:44:42 | 7 | 7 | |
2 | 13456 | CL | 13456-01 | 2 | CS | Clinical Sign | CLINICAL SIGNS | Pale | Pale | Color | 2003-01-20T15:45:39 | 7 | 7 | |
3 | 13456 | CL | 13456-01 | 3 | CS | Clinical Sign | CLINICAL SIGNS | Squinting | Squinting | Facial | Both Eyes | 2003-01-20T15:45:55 | 7 | 7 |
4 | 13456 | CL | 13456-02 | 1 | CS | Clinical Sign | CLINICAL SIGNS | Salivation | Salivation | Facial | 2003-01-28T15:44:42 | 15 | 15 | |
5 | 13456 | CL | 13456-02 | 2 | CS | Clinical Sign | CLINICAL SIGNS | Tremors | Tremors | CNS | 2003-01-28T15:44:42 | 15 | 15 |
Example 4
This example shows clinical signs captured in the collection system using categorization by CLTEST and having result categorization applied after collection for reporting purposes. CLTESTCD and CLTEST are used to capture the collection system's breakdown of observations and CLRESCAT is used to categorize each result.
cl.xpt
Row | STUDYID | DOMAIN | USUBJID | CLSEQ | CLTESTCD | CLTEST | CLCAT | CLORRES | CLSTRESC | CLRESCAT | CLLOC | CLDTC | CLDY | CLNOMDY |
1 | 13456 | CL | 13456-01 | 1 | AG | Activity/Gait | CLINICAL SIGNS | Difficulty Walking | Difficulty Walking | CNS | 2003-01- 20T15:44:42 | 7 | 7 | |
2 | 13456 | CL | 13456-01 | 2 | AC | Appearance and Condition | CLINICAL SIGNS | Pale | Pale | Color | 2003-01- 20T15:45:39 | 7 | 7 | |
3 | 13456 | CL | 13456-01 | 3 | EY | Eyes | CLINICAL SIGNS | Squinting | Squinting | Facial | Both Eyes | 2003-01- 20T15:45:55 | 7 | 7 |
4 | 13456 | CL | 13456-02 | 1 | GO | General Observations | CLINICAL SIGNS | Salivation | Salivation | Facial | 2003-01- 28T15:44:42 | 15 | 15 | |
5 | 13456 | CL | 13456-02 | 2 | GO | General Observations | CLINICAL SIGNS | Tremors | Tremors | CNS | 2003-01- 28T15:44:42 | 15 | 15 |
Example 5
This example shows clinical signs captured in the collection system using categorization by CLSCAT or CLTEST. CLTESTCD and CLTEST are used to capture the collection system's breakdown of observations. CLSCAT further categorizes tests in the collection system.
cl.xpt
Row | STUDYID | DOMAIN | USUBJID | CLSEQ | CLTESTCD | CLTEST | CLCAT | CLSCAT | CLORRES | CLSTRESC | CLLOC | CLSEV | CLDTC | CLDY | CLNOMDY |
1 | 13456 | CL | 13456-01 | 1 | FE | Fur Examination | CLINICAL SIGNS | Whole Body Appearance | Piloerection, mild | Piloerection | Mild | 2003-01- 20T15:44:42 | 7 | 7 | |
2 | 13456 | CL | 13456-01 | 2 | FE | Fur Examination | CLINICAL SIGNS | Whole Body Appearance | Stained, yellow | Stained | 2003-01- 20T15:45:39 | 7 | 7 | ||
3 | 13456 | CL | 13456-01 | 3 | EE | Eye Examination | CLINICAL SIGNS | Sensory Organ Appearance | Red | Red | 2003-01- 20T15:45:55 | 7 | 7 | ||
4 | 13456 | CL | 13456-02 | 1 | FE | Fur Examination | CLINICAL SIGNS | Whole Body Appearance | Stained, yellow | Stained | 2003-01- 28T15:44:42 | 15 | 15 | ||
5 | 13456 | CL | 13456-02 | 2 | OE | Oral Examination | CLINICAL SIGNS | Sensory Organ Appearance | Missing tooth, right, bicuspid | Missing tooth | Right bicuspid | 2003-01- 28T15:44:42 | 15 | 15 |
Example 6
This example shows clinical signs captured in the collection system using categorization with CLCAT. CLTESTCD and CLTEST are simply "Clinical Signs" for all entries in this example. Examples show results for 2 animals caged together, so POOLID and not USUBJID is populated. The POOLDEF table (see Section 8.5.1, Pool Definition - POOLDEF) is shown below.
cl.xpt
Row | STUDYID | DOMAIN | USUBJID | POOLID | CLSEQ | CLTESTCD | CLTEST | CLCAT | CLORRES | CLSTRESC | CLLOC | CLSEV | CLDTC | CLDY | CLNOMDY |
1 | ABC1 | CL | CAGE1 | 1 | CS | Clinical Signs | CLINICAL SIGNS | Skin, Red, Pinna, Left | Skin, Red | Pinna, Left | 2003-01- 20T15:44:42 | 7 | 7 | ||
2 | ABC1 | CL | CAGE1 | 2 | CS | Clinical Signs | CLINICAL SIGNS | Fur, Thin Cover, Hindpaw, Left | Fur, Thin Cover | Hindpaw, Left | 2003-01- 20T15:45:39 | 7 | 7 | ||
3 | ABC1 | CL | CAGE1 | 3 | CS | Clinical Signs | CLINICAL SIGNS | Fur, Thin Cover, Hindpaw, Right | Fur, Thin Cover | Hindpaw, Right | 2003-01- 20T15:45:55 | 7 | 7 | ||
4 | ABC1 | CL | CAGE1 | 4 | CS | Clinical Signs | CLINICAL SIGNS | Conjunctival Hyperemia, Moderate | Conjunctival Hyperemia | Eye | MODERATE | 2003-01- 28T15:44:42 | 15 | 15 | |
5 | ABC1 | CL | CAGE1 | 5 | CS | Clinical Signs | CLINICAL SIGNS | Feces, Watery | Feces, Watery | 2003-01- 28T15:44:42 | 15 | 15 | |||
6 | ABC1 | CL | CAGE1 | 6 | CS | Clinical Signs | CLINICAL SIGNS | Feces, Mucoid | Feces, Mucoid | 2003-01- 28T15:44:42 | 15 | 15 | |||
7 | ABC1 | CL | CAGE1 | 7 | CS | Clinical Signs | CLINICAL SIGNS | Feces, Liquid (TS),Slight | Feces, Liquid | SLIGHT | 2003-01- 28T15:44:42 | 15 | 15 |
pooldef.xpt
Row | STUDYID | POOLID | USUBJID |
1 | ABC1 | CAGE1 | ABC1-1001 |
2 | ABC1 | CAGE1 | ABC1-1002 |
Example 7
This example shows clinical signs captured in the collection system using categorization. CLTESTCD and CLTEST are simply "Clinical Signs" for all entries in this example. Time points are included to indicate the signs that were taken for post-dose periods.
CLNOMLBL reflects the label that was used in the study report.
cl.xpt
Row | STUDYID | DOMAIN | USUBJID | CLSEQ | CLTESTCD | CLTEST | CLCAT | CLORRES | CLSTRESC | CLLOC | CLUSCHFL | CLDTC | CLDY | CLNOMDY | CLNOMLBL | CLTPT | CLTPTNUM |
1 | ABC1 | CL | ABC1- 1001 | 1 | CS | Clinical Signs | CLINICAL SIGNS | Skin, Red | Skin, Red | Pinna, Left | 2004-07- 19T07:21:39 | 7 | 7 | Day 7 | Postdose 1 | 1 | |
2 | ABC1 | CL | ABC1- 1001 | 2 | CS | Clinical Signs | CLINICAL SIGNS | Fur, Thin Cover | Fur, Thin Cover | Hindpaw, Left | 2004-07- 19T07:16:57 | 7 | 7 | Day 7 | Postdose 1 | 1 | |
3 | ABC1 | CL | ABC1- 1002 | 1 | CS | Clinical Signs | CLINICAL SIGNS | Fur, Thin Cover | Fur, Thin Cover | Hindpaw, Right | 2004-07- 19T07:27:01 | 7 | 7 | Day 7 | Postdose 1 | 1 | |
4 | ABC1 | CL | ABC1- 1001 | 3 | CS | Clinical Signs | CLINICAL SIGNS | Skin, Red | Skin, Red | Pinna, Left | 2004-07- 19T02:21:39 | 7 | 7 | Day 7 | Postdose 2 | 2 | |
5 | ABC1 | CL | ABC1- 1001 | 4 | CS | Clinical Signs | CLINICAL SIGNS | Fur, Thin Cover | Fur, Thin Cover | Hindpaw, Left | 2004-07- 19T02:16:57 | 7 | 7 | Day 7 | Postdose 2 | 2 | |
6 | ABC1 | CL | ABC1- 1002 | 2 | CS | Clinical Signs | CLINICAL SIGNS | Fur, Thin Cover | Fur, Thin Cover | Hindpaw, Right | Y | 2004-07- 19T04:15:01 | 7 | 7 | Day 7 Unscheduled |
Example 8
This example shows clinical signs categorized by CLTEST, with CLEVAL used to specify the role of the person who performed the examination. Physical examinations were captured in the collection system using categorization by CLTEST but not by CLCAT. CLTESTCD and CLTEST are used to capture the collection system's breakdown of observations.
cl.xpt
Row | STUDYID | DOMAIN | USUBJID | CLSEQ | CLTESTCD | CLTEST | CLCAT | CLORRES | CLSTRESC | CLLOC | CLEVAL | CLSEV | CLDTC | CLDY | CLNOMDY |
1 | 13456 | CL | 13456-01 | 1 | OE | Oral Examination | PHYSICAL EXAM | Teeth broken | Teeth broken | VET | 2005-12- 15T09:15:16 | 1 | 1 | ||
2 | 13456 | CL | 13456-01 | 2 | EA | External Appearance | PHYSICAL EXAM | Hordeolum, Mild, Right Eye | Hordeolum | Right Eye | VET | Mild | 2005-12- 15T09:20:42 | 1 | 1 |
3 | 13456 | CL | 13456-01 | 3 | EA | External Appearance | PHYSICAL EXAM | Material around eyes, Red, Left Eye | Material around eyes, Red | Left Eye | VET | 2005-12- 15T09:22:51 | 1 | 1 | |
4 | 13456 | CL | 13456-02 | 1 | PS | Pelage/Skin | PHYSICAL EXAM | Skin discolored | Skin discolored | VET | 2005-12- 16T07:02:58 | 2 | 2 | ||
5 | 13456 | CL | 13456-02 | 2 | RE | Respiration | PHYSICAL EXAM | Breathing difficult, Severe | Breathing difficult | VET | Severe | 2005-12- 16T07:02:58 | 2 | 2 |
Example 9
This example shows physical examinations captured in the collection system using categorization by CLTEST and having result categorization applied after collection for reporting purposes. CLTESTCD and CLTEST are used to capture the collection system's breakdown of observations, and CLRESCAT is used to categorize each result.
cl.xpt
Row | STUDYID | DOMAIN | USUBJID | CLSEQ | CLTESTCD | CLTEST | CLCAT | CLORRES | CLSTRESC | CLRESCAT | CLLOC | CLSEV | CLDTC | CLDY | CLNOMDY |
1 | 13456 | CL | 13456-01 | 1 | OE | Oral Examination | PHYSICAL EXAM | Teeth broken | Teeth broken | Facial | 2005-12- 15T09:15:16 | 1 | 1 | ||
2 | 13456 | CL | 13456-01 | 2 | EA | External Appearance | PHYSICAL EXAM | Hordeolum, Mild, Right Eye | Hordeolum | Facial | Right Eye | Mild | 2005-12- 15T09:20:42 | 1 | 1 |
3 | 13456 | CL | 13456-01 | 3 | EA | External Appearance | PHYSICAL EXAM | Material around eyes, Red, Left Eye | Material around eyes, Red | Facial | Left Eye | 2005-12- 15T09:22:51 | 1 | 1 | |
4 | 13456 | CL | 13456-02 | 1 | PS | Pelage/Skin | PHYSICAL EXAM | Skin discolored | Skin discolored | Skin | 2005-12- 16T07:02:58 | 2 | 2 | ||
5 | 13456 | CL | 13456-02 | 2 | RE | Respiration | PHYSICAL EXAM | Breathing difficult, Severe | Breathing difficult | Other | Severe | 2005-12- 16T07:02:58 | 2 | 2 |
Example 10
This example shows physical examinations captured in the collection system using categorization by CLSCAT. CLTESTCD and CLTEST are used to capture the collection system's breakdown of observations.
cl.xpt
Row | STUDYID | DOMAIN | USUBJID | CLSEQ | CLTESTCD | CLTEST | CLCAT | CLSCAT | CLORRES | CLSTRESC | CLLOC | CLSEV | CLDTC | CLDY | CLNOMDY |
1 | 13456 | CL | 13456-01 | 1 | OE | Oral Examination | PHYSICAL EXAM | Whole Body Appearance | Teeth broken | Teeth broken | 2005-12- 15T09:15:16 | 1 | 1 | ||
2 | 13456 | CL | 13456-01 | 2 | EA | Eye Examination | PHYSICAL EXAM | Whole Body Appearance | Hordeolum, Mild, Right Eye | Hordeolum | Right Eye | Mild | 2005-12- 15T09:20:42 | 1 | 1 |
3 | 13456 | CL | 13456-01 | 3 | EA | Eye Examination | PHYSICAL EXAM | Eye Appearance | Material around eyes, Red, Left Eye | Material around eyes, Red | Left Eye | 2005-12- 15T09:22:51 | 1 | 1 | |
4 | 13456 | CL | 13456-02 | 1 | FE | Fur Examination | PHYSICAL EXAM | Whole Body Appearance | Fur discolored | Fur discolored | 2005-12- 16T07:02:58 | 2 | 2 | ||
5 | 13456 | CL | 13456-02 | 2 | RE | Respiratory Examination | PHYSICAL EXAM | Respiration | Breathing difficult, Severe | Breathing difficult | Severe | 2005-12- 16T07:02:58 | 2 | 2 |
Example 11
This example shows ophthalmoscopic examinations captured in the collection system using no result categorization applied after collection for reporting purposes.
cl.xpt
Row | STUDYID | DOMAIN | USUBJID | CLSEQ | CLTESTCD | CLTEST | CLCAT | CLORRES | CLSTRESC | CLLOC | CLEVAL | CLSEV | CLDTC | CLDY | CLNOMDY |
1 | 13456 | CL | 13456-01 | 1 | OP | Ophthalmoscopic | OPHTHALMOLOGY | Nictitating | Nictitating | Left | OPHTHALMOLOGIST | 2005-12- | 1 | 1 | |
Examination | membrane | membrane | Eye | 15T09:15:16 | |||||||||||
protruding, Left | protruding | ||||||||||||||
Eye | |||||||||||||||
2 | 13456 | CL | 13456-01 | 2 | OP | Ophthalmoscopic | OPHTHALMOLOGY | Chorioretinal | Chorioretinal | Both | OPHTHALMOLOGIST | Moderate | 2005-12- | 1 | 1 |
Examination | hypoplasia, | hypoplasia | Eyes | 15T09:20:42 | |||||||||||
Moderate, Both | |||||||||||||||
Eyes | |||||||||||||||
3 | 13456 | CL | 13456-01 | 3 | OP | Ophthalmoscopic | OPHTHALMOLOGY | Conjunctivitis, | Conjunctivitis | Right | OPHTHALMOLOGIST | Mild | 2005-12- | 1 | 1 |
Examination | Mild, Right Eye | Eye | 15T09:22:51 | ||||||||||||
4 | 13456 | CL | 13456-02 | 1 | OP | Ophthalmoscopic | OPHTHALMOLOGY | Retinal | Retinal | Left | OPHTHALMOLOGIST | Severe | 2005-12- | 2 | 2 |
Examination | atrophy, | atrophy | Eye | 16T07:02:58 | |||||||||||
Severe, Left | |||||||||||||||
Eye | |||||||||||||||
5 | 13456 | CL | 13456-02 | 2 | OP | Ophthalmoscopic | OPHTHALMOLOGY | Iritis, Mild, Both | Iritis | Both | OPHTHALMOLOGIST | Mild | 2005-12- | 2 | 2 |
Examination | Eyes | Eyes | 16T07:02:58 |
Example 12
This example shows ophthalmoscopic examinations captured in the collection system using result categorization applied after collection for reporting purposes. CLTESTCD and CLTEST are used to capture the collection system's breakdown of observations.
cl.xpt
Row | STUDYID | DOMAIN | USUBJID | CLSEQ | CLTESTCD | CLTEST | CLCAT | CLORRES | CLSTRESC | CLRESCAT | CLLOC | CLSEV | CLDTC | CLDY | CLNOMDY |
1 | 13456 | CL | 13456-01 | 1 | OP | Ophthalmoscopic Examination | OPHTHALMOLOGY | Nictitating membrane protruding, Left Eye | Nictitating membrane protruding | Facial | Left Eye | 2005-12- 15T09:15:16 | 1 | 1 | |
2 | 13456 | CL | 13456-01 | 2 | OP | Ophthalmoscopic Examination | OPHTHALMOLOGY | Chorioretinal hypoplasia, Moderate, Both Eyes | Chorioretinal hypoplasia | Facial | Both Eyes | Moderate | 2005-12- 15T09:20:42 | 1 | 1 |
3 | 13456 | CL | 13456-01 | 3 | OP | Ophthalmoscopic Examination | OPHTHALMOLOGY | Conjunctivitis, Mild, Right Eye | Conjunctivitis | Facial | Right Eye | Mild | 2005-12- 15T09:22:51 | 1 | 1 |
4 | 13456 | CL | 13456-02 | 1 | OP | Ophthalmoscopic Examination | OPHTHALMOLOGY | Retinal atrophy, Severe, Left Eye | Retinal atrophy | Facial | Left Eye | Severe | 2005-12- 16T07:02:58 | 2 | 2 |
5 | 13456 | CL | 13456-02 | 2 | OP | Ophthalmoscopic Examination | OPHTHALMOLOGY | Iritis, Mild, Both Eyes | Iritis | Facial | Both Eyes | Mild | 2005-12- 16T07:02:58 | 2 | 2 |
Example 13
This example shows clinical signs captured in the collection system using categorization. CLTESTCD and CLTEST are simply "Clinical Signs" for all entries in this example. Reference time points are included to indicate that the signs being taken are for a certain duration post-dose.
cl.xpt
Row | STUDYID | DOMAIN | USUBJID | CLSEQ | CLTESTCD | CLTEST | CLCAT | CLORRES | CLSTRESC | CLLOC | CLDTC | CLDY | CLNOMDY | CLTPT | CLTPTNUM | CLELTM | CLTPTREF | CLRFTDTC |
1 | ABC1 | CL | ABC1- 1001 | 1 | CS | Clinical Signs | CLINICAL SIGNS | Skin, Red | Skin, Red | Pinna, Left | 2004-07- 19T07:21:39 | 1 | 1 | 15 minutes Postdose | 1 | PT15M | Day 1 Dose | 2004-07- 19T07:05:00 |
2 | ABC1 | CL | ABC1- 1001 | 2 | CS | Clinical Signs | CLINICAL SIGNS | Fur, Thin Cover | Fur, Thin Cover | Hindpaw, Left | 2004-07- 19T07:22:57 | 1 | 1 | 15 minutes Postdose | 1 | PT15M | Day 1 Dose | 2004-07- 19T07:05:00 |
3 | ABC1 | CL | ABC1- 1002 | 1 | CS | Clinical Signs | CLINICAL SIGNS | Fur, Thin Cover | Fur, Thin Cover | Hindpaw, Right | 2004-07- 19T07:27:01 | 1 | 1 | 15 minutes Postdose | 1 | PT15M | Day 1 Dose | 2004-07- 19T07:05:00 |
4 | ABC1 | CL | ABC1- 1001 | 3 | CS | Clinical Signs | CLINICAL SIGNS | Skin, Red | Skin, Red | Pinna, Left | 2004-07- 19T15:05:39 | 1 | 1 | 8 Hours Postdose | 2 | PT8H | Day 1 Dose | 2004-07- 19T07:05:00 |
5 | ABC1 | CL | ABC1- 1001 | 4 | CS | Clinical Signs | CLINICAL SIGNS | Fur, Thin Cover | Fur, Thin Cover | Hindpaw, Left | 2004-07- 19T15:05:57 | 1 | 1 | 8 Hours Postdose | 2 | PT8H | Day 1 Dose | 2004-07- 19T07:05:00 |
6 | ABC1 | CL | ABC1- 1002 | 2 | CS | Clinical Signs | CLINICAL SIGNS | Fur, Thin Cover | Fur, Thin Cover | Hindpaw, Right | 2004-07- 19T15:05:01 | 1 | 1 | 8 Hours Postdose | 2 | PT8H | Day 1 Dose | 2004-07- 19T07:05:00 |
Example 14
Clinical sign related to a finding in anther domain. This example shows 2 unrelated clinical signs: thinning fur on the left hindpaw and swelling seen on the animal that then was determined to be a mass. A RELREC example is used to tie the record for the mass to an MA record.
cl.xpt
Row | STUDYID | DOMAIN | USUBJID | CLSEQ | CLSPID | CLTESTCD | CLTEST | CLCAT | CLORRES | CLSTRESC | CLLOC | CLDTC | CLDY | CLNOMDY |
1 | PY001002 | CL | AA-12012 | 1065 | MASS1 | CS | Clinical Signs | CLINICAL SIGNS | Swelling; Left Jaw | Swelling | Left Jaw | 2004-07-19 | 42 | 42 |
2 | PY001002 | CL | AA-12012 | 1066 | CS | Clinical Signs | CLINICAL SIGNS | Fur, Thin Cover; Left Hindpaw | Fur, Thin Cover | Left Hindpaw | 2004-07-19 | 42 | 42 |
relrec.xpt
Row | STUDYID | RDOMAIN | USUBJID | POOLID | IDVAR | IDVARVAL | RELTYPE | RELID |
1 | PY001002 | CL | AA-12012 | CLSEQ | 1065 | 62 | ||
2 | PY001002 | MA | AA-12012 | MASEQ | 233 | 62 |
Example 15
This is an example for selected animals from a local toxicity study including where local tolerance assessment is the most important endpoint.
The identification of injection sites is carried throughout the study for all measurements performed across all domains. The values in FOCID would be expected to be used in Exposure (EX) to designate the dose administered at each injection site.
Note that the concept of "MASS 1" (in CLSPID) is different from "Injection site 1" (in FOCID); information in the FOCID variable is known prior to the start of the study, but the mass ID/sponsor identifier is assigned as part of the examination. FOCID thereby relates to the test, whereas CLSPID is related to the result.
cl.xpt
Row | STUDYID | DOMAIN | USUBJID | FOCID | CLSEQ | CLSPID | CLTESTCD | CLTEST | CLCAT | CLORRES | CLSTRESC | CLLOC | CLSEV | CLDTC | CLDY | CLNOMDY |
1 | 12345 | CL | 12345001 | Injection site 1 | 1 | SKINEX | Skin Examination | CLINICAL SIGNS | Fur, Thin Cover; Left Scapula | Fur, Thin Cover | Left Scapula | 2004-07-19 | 42 | 42 | ||
2 | 12345 | CL | 12345001 | Injection site 2 | 2 | SKINEX | Skin Examination | CLINICAL SIGNS | No Abnormal Findings, Right Scapula | NORMAL | Right Scapula | 2004-07-19 | 42 | 42 | ||
3 | 12345 | CL | 12345001 | Injection site 3 | 3 | SKINEX | Skin Examination | CLINICAL SIGNS | No Abnormal Findings, Left Medial Back | NORMAL | Left Medial Back | 2004-07-19 | 42 | 42 | ||
4 | 12345 | CL | 12345001 | Injection site 4 | 4 | MASS 1 | SKINEX | Skin Examination | CLINICAL SIGNS | Moderate Swelling, Right Medial Back | Swelling | Right Medial Back | MODERATE | 2004-07-19 | 42 | 42 |
5 | 12345 | CL | 12345002 | Injection site 1 | 1 | SKINEX | Skin Examination | CLINICAL SIGNS | No Abnormal Findings, Left Scapula | NORMAL | Left Scapula | 2004-07-19 | 42 | 42 | ||
6 | 12345 | CL | 12345002 | Injection site 2 | 2 | SKINEX | Skin Examination | CLINICAL SIGNS | Slight Reddening, Right Scapula | Reddening | Right Scapula | MILD | 2004-07-19 | 42 | 42 | |
7 | 12345 | CL | 12345002 | Injection site 3 | 3 | SKINEX | Skin Examination | CLINICAL SIGNS | Abrasion, Left Medial Back | Abrasion | Left Medial Back | 2004-07-19 | 42 | 42 | ||
8 | 12345 | CL | 12345002 | Injection site 4 | 4 | SKINEX | Skin Examination | CLINICAL SIGNS | Moderate Reddening, Right Medial Back | Reddening | Right Medial Back | MODERATE | 2004-07-19 | 42 | 42 |
Example 16: Qualitative Food Consumption
This example shows multiple possibilities for presenting food consumption within the Clinical Observations domain when it is collected as text and reported as a qualitative measure.
Often when food consumption is collected qualitatively, it is done by exception: A record exists only when the value is not normal. "None" indicates that no feed was consumed, and "Low" indicates that the consumption was less than normal.
cl.xpt
Row | STUDYID | DOMAIN | USUBJID | CLSEQ | CLTESTCD | CLTEST | CLCAT | CLORRES | CLSTRESC | CLLOC | CLDTC | CLDY | CLNOMDY | CLTPT | CLTPTNUM |
1 | 123456 | CL | 12345-01 | 1 | QUALFC | Qualitative Food Consumption | CLINICAL SIGNS | Low | Low | 2003-01-20T15:44:42 | 3 | 3 | p.m. obs | 3 | |
2 | 123456 | CL | 12345-01 | 2 | QUALFC | Qualitative Food Consumption | CLINICAL SIGNS | Low | Low | 2003-01-21T15:45:39 | 4 | 4 | p.m. obs | 3 | |
3 | 123456 | CL | 12345-01 | 3 | QUALFC | Qualitative Food Consumption | CLINICAL SIGNS | None | None | 2003-01-22T08:26:32 | 5 | 5 | a.m. obs | 1 |
cl.xpt
Row | STUDYID | DOMAIN | USUBJID | CLSEQ | CLTESTCD | CLTEST | CLCAT | CLSCAT | CLORRES | CLSTRESC | CLLOC | CLUSCHFL | CLDTC | CLDY | CLNOMDY |
1 | 654321 | CL | 654321_101 | 1 | BEAC | BEHAVIOR/ACTIVITY | CLINICAL SIGNS | UNSCHEDULED | Inappetence | INAPPETENCE | Y | 2013-06-14T13:41:18 | 141 | 141 | |
2 | 654321 | CL | 654321_101 | 2 | BEAC | BEHAVIOR/ACTIVITY | CLINICAL SIGNS | ROUTINE | Inappetence | INAPPETENCE | 2013-06-15T08:01:10 | 142 | 142 |
This row shows a qualitative food consumption record collected as part of the protocol-specified afternoon check for signs of ill health or reaction to treatment. The CLSCAT shows the clinical sign subcategory, and the CLTPT indicates the specified collection timepoint.
cl.xpt
Row | STUDYID | DOMAIN | USUBJID | CLSEQ | CLTESTCD | CLTEST | CLCAT | CLSCAT | CLORRES | CLSTRESC | CLLOC | CLDTC | CLDY | CLNOMDY | CLTPT | CLTPTNUM |
1 | 321654 | CL | 321654-01 | 1 | CS | Clinical Signs | CLINICAL SIGNS | SIRT/Cage Observations | Reduced Appetite | Reduced Appetite | 2013-02-13T15:00:56 | 35 | 35 | PM SIRT | 3 |
In this example, food consumption activity is collected as part of the standard clinical signs and presented as qualitative assessment of the food consumption.
cl.xpt
Row | STUDYID | DOMAIN | USUBJID | CLSEQ | CLTESTCD | CLTEST | CLCAT | CLORRES | CLSTRESC | CLLOC | CLDTC | CLDY | CLNOMDY |
1 | 345612 | CL | 345612-1000 | 1 | EFC | Estimated Food Consumed | CLINICAL SIGNS | Food Qualitative 0% | Food Qualitative 0% | 2013-02-13T15:00:00 | 35 | 35 | |
2 | 345612 | CL | 345612-1001 | 2 | EFC | Estimated Food Consumed | CLINICAL SIGNS | Food Qualitative 50% | Food Qualitative 50% | 2013-02-13T15:01:00 | 35 | 35 | |
3 | 345612 | CL | 345612-1002 | 3 | EFC | Estimated Food Consumed | CLINICAL SIGNS | Food Qualitative 100% | Food Qualitative 100% | 2013-02-13T15:02:00 | 35 | 35 | |
4 | 345612 | CL | 345612-1003 | 4 | EFC | Estimated Food Consumed | CLINICAL SIGNS | Other (see comment) | Other (see comment) | 2013-02-13T15:03:00 | 35 | 35 |
Death Diagnosis and Details – DD
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
DOMAIN | Domain Abbreviation | Char | DD | Identifier | Two-character abbreviation for the domain. | Req |
USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | |
DDSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | |
DDTESTCD | Death Diagnosis Short Name | Char | Topic | Short name of the measurement, test, or examination described in DDTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in DDTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). DDTESTCD cannot contain characters other than letters, numbers, or underscores. | Req | |
DDTEST | Death Diagnosis Name | Char | Synonym Qualifier | Long name for DDTESTCD. The value in DDTEST cannot be longer than 40 characters. | Req | |
DDORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the diagnosis of the subject's cause of death, as originally received or collected. | Req | |
DDSTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the diagnosis information, copied or derived from DDORRES in a standard format. Examples: UNKNOWN, GAVAGE ERROR. | Exp | |
DDRESCAT | Result Category | Char | Variable Qualifier | Used to categorize the result of a finding. Examples: TREATMENT RELATED, NONTREATMENT RELATED, UNDETERMINED, ACCIDENTAL, etc. | Perm | |
DDEVAL | Evaluator | Char | Record Qualifier | Role of the person who provided the evaluation. Examples: TOX PATHOLOGIST, PEER REVIEW, SPONSOR, VETERINARIAN. | Perm | |
DDDTC | Date/Time | Char | ISO 8601 | Timing | The date/time of subject disposition, in ISO 8601 format. | Perm |
DDDY | Study Day | Num | Timing | Study day of subject disposition, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm |
Assumptions for Death Diagnosis and Details (DD) Domain Model
The Death Diagnosis and Details (DD) domain captures the diagnosis of the cause of death for a subject.
No records will be present for subjects where a cause of death was not collected. The DD domain should be utilized only for subjects with an unscheduled death. This may include moribund subjects, subjects found dead, accidental deaths, and so on.
The DD domain will not include findings of "planned sacrifice" or other scheduled reasons for termination.
The information in this domain may duplicate "death relationship" information in other domains. The cause of death will be explicitly presented here if available, even when a --DTHREL implies cause of death in another domain.
Examples for Death Diagnosis And Details (DD) Domain Model
Example 1
This example shows sample death diagnosis findings.
dd.xpt
Row | STUDYID | DOMAIN | USUBJID | DDSEQ | DDTESTCD | DDTEST | DDORRES | DDSTRESC | DDDTC | DDDY |
1 | 123456 | DD | 123456-1001 | 1 | DEATHD | Death Diagnosis | SYSTEMIC: Gastric reflux | Gastric reflux | 1996-03-06 | 360 |
2 | 123456 | DD | 123456-1002 | 1 | DEATHD | Death Diagnosis | MUSCULOSKELETAL MISCELLANEOUS: Inflammation, SEVERE | Inflammation | 1996-03-02 | 356 |
3 | 123456 | DD | 123456-1003 | 1 | DEATHD | Death Diagnosis | SYSTEMIC: Amyloidosis | Amyloidosis | 1996-03-05 | 359 |
Example 2
This example shows the use of additional permissible variables.
dd.xpt
Row | STUDYID | DOMAIN | USUBJID | DDSEQ | DDTESTCD | DDTEST | DDORRES | DDSTRESC | DDRESCAT | DDEVAL | DDDTC | DDDY |
1 | 840516 | DD | xx-xx82 | 1 | DEATHD | Death Diagnosis | Broken Neck | Spinal Column, Severed | ACCIDENTAL | NECROPSY SUPERVISOR | 1996-02- 06 | 329 |
2 | 840516 | DD | xx-xx83 | 1 | DEATHD | Death Diagnosis | Clonic Convulsions | Clonic Convulsions | TREATMENT RELATED | VETERINARIAN | 1996-03- 05 | 358 |
Food and Water Consumption – FW
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
DOMAIN | Domain Abbreviation | Char | FW | Identifier | Two-character abbreviation for the domain. | Req |
USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Either USUBJID or POOLID must be populated. | Exp | |
POOLID | Pool Identifier | Char | Identifier | Identifier used for pooling subjects to assign a single finding to multiple subjects. If POOLID is entered, POOLDEF records must exist for each subject and the USUBJID must be null. Either USUBJID or POOLID must be populated. | Perm | |
FWSEQ | Sequence Number | Num | Identifier | The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record. | Req |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
FWGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject or pool. This is not the treatment group number. | Perm | |
FWTESTCD | Food/Water Consumption Short Name | Char | Topic | Short name of the measurement, test, or examination described in FWTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in FWTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). FWTESTCD cannot contain characters other than letters, numbers, or underscores. Extensible controlled values are FC, FCRELBW, WC, and WCRELBW. | Req | |
FWTEST | Food/Water Consumption Name | Char | Synonym Qualifier | Long name for FWTESTCD. The value in FWTEST cannot be longer than 40 characters. Extensible controlled values are Food Consumption, Food Consumption Relative to Body Wt, Water Consumption, Water Consumption Relative to Body Wt. | Req | |
FWORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp | |
FWORRESU | Unit of the Original Result | Char | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology (http://www.cdisc.org/terminology) list. | Exp | |
FWSTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from FWORRES, in a standard format or standard units. FWSTRESC should store all results or findings in character format; if results are numeric, they should also be submitted in numeric format in FWSTRESN. | Exp | |
FWSTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of FWSTRESC. FWSTRESN should store all numeric test results or findings. | Exp | |
FWSTRESU | Unit of the Standardized Result | Char | Variable Qualifier | Standardized unit used for FWSTRESC and FWSTRESN. | Exp | |
FWSTAT | Completion Status | Char | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in FWORRES. | Perm | |
FWREASND | Reason Not Done | Char | Record Qualifier | Describes why FWSTAT is NOT DONE, such as FOOD WET. | Perm | |
FWEXCLFL | Exclusion Flag | Char | Record Qualifier | Y if the result should be excluded from all calculations, otherwise null. | Perm | |
FWREASEX | Reason for Exclusion | Char | Record Qualifier | The reason the result should be excluded from all calculations. Used only when FWEXCLFL is Y. | Perm | |
FWDTC | Start Date/Time of Observation | Char | ISO 8601 | Timing | Date/Time of the start of the observation in IS0 8601 format. | Exp |
FWENDTC | End Date/Time of Observation | Char | ISO 8601 | Timing | Date/Time of the end of the observation in IS0 8601 format. | Exp |
FWDY | Study Day of Start of Observation | Num | Timing | Study day of the start of the observation, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | |
FWENDY | Study Day of End of Observation | Num | Timing | Study day of the end of the observation, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm |
Assumptions for Food and Water Consumption (FW) Domain Model
The Food and Water Consumption (FW) domain captures food/water consumption of subjects in the study. The data in this domain are derived data.
POOLID is used when a single finding may be collected for multiple subjects using POOLID (e.g., group-housed subjects).
The reported results may be in units defined per subject or per cage, and the corresponding FWSTRESU must reflect whether the reported result is per subject or per cage.
The FWSTRESC and FWSTRESN must have the appropriate units when they represent a calculation: */animal/* — (e.g., g/animal/day, g/animal/week; kg/animal/day, kg/animal/week).
FWDTC and FWENDTC variables, if applicable, are used as described in Section 4.4.6, Representing Timing in a Findings Domain.
Examples for Food And Water Consumption (FW) Domain Model
Example 1
This example shows when the data collection system stores the calculated food consumption and water consumption (FWORRES) as "g" and "mL", and FWSTRESC and FWSTRESN reflect results in the standardized unit per animal per day.
fw.xpt
Row | STUDYID | DOMAIN | USUBJID | POOLID | FWSEQ | FWTESTCD | FWTEST | FWORRES | FWORRESU | FWSTRESC | FWSTRESN | FWSTRESU | FWDTC | FWENDTC | FWDY | FWENDY |
1 | 13456 | FW | C1-101- 102 | 1 | FC | Food Consumption | 400 | g | 28.6 | 28.6 | g/animal/day | 2003- 01-20 | 2003-01- 27 | 1 | 7 | |
2 | 13456 | FW | C1-201- 202 | 2 | FC | Food Consumption | 300 | g | 21.4 | 21.4 | g/animal/day | 2003- 01-20 | 2003-01- 27 | 1 | 7 | |
3 | 13456 | FW | C1-101- 102 | 3 | WC | Water Consumption | 210 | mL | 15.0 | 15.0 | mL/animal/day | 2003- 01-20 | 2003-01- 27 | 1 | 7 | |
4 | 13456 | FW | C1-201- 202 | 4 | WC | Water Consumption | 276 | mL | 34.5 | 34.5 | mL/animal/day | 2003- 01-23 | 2003-01- 27 | 3 | 7 |
pooldef.xpt
Row | STUDYID | POOLID | USUBJID |
1 | 13456 | C1-101-102 | ABC1-101 |
2 | 13456 | C1-101-102 | ABC1-102 |
3 | 13456 | C1-201-202 | ABC1-201 |
4 | 13456 | C1-201-202 | ABC1-202 |
Example 2
Row 3: Shows Animals 301 and 302 housed together, and POOLDEF Rows 5-6 show Animals 301 and 302 as a pool C1-301-302. Note that the collection period was only 3 days, and a conversion was made to g/animal/week.
Row 4: Animal 301 died. Therefore, the USUBJID is not populated and a new POOLID is generated as demonstrated in POOLDEF Row 7. Note that the collection period was only 4 days, and a conversion was made to g/animal/week.
fw.xpt
Row | STUDYID | DOMAIN | USUBJID | POOLID | FWSEQ | FWTESTCD | FWTEST | FWORRES | FWORRESU | FWSTRESC | FWSTRESN | FWSTRESU | FWDTC | FWENDTC | FWDY | FWENDY |
1 | 13456 | FW | C1-101-102 | 1 | FC | Food Consumption | 400 | g | 200 | 200 | g/animal/week | 2003-01-20T15:44:42 | 2003-01-27T15:43:47 | 1 | 8 | |
2 | 13456 | FW | C1-201-202 | 2 | FC | Food Consumption | 420 | g | 210 | 210 | g/animal/week | 2003-01-20T15:44:42 | 2003-01-27T15:43:47 | 1 | 8 | |
3 | 13456 | FW | C1-301-302 | 3 | FC | Food Consumption | 176 | g | 205 | 205 | g/animal/week | 2003-01-20T15:44:42 | 2003-01-23T13:40:42 | 1 | 4 | |
4 | 13456 | FW | C1-302 | 4 | FC | Food Consumption | 69 | g | 120 | 120 | g/animal/week | 2003-01-23T13:40:42 | 2003-01-27T15:43:47 | 4 | 8 |
pooldef.xpt
Row | STUDYID | POOLID | USUBJID |
1 | 13456 | C1-101-102 | ABC1-101 |
2 | 13456 | C1-101-102 | ABC1-102 |
3 | 13456 | C1-201-202 | ABC1-201 |
4 | 13456 | C1-201-202 | ABC1-202 |
5 | 13456 | C1-301-302 | ABC1-301 |
6 | 13456 | C1-301-302 | ABC1-302 |
7 | 13456 | C1-302 | ABC1-302 |
Example 3
This example shows when the data collection system stores the FWORRES as the total cage consumption. Note that this is a variation on the data in Example 2.
fw.xpt
Row | STUDYID | DOMAIN | USUBJID | POOLID | FWSEQ | FWTESTCD | FWTEST | FWORRES | FWORRESU | FWSTRESC | FWSTRESN | FWSTRESU | FWDTC | FWENDTC | FWDY | FWENDY |
1 | 13456 | FW | C1-101-102 | 1 | FC | Food Consumption | 400 | g | 400 | 400 | g | 2003-01-20T15:44:42 | 2003-01-27T15:43:47 | 1 | 7 | |
2 | 13456 | FW | C1-201-202 | 2 | FC | Food Consumption | 420 | g | 420 | 420 | g | 2003-01-20T15:44:42 | 2003-01-27T15:43:47 | 1 | 7 | |
3 | 13456 | FW | C1-302 | 3 | FC | Food Consumption | 120 | g | 120 | 120 | g | 2003-01-20T15:44:42 | 2003-01-27T15:43:47 | 1 | 7 |
pooldef.xpt
Row | STUDYID | POOLID | USUBJID |
1 | 13456 | C1-101-102 | ABC1-101 |
2 | 13456 | C1-101-102 | ABC1-102 |
Row | STUDYID | POOLID | USUBJID |
3 | 13456 | C1-201-202 | ABC1-201 |
4 | 13456 | C1-201-202 | ABC1-202 |
5 | 13456 | C1-302 | ABC1-302 |
Example 4
This example shows when the data collection system stores FWORRES as the total cage consumption, and FWSTRESC and FWSTRESN are populated with a calculation of g/animal/week. In this example, the pools are defined at the start of each collection interval.
fw.xpt
Row | STUDYID | DOMAIN | USUBJID | POOLID | FWSEQ | FWTESTCD | FWTEST | FWORRES | FWORRESU | FWSTRESC | FWSTRESN | FWSTRESU | FWDTC | FWENDTC | FWDY | FWENDY |
1 | 13456 | FW | C1-101-102-103 | 1 | FC | Food Consumption | 400 | g | 165 | 165 | g/animal/week | 2003-01-20T15:44:42 | 2003-01-27T15:44:47 | 1 | 7 | |
2 | 13456 | FW | C1-101-103 | 2 | FC | Food Consumption | 280 | g | 140 | 140 | g/animal/week | 2003-01-28T15:45:43 | 2003-02-04T15:45:48 | 8 | 15 |
co.xpt
Row | STUDYID | DOMAIN | RDOMAIN | POOLID | COSEQ | IDVAR | IDVARVAL | COVAL |
1 | 13456 | CO | FW | C1-101-102-103 | 1 | FWSEQ | 1 | Animal 102 died unscheduled during the week. Food consumption was calculated based upon the number of days the animal was alive. |
pooldef.xpt
Row | STUDYID | POOLID | USUBJID |
1 | 13456 | C1-101-102-103 | ABC1-101 |
2 | 13456 | C1-101-102-103 | ABC1-102 |
3 | 13456 | C1-101-102-103 | ABC1-103 |
4 | 13456 | C1-101-103 | ABC1-101 |
5 | 13456 | C1-101-103 | ABC1-103 |
Example 5
This is an example of food consumption records for single-housed subjects.
fw.xpt
Row | STUDYID | DOMAIN | USUBJID | FWSEQ | FWTESTCD | FWTEST | FWORRES | FWORRESU | FWSTRESC | FWSTRESN | FWSTRESU | FWEXCLFL | FWEXREASEX | FWDTC | FWENDTC | FWDY | FWENDY |
1 | 123456 | FW | 12345- 101 | 1 | FC | Food Consumption | 220 | g | 220 | 220 | g | 2006-07- 19T12:17:26 | 2006-07- 19T16:05:47 | 1 | 1 | ||
2 | 123456 | FW | 12345- 101 | 2 | FCRELBW | Food Consumption Relative to Body Wt | 20.2 | g/kg | 20.2 | 20.2 | g/kg | 2006-12-29 | 2006-12-29 | 160 | 160 | ||
3 | 123456 | FW | 12345- 102 | 3 | FC | Food Consumption | 260 | g | 260 | 260 | g | Y | FOOD WET | 2006-07- 19T12:17:26 | 2006-07- 19T16:05:47 | 1 | 1 |
4 | 123456 | FW | 12345- 101 | 4 | WC | Water Consumption | 220 | mL | 220 | 220 | mL | 2006-07- 19T13:17:26 | 2006-07- 19T17:05:47 | 1 | 1 | ||
5 | 123456 | FW | 12345- 101 | 5 | WCRELBW | Water Consumption Relative to Body Wt | 20.2 | mL/kg | 20.2 | 20.2 | mL/kg | 2006-12-29 | 2006-12-29 | 160 | 160 |
Laboratory Test Results – LB
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
DOMAIN | Domain Abbreviation | Char | LB | Identifier | Two-character abbreviation for the domain. | Req |
USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all application or submissions involving the product. Either USUBJID or POOLID must be populated. | Exp | |
POOLID | Pool Identifier | Char | Identifier | Identifier used for pooling subjects to assign a single finding to multiple subjects. If POOLID is entered, POOLDEF records must exist for each subject and the USUBJID must be null. Either USUBJID or POOLID must be populated. | Perm | |
LBSEQ | Sequence Number | Num | Identifier | The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record. | Req | |
LBGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject or pool. This is not the treatment group number. | Perm | |
LBREFID | Specimen Identifier | Char | Identifier | Internal or external specimen identifier. Example: 1009570101. | Perm | |
LBSPID | Sponsor-Defined Identifier | Char | Identifier | Sponsor-defined reference identifier. Example: Line number on the Lab page. | Perm | |
LBTESTCD | Lab Test or Examination Short Name | Char | Topic | Short name of the measurement, test, or examination described in LBTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in LBTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). LBTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: ALT, LDH. | Req | |
LBTEST | Lab Test or Examination Name | Char | Synonym Qualifier | Long name for LBTESTCD. The value in LBTEST cannot be longer than 40 characters. Examples: Alanine Aminotransferase, Lactate Dehydrogenase. | Req | |
LBCAT | Category for Lab Test | Char | Grouping Qualifier | Used to define a category of the lab test performed. Examples: URINALYSIS, CLINICAL CHEMISTRY, HEMATOLOGY, etc. | Exp | |
LBSCAT | Subcategory for Lab Test | Char | Grouping Qualifier | A further categorization of a test category. Examples: DIFFERENTIAL, LIVER FUNCTION, ELECTROLYTES. | Perm | |
LBORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp | |
LBORRESU | Unit of the Original Result | Char | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology (http://www.cdisc.org/terminology) list. | Exp |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
LBORNRLO | Reference Range Lower Limit-Orig Unit | Char | Variable Qualifier | Lower end of reference range used at the time of collection for continuous measurements in original units. Should be populated only for continuous results. | Perm | |
LBORNRHI | Reference Range Upper Limit-Orig Unit | Char | Variable Qualifier | Upper end of reference range used at the time of collection for continuous measurements in original units. Should be populated only for continuous results. | Perm | |
LBSTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from LBORRES, in a standard format or standard units. LBSTRESC should store all results or findings in character format; if results are numeric, they should also be submitted in numeric format in LBSTRESN. For example, if a test has results NONE, NEG, and NEGATIVE in LBORRES and these results effectively have the same meaning, they could be represented in standard format in LBSTRESC as NEGATIVE. For other examples, see general assumptions. | Exp | |
LBSTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of LBSTRESC. LBSTRESN should store all numeric test results or findings. | Exp | |
LBSTRESU | Unit of the Standardized Result | Char | Variable Qualifier | Standardized unit used for LBSTRESC and LBSTRESN. | Exp | |
LBSTNRLO | Reference Range Lower Limit-Std Unit | Num | Variable Qualifier | Lower end of reference range for continuous measurements in standardized units. Should be populated only for continuous results. | Perm | |
LBSTNRHI | Reference Range Upper Limit-Std Unit | Num | Variable Qualifier | Upper end of reference range for continuous measurements in standardized units. Should be populated only for continuous results. | Perm | |
LBSTNRC | Reference Range for Char Rslt-Std Unit | Char | Variable Qualifier | For normal range values that are character in ordinal scale or if categorical ranges were supplied (e.g., -1 to +1; NEGATIVE TO TRACE). | Perm | |
LBNRIND | Reference Range Indicator | Char | Variable Qualifier | Indicates where value falls with respect to reference range defined by LBORNRLO and LBORNRHI, LBSTRNRLO and LBSTNRHI, or by LBSTNRC. Examples: NORMAL, ABNORMAL, HIGH, LOW. Sponsors should specify in the study metadata (Comments column in the data definition file) whether LBNRIND refers to the original or standard reference ranges and results. Should not be used to indicate biological significance. | Perm | |
LBSTAT | Completion Status | Char | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in LBORRES. | Perm | |
LBREASND | Reason Not Done | Char | Record Qualifier | Describes why LBSTAT is NOT DONE, such as BROKEN EQUIPMENT or SPECIMEN LOST. | Perm | |
LBNAM | Laboratory Name | Char | Record Qualifier | Name or identifier of the laboratory or vendor that provided the test results. | Perm | |
LBSPEC | Specimen Material Type | Char | Record Qualifier | Defines the type of specimen analyzed to obtain the measurement or finding. Examples: WHOLE BLOOD, SERUM, PLASMA, URINE, LIVER, HEART. | Exp | |
LBANTREG | Anatomical Region of Specimen | Char | Variable Qualifier | Defines the specific anatomical or biological region of a tissue, organ specimen, or the region from which the specimen was obtained, such as a section or part of what is defined in the LBSPEC variable. If the anatomical region is not included in the specimen description LBSPEC, it may be included in this variable. This field can be a combination of terms where needed. This field can be null if not applicable. Examples: CORTEX, MEDULLA, MUCOSA, SEROSA, ISLET, ZONA FASICULATA, ZONA RETICULARIS, CRANIAL, MEDIAN, ACCESSORY, SPINAL, LUMBAR, FRONTAL. | Perm | |
LBSPCCND | Specimen Condition | Char | Record Qualifier | Free or standardized text describing the condition of the specimen. Examples: HEMOLYZED, ICTERIC, LIPEMIC | Perm | |
LBSPCUFL | Specimen Usability for the Test | Char | Record Qualifier | Describes the usability of the specimen for the test. Should be N if the specimen is not usable; otherwise it should be null. | Perm | |
LBLOC | Specimen Collection Location | Char | Record Qualifier | Location relevant to the collection of specimen for the measurement. | Perm | |
LBLAT | Specimen Laterality within Subject | Char | Variable Qualifier | Qualifier for laterality of the specimen within the subject for paired specimens. Examples: LEFT, RIGHT, BILATERAL. | Perm |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
LBDIR | Specimen Directionality within Subject | Char | Variable Qualifier | Qualifier for directionality of the specimen within the subject. Examples: DORSAL, PROXIMAL. | Perm | |
LBPORTOT | Portion or Totality | Char | Variable Qualifier | Qualifier for anatomical location or specimen further detailing the portion or totality, which means arrangement of, or apportioning of. Examples: ENTIRE, SINGLE, SEGMENT, MANY. | Perm | |
LBMETHOD | Method of Test or Examination | Char | Record Qualifier | Method of the test or examination. Examples: EIA (Enzyme Immunoassay), ELECTROPHORESIS, DIPSTICK. | Exp | |
LBBLFL | Baseline Flag | Char | Record Qualifier | A baseline indicator may be used to calculate differences or changes from baseline. Value should be Y or null. The baseline flag is sponsor defined. | Exp | |
LBFAST | Fasting Status | Char | Record Qualifier | Indicator used to identify fasting status. The value should be Y or null | Perm | |
LBDRVFL | Derived Flag | Char | Record Qualifier | Used to indicate a derived record. The value should be Y or null. Records that represent the average of other records, or are not as originally received or collected are examples of records that might be derived for the submission datasets. | Perm | |
LBTOX | Toxicity | Char | Variable Qualifier | Description of toxicity quantified by LBTOXGR. The sponsor is expected to provide the name and version of the scale used to map the terms, utilizing the data definition file external codelist attributes. | Perm | |
LBTOXGR | Standard Toxicity Grade | Char | Record Qualifier | Records toxicity grade value using a standard toxicity scale (such as the NCI CTCAE). If value is from a numeric scale, represent only the number (e.g., "2" and not "Grade 2"). The sponsor is expected to provide the name of the scale and version used to map the terms, utilizing the data definition file external codelist attributes. | Perm | |
LBEXCLFL | Exclusion Flag | Char | Record Qualifier | "Y" if the result should be excluded from all calculations, otherwise null. | Perm | |
LBREASEX | Reason for Exclusion | Char | Record Qualifier | The reason the result should be excluded from all calculations. Used only when LBEXCLFL is "Y". | Perm | |
LBUSCHFL | Unscheduled Flag | Char | Record Qualifier | Indicates whether the timing of the specimen collection was unscheduled. If a specimen collection was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are "Y" or null. | Exp | |
VISITDY | Planned Study Day of Collection | Num | Timing | Planned study day of specimen collection. Should be an integer. | Perm | |
LBDTC | Date/Time of Specimen Collection | Char | ISO 8601 | Timing | Date/Time of specimen collection, in IS0 8601 format. | Exp |
LBENDTC | End Date/Time of Specimen Collection | Char | ISO 8601 | Timing | Date/Time of the end of specimen collection in ISO 8601 format. Should be populated only for continuous sample collection. | Perm |
LBDY | Study Day of Specimen Collection | Num | Timing | Study day of specimen collection, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | |
LBENDY | Study Day of End of Specimen Collection | Num | Timing | Study day of the end of specimen collection, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | |
LBNOMDY | Nominal Study Day for Tabulations | Num | Timing | Nominal study day used for grouping records for specimen collections that may occur on different days into a single reported study day. Should be an integer. | Exp | |
LBNOMLBL | Label for Nominal Study Day | Char | Timing | A label for a given value of LBNOMDY as presented in the study report. Examples: Week 4, Day 28, Terminal Sac. | Perm | |
LBTPT | Planned Time Point Name | Char | Timing | Text Description of time when specimen should be taken. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See LBTPTNUM and LBTPTREF. Examples: Start, 5 min post. | Perm |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
LBTPTNUM | Planned Time Point Number | Num | Timing | Numerical version of LBTPT to aid in sorting. | Perm | |
LBELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 | Timing | Elapsed time (in ISO 8601 format) relative to a planned fixed reference (LBTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: "- P15M" to represent the period of 15 minutes prior to the reference point indicated by LBTPTREF, or "P8H" to represent the period of 8 hours after the reference point indicated by LBTPTREF. | Perm |
LBTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by LBELTM, if used for LBTPTNUM, and LBTPT. It is recommended that LBTPTREF be as descriptive as possible so the reference time point can be inferred without looking at other variables. Examples: PREVIOUS DOSE, PREVIOUS MEAL. | Perm | |
LBRFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 | Timing | Date/Time of the reference time point, LBTPTREF | Perm |
Assumptions for Laboratory Test Results (LB) Domain Model
The Laboratory Test Results (LB) domain captures laboratory data collected by the lab executing the study or data received from a central provider.
Results definition:
LBSTRESC (or corresponding numeric LBSTRESN) is used to represent standardized format of original results. For instance, original results such as "NEG" or "NEGATIVE" may be represented in standard format as "NEGATIVE" in LBSTRESC.
LBORNRLO and LBORNRHI represent the reference range in original units, and LBSTNRLO and LBSTNRHI represent the reference range in standard units. These variables are permissible, since many tests may not have well-established ranges or the ranges would not apply.
For lab tests that do not have continuous numeric results (e.g., urine protein as measured by dipstick, descriptive tests such as urine color), LBSTNRC could be populated either with normal character range values in an ordinal scale (e.g., "NEGATIVE to TRACE") or a delimited set of values that are considered to be normal (e.g., "YELLOW", "AMBER").
LBSTAT and LBREASND are permissible and are used to indicate when a test was not completed. In these cases, LBSTAT should contain "NOT DONE"; LBORRES, LBSTRESC, and LBSTRESN should be null. LBREASND should contain the reason for not completing the test.
Specimen collection location - organ/tissue definition:
The location of specimen collection for a subject is described by the following fields: LBSPEC, LBANTREG, and LBLOC.
LBSPEC is Expected and defines the specimen type or the base organ or tissue analyzed.
LBANTREG is permissible and further specifies a part or section of the organ/tissue specified in LBSPEC. Examples include the cortex of the kidney or a study-specific sectioning of the organ (e.g., top section of left liver lobe).
LBLOC is permissible to specify location of specimen collection. If a sample of blood is taken, LBLOC may be used to indicate the location of sampling (e.g., jugular vein, portal vein). Another example could be if the specimen type (LBSPEC) is "BONE MARROW"; LBLOC could be "Femoral" or "Sternal".
Timing variables:
Information about the time of collection for any observation is needed to identify the record. LBDTC is expected, and the data will, in most cases, contain LBDTC, LBDY, or both. However, some studies (e.g., legacy studies) may not collect LBDTC or LBDY; in such cases, LBNOMDY must be populated.
For lab tests where the specimen is collected over time (e.g., 24-hour urine collection), the start date/time of the collection goes into LBDTC and the end date/time of collection goes into LBENDTC.
Pooling:
For lab results that correspond to samples pooled from different subjects, POOLID will be populated with a unique number identifying the pool (see Section 8.5.1, Pool Definition - POOLDEF).
One record will exist for each pool in LB. Populating POOLID will mark the result as being collected at a pool level and not on a subject level.
Other assumptions:
A value derived by a lab according to their procedures is considered as having an origin value of collected, rather than derived.
A single reference range can be included for either standard results (LBSTNRLO and LBSTNRHI) or original results (LBORNRLO and LBORNRHI), but not both. LBNRIND is used as a reference range indicator for the range being used.
Examples for Laboratory Test Results (LB) Domain Model
Example 1
lb.xpt
Row | STUDYID | DOMAIN | USUBJID | LBSEQ | LBTESTCD | LBTEST | LBCAT | LBSCAT | LBORRES | LBORRESU | LBSTRESC | LBSTRESN | LBSTRESU | LBSTNRLO | LBSTNRHI | LBNRIND | LBSTAT | LBREASND | LBSPEC | LBMETHOD | LBBLFL | LBFAST | LBDRVFL | LBUSCHFL | LBDTC | LBDY | LBNOMDY | LBNOMLBL |
1 | ABC | LB | ABC-001- 001 | 1 | ALB | Albumin | CLINICAL CHEMISTRY | LIVER FUNCTION | 30 | kg/m3 | 3.0 | 3 | g/dL | 3.5 | 5 | LOW | SERUM | Y | Y | 2006-07- 19T08:30 | 1 | 1 | Chemistry Day 1 | |||||
2 | ABC | LB | ABC-001- 001 | 2 | ALP | Alkaline Phosphatase | CLINICAL CHEMISTRY | GENERAL | 398 | U/L | 398 | 398 | U/L | 40 | 160 | SERUM | Y | 2006-07- 19T08:30 | 1 | 1 | Chemistry Day 1 | |||||||
3 | ABC | LB | ABC-001- 001 | 3 | ALP | Alkaline Phosphatase | CLINICAL CHEMISTRY | GENERAL | 350 | U/L | 350 | 350 | U/L | 40 | 160 | SERUM | Y | 2006-07- 20T12:30 | 2 | 1 | Chemistry Day 1 | |||||||
4 | ABC | LB | ABC-001- 001 | 4 | ALP | Alkaline Phosphatase | CLINICAL CHEMISTRY | GENERAL | 374 | U/L | 374 | 374 | U/L | 40 | 160 | SERUM | Y | Y | Y | 2006-07- 19T08:30 | 1 | 1 | Chemistry Day 1 | |||||
5 | ABC | LB | ABC-001- 001 | 5 | WBC | Leukocytes | HEMATOLOGY | 5.9 | 10^9/L | 5.9 | 5.9 | 10^9/L | 4 | 11 | WHOLE BLOOD | Y | Y | 2006-07- 19T08:30 | 1 | 1 | Hematology Day 1 | |||||||
6 | ABC | LB | ABC-001- 001 | 6 | LYMLE | Lymphocytes/ Leukocytes | HEMATOLOGY | DIFFERENTIAL | 6.7 | % | 6.7 | 6.7 | % | 25 | 40 | LOW | WHOLE BLOOD | Y | Y | 2006-07- 19T08:30 | 1 | 1 | Hematology Day 1 | |||||
7 | ABC | LB | ABC-001- 001 | 7 | NEUT | Neutrophils | HEMATOLOGY | DIFFERENTIAL | 5.1 | 10^9/L | 5.1 | 5.1 | 10^9/L | 2 | 8 | WHOLE BLOOD | Y | Y | 2006-07- 19T08:30 | 1 | 1 | Hematology Day 1 | ||||||
8 | ABC | LB | ABC-001- 001 | 8 | PH | pH | URINALYSIS | 7.5 | 7.5 | 7.5 | 5.00 | 9.00 | URINE | Y | Y | 2006-07- 19T08:30 | 1 | 1 | Urinalysis Day 1 | |||||||||
9 | ABC | LB | ABC-001- 001 | 9 | ALB | Albumin | CLINICAL CHEMISTRY | LIVER FUNCTION | NOT DONE | Insufficient sample | SERUM | 2006-07- 24T09:00 | 6 | 6 | Chemistry Day 6 |
Row | STUDYID | DOMAIN | USUBJID | LBSEQ | LBTESTCD | LBTEST | LBCAT | LBSCAT | LBORRES | LBORRESU | LBSTRESC | LBSTRESN | LBSTRESU | LBSTNRLO | LBSTNRHI | LBNRIND | LBSTAT | LBREASND | LBSPEC | LBMETHOD | LBBLFL | LBFAST | LBDRVFL | LBUSCHFL | LBDTC | LBDY | LBNOMDY | LBNOMLBL |
10 | ABC | LB | ABC-001- 001 | 10 | CREAT | Creatinine | CLINICAL CHEMISTRY | 0.9 | mg/Dl | 80 | 80 | umol/L | 44.201 | 114.9226 | SERUM | 2006-07- 24T09:00 | 6 | 6 | Chemistry Day 6 | |||||||||
11 | ABC | LB | ABC-001- 001 | 11 | WBC | Leukocytes | HEMATOLOGY | 5.9 | 10^9/L | 5.9 | 5.9 | 10^9/L | 4 | 11 | WHOLE BLOOD | Y | 2006-07- 24T09:00 | 6 | 6 | Hematology Day 6 | ||||||||
12 | ABC | LB | ABC-001- 001 | 12 | CHOL | Cholesterol | CLINICAL CHEMISTRY | 229 | mg/dL | 229 | 229 | mg/dL | 0 | 199 | HIGH | SERUM | 2006-07- 24T09:00 | 6 | 6 | Chemistry Day 6 | ||||||||
13 | ABC | LB | ABC-001- 001 | 13 | WBC | Leukocytes | HEMATOLOGY | 9.8 | 10^9/L | 9.8 | 9.8 | 10^9/L | 4 | 11 | WHOLE BLOOD | Y | 2006-07- 27T06:42 | 9 | 9 | Unscheduled Hematology Day 9 |
supplb.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG | QEVAL |
1 | ABC | LB | ABC-001-001 | LBSEQ | 1 | BIOSIG | Biological Significance | N | OTHER | PRINCIPAL INVESTIGATOR |
2 | ABC | LB | ABC-001-001 | LBSEQ | 6 | BIOSIG | Biological Significance | N | OTHER | PRINCIPAL INVESTIGATOR |
Example 2
lb.xpt
Row | STUDYID | DOMAIN | USUBJID | LBSEQ | LBTESTCD | LBTEST | LBCAT | LBORRES | LBORRESU | LBORNRLO | LBORNRHI | LBSTRESC | LBSTRESN | LBSTRESU | LBSTNRLO | LBSTNRHI | LBSPEC | LBMETHOD | LBBLFL | LBDTC | LBENDTC | LBDY | LBENDY | LBNOMDY | LBTPT | LBTPTNUM | LBELTM | LBTPTREF | LBRFTDTC |
1 | ABC | LB | ABC-001- | 1 | GLUCOSE | Glucose | URINALYSIS | 7 | mg/dL | 1 | 15 | 0.39 | 0.39 | mmol/L | 0.06 | 0.83 | URINE | 2006-07- | 2006-07- | 1 | 1 | 1 | Predose | 1 | -P15M | Day 1 dose | 2006-07- | ||
001 | 19T04:00 | 19T07:45 | 19T08:00 | ||||||||||||||||||||||||||
2 | ABC | LB | ABC-001- | 2 | GLUCOSE | Glucose | URINALYSIS | 11 | mg/dL | 1 | 15 | 0.61 | 0.61 | mmol/L | 0.06 | 0.83 | URINE | 2006-07- | 2006-07- | 1 | 1 | 1 | 0-8 | 2 | P8H | Day 1 dose | 2006-07- | ||
001 | 19T08:00 | 19T16:00 | hours | 19T08:00 | |||||||||||||||||||||||||
after | |||||||||||||||||||||||||||||
dosing | |||||||||||||||||||||||||||||
3 | ABC | LB | ABC-001- | 3 | GLUCOSE | Glucose | URINALYSIS | 9 | mg/dL | 1 | 15 | 0.50 | 0.50 | mmol/L | 0.06 | 0.83 | URINE | 2006-07- | 2006-07- | 1 | 2 | 1 | 8-16 | 3 | P16H | Day 1 dose | 2006-07- | ||
001 | 19T16:00 | 20T00:00 | hours | 19T08:00 | |||||||||||||||||||||||||
after | |||||||||||||||||||||||||||||
dosing | |||||||||||||||||||||||||||||
4 | ABC | LB | ABC-001- | 4 | COLOR | Color | URINALYSIS | YELLOW | YELLOW | URINE | 2006-07- | 2006-07- | 1 | 2 | 1 | 8-16 | 3 | P16H | Day 1 dose | 2006-07- | |||||||||
001 | 19T16:00 | 20T00:00 | hours | 19T08:00 | |||||||||||||||||||||||||
after | |||||||||||||||||||||||||||||
dosing |
Example 3
This is an example of urine glucose test records, 1 with a result and 1 with no result because the test was not performed due to sample being insufficient.
lb.xpt
Row | STUDYID | DOMAIN | USUBJID | LBSEQ | LBTESTCD | LBTEST | LBCAT | LBORRES | LBORRESU | LBSTRESC | LBSTRESN | LBSTRESU | LBSTAT | LBREASND | LBSPEC | LBMETHOD | LBBLFL | LBDTC | LBDY | LBNOMDY |
1 | ABC | LB | ABC-001- 001 | 1 | GLUCOSE | Glucose | URINALYSIS | NEGATIVE | NEGATIVE | URINE | 2006-07- 19T04:00 | 1 | 1 | |||||||
2 | ABC | LB | ABC-001- 002 | 1 | GLUCOSE | Glucose | CLINICAL CHEMISTRY | NOT DONE | SAMPLE EXHAUSTED | SERUM | 2006-07- 24T08:00 | 5 | 5 |
Example 4
This is an example of albumin tests done for pooled subjects. Samples from subjects ABC-009, ABC-010, and ABC-011 were pooled, and their results were reported as pooled results. The associated POOLDEF rows follow, to illustrate the pool definition.
lb.xpt
Row | STUDYID | DOMAIN | USUBJID | POOLID | LBSEQ | LBTESTCD | LBTEST | LBCAT | LBORRES | LBORRESU | LBSTRESC | LBSTRESN | LBSTRESU | LBSPEC | LBMETHOD | LBBLFL | LBDTC | LBDY | LBNOMDY |
1 | ABC | LB | POOL001 | 1 | ALB | Albumin | CLINICAL CHEMISTRY | 3.0 | g/dL | 3.0 | 3.0 | g/dL | SERUM | 2006-07-19T04:00 | 1 | 1 |
pooldef.xpt
Row | STUDYID | POOLID | USUBJID |
1 | ABC | POOL001 | ABC-009 |
2 | ABC | POOL001 | ABC-010 |
3 | ABC | POOL001 | ABC-011 |
Example 5
The following example shows cases of categorical data that cannot be considered as numeric, even though in some cases it appears that the data includes a number. The allowed values in these ranges should be defined in the data definition file. Samples were collected at one point and not over a given interval.
lb.xpt
Row | STUDYID | DOMAIN | USUBJID | LBSEQ | LBTESTCD | LBTEST | LBCAT | LBORRES | LBORRESU | LBSTRESC | LBSTRESN | LBSTRESU | LBSTNRC | LBSPEC | LBMETHOD | LBBLFL | LBDTC | LBDY | LBNOMDY |
1 | ABC | LB | ABC-001-001 | 1 | KETONES | Ketones | URINALYSIS | SMALL | SMALL | NEGATIVE TO LARGE | URINE | 2006-07-19 | 1 | 1 | |||||
2 | ABC | LB | ABC-001-002 | 2 | KETONES | Ketones | URINALYSIS | LARGE | LARGE | NEGATIVE TO LARGE | URINE | 2006-07-19 | 1 | 1 | |||||
3 | ABC | LB | ABC-001-001 | 3 | BILI | Bilirubin | URINALYSIS | NEGATIVE | NEGATIVE | NEGATIVE TO 3+ | URINE | 2006-07-19 | 1 | 1 | |||||
4 | ABC | LB | ABC-001-002 | 4 | BILI | Bilirubin | URINALYSIS | 2+ | 2+ | NEGATIVE TO 3+ | URINE | 2006-07-19 | 1 | 1 | |||||
5 | ABC | LB | ABC-001-001 | 5 | PROT | Protein | URINALYSIS | TRACE | TRACE | NEGATIVE TO 100 | URINE | 2006-07-19 | 1 | 1 | |||||
6 | ABC | LB | ABC-001-002 | 6 | PROT | Protein | URINALYSIS | 30 | 30 | NEGATIVE TO 100 | URINE | 2006-07-19 | 1 | 1 |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
DOMAIN | Domain Abbreviation | Char | MA | Identifier | Two-character code for the domain. | Req |
USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | |
FOCID | Focus of Study- Specific Interest | Char | Identifier | Identification of a focus of study-specific interest on or within a subject or specimen as defined in the protocol, for which a measurement, test, or examination was performed. An example could be a drug application site, e.g., "Injection site 1," "Biopsy site 1," "Treated site 1." the value in this variable should have inherent semantic value. | Perm | |
MASEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | |
MAGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. This is not the treatment group number. | Perm | |
MAREFID | Specimen Reference Identifier | Char | Identifier | Internal or external specimen identifier. Example: 1009570101. | Perm | |
MASPID | Mass Identifier | Char | Identifier | Mass identifier such as MASS 1 or MASS A. Used when the mass was discovered during the in-life phase or during pathology and was assigned a mass identifier. The mass identification should be unique within the subject, regardless of mass location. | Perm | |
MATESTCD | Macroscopic Examination Short Name | Char | Topic | Short name of the measurement, test, or examination described in MATEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in MATESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). MATESTCD cannot contain characters other than letters, numbers, or underscores. | Req | |
MATEST | Macroscopic Examination Name | Char | Synonym Qualifier | Long name for MATESTCD. The value in MATEST cannot be longer than 40 characters. Extensible controlled values are Gross Pathological Examination, Clinical Signs Follow-up. | Req | |
MABODSYS | Body System or Organ Class | Char | Record Qualifier | Body system or organ class associated with the specimen examined. | Perm | |
MAORRES | Result or Findings as Collected | Char | Result Qualifier | Text description of the findings as originally received or collected, including the base gross pathological observation and any modifiers, such as severity, origin, classification, size, color, etc. | Exp | |
MASTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains only the base gross pathological observation (e.g., ENLARGED) from MAORRES, without any modifiers. If the examination was completed and there were no findings, the value must be UNREMARKABLE. | Exp | |
MASTAT | Completion Status | Char | Record Qualifier | Used to indicate examination not done or result is missing. Should be null if a result exists in MAORRES. | Perm |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
MAREASND | Reason Not Done | Char | Record Qualifier | Describes why MASTAT is NOT DONE. Example: Tissue not examined, Tissue Autolyzed. | Perm | |
MANAM | Laboratory Name | Char | Record Qualifier | Name or identifier of the laboratory or vendor that provided the test results. | Perm | |
MASPEC | Specimen Material Type | Char | Record Qualifier | Defines the type of tissue, organ, or fluid examined. Examples: GLAND, ADRENAL; KIDNEY; VESSEL, LYMPHATIC. See also Assumption 4.b. | Exp | |
MAANTREG | Anatomical Region of Specimen | Char | Variable Qualifier | Defines the specific anatomical or biological region of a tissue, organ specimen, or the region from which the specimen was obtained, such as a section or part of what is defined in the MASPEC variable. If the anatomical region is not included in the specimen description MASPEC, it may be included in this variable. This field can be a combination of terms where needed. This field can be null if not applicable. Examples: CORTEX, MEDULLA, MUCOSA, SEROSA, ISLET, ZONA FASICULATA, ZONA RETICULARIS, CRANIAL, MEDIAN, ACCESSORY, SPINAL, LUMBAR, FRONTAL. | Perm | |
MASPCCND | Specimen Condition | Char | Record Qualifier | Free or standardized text describing the condition of the specimen. Example: AUTOLYZED. | Perm | |
MASPCUFL | Specimen Usability for the Test | Char | Record Qualifier | Describes the usability of the specimen for the test. Should be "N" if the specimen is not usable; otherwise it should be null. | Perm | |
MALAT | Specimen Laterality within Subject | Char | Variable Qualifier | Qualifier for laterality of the specimen within the subject for paired specimens. Examples: LEFT, RIGHT, BILATERAL. | Perm | |
MADIR | Specimen Directionality within Subject | Char | Variable Qualifier | Qualifier for directionality of the specimen within the subject. Examples: DORSAL, PROXIMAL. | Perm | |
MAPORTOT | Portion or Totality | Char | Variable Qualifier | Qualifier for anatomical location or specimen further detailing the portion or totality, which means arrangement of, or apportioning of. Examples: ENTIRE, SINGLE, SEGMENT, MANY. | Perm | |
MAEVAL | Evaluator | Char | Record Qualifier | Role of the person who provided the evaluation. Used only for results that are subjective (i.e., assigned by a person or a group). Examples: PRINCIPAL PATHOLOGIST, PEER REVIEW, SPONSOR PATHOLOGIST. | Perm | |
MASEV | Severity | Char | Record Qualifier | Describes the severity or intensity of a particular finding. Examples: MILD, MODERATE, SEVERE. | Perm | |
MADTHREL | Relationship to Death | Char | Record Qualifier | Describes the relationship of a particular finding to the death of a subject ("Y" = caused death, "N" = did not cause death, "U" = unknown). May be left null if not available. | Perm | |
MADTC | Date/Time | Char | ISO 8601 | Timing | For a specimen collected or observed post mortem, this is the date/time of subject disposition in ISO 8601 format. | Perm |
MADY | Study Day | Num | Timing | For a specimen collected or observed post mortem, this is the study day of subject disposition, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm |
Assumptions for Macroscopic Findings (MA) Domain Model
Definition:
The Macroscopic Findings (MA) dataset provides a record for each macroscopic finding observed.
Every subject examined at necropsy should have at least 1 record in the MA domain (e.g., the record could be NORMAL (in MAORRES) for MASPEC value of "ALL TISSUES", implying all protocol- required tissues).
MATESTCD and MATEST are either GROSPATH and gross pathological examination or CLSFUP and clinical signs follow-up.
In most cases, MATESTCD and MATEST will be GROSPATH and gross pathological examination.
As part of the necropsy review, a follow-up examination may be performed on clinical signs to verify existence at necropsy (present/not present) and to correlate them to gross pathological examinations. To record these in the MA domain, the result should be represented as the text result of the examination (e.g., "SKIN LESION NOT FOUND AT NECROPSY").
The date/time of the subject disposition (in DS) is the most relevant date for interpretation of macroscopic observations and is used to populate MADTC.
Organ/tissue definition:
The subject organ/tissue of examination is described by up to 5 fields: MASPEC, MAANTREG, MALAT, MADIR, and MAPORTOT.
MASPEC defines the base organ or tissue examined and is required when MATEST is "Gross Pathological Examination." It should not be used when MATEST is "Clinical Signs Follow-up". The value is singular in cases of multilateral organs when the MALAT or MADIR fields can be used to describe laterality and/or position.
MAANTREG should be used where applicable, and further specifies a part or section of the organ/tissue specified in MASPEC. Examples include the cortex of the kidney or a study-specific sectioning of the organ (e.g., top section of left liver lobe).
Specify laterality and/or position for those organs that can exist in multiple locations: Use "SINGLE" for MAPORTOT for cases where 1 of the multilateral organs is examined, but which one was used is unknown. Use "BILATERAL" for MALAT for cases where the finding was recorded on the paired organs of a bilateral pair.
For bilateral organs, records may be included for the left, right, and/or both left and right organs.
Result definition:
When the results of all tissues are normal, the special value of "ALL TISSUES" may be used in MASPEC, with a single record whose value in MAORRES is NORMAL and in MASTRESC is UNREMARKABLE, without individually listing each tissue.
MASTRESC: This variable is important for standardizing the value in MAORRES.
Modifiers of the base gross pathological observation (in MASTRESC) should be included within supplemental qualifiers (see SUPPMA Example 1):
QNAM = "--RESMOD"
QLABEL = "Result Modifiers"
QVAL = concatenated modifiers of the base gross pathological process, separated by semicolons
If a severity was received or collected, MASEV must be populated.
MASPID variable is intended to reflect the mass identification. This variable should be used to link in-life findings with pathology findings. The mass identifier in --SPID should be consistent across domains (Clinical Observations, Palpable Masses, MA, Microscopic Findings, and Tumor Findings).
Macroscopic findings commonly correlate to clinical findings and microscopic findings. Establishing this relationship may be accomplished by using the RELREC table (see Section 8.2, Relating Records - RELREC).
Examples for Macroscopic Findings (MA) Domain Model
Example 1
This example demonstrates additional example findings.
ma.xpt
Row | STUDYID | DOMAIN | USUBJID | MASEQ | MASPID | MATESTCD | MATEST | MAORRES | MASTRESC | MASTAT | MAREASND | MASPEC | MAANTREG | MALAT | MADIR | MASEV | MADTC | MADY |
1 | 123456 | MA | 123456- 1001 | 1 | GROSPATH | Gross Pathological Examination | Discoloration dark, mucosa | Discoloration | LARGE INTESTINE, CECUM | 2011-03- 23 | 365 | |||||||
2 | 123456 | MA | 123456- 1001 | 2 | GROSPATH | Gross Pathological Examination | Foci dark, mucosa | Foci | LARGE INTESTINE, COLON | DISTAL | 2011-03- 23 | 365 | ||||||
3 | 123456 | MA | 123456- 1001 | 3 | GROSPATH | Gross Pathological Examination | Congestion, left lobe moderate | Congestion | LUNG | MODERATE | 2011-03- 23 | 365 | ||||||
4 | 123456 | MA | 123456- 1001 | 4 | GROSPATH | Gross Pathological Examination | Bulla, right caudal lobe, 1 cm in diameter, one section | Bulla | LUNG | 2011-03- 23 | 365 | |||||||
5 | 123456 | MA | 123456- 1001 | 5 | GROSPATH | Gross Pathological Examination | Small | Small | THYMUS | 2011-03- 23 | 365 | |||||||
6 | 123456 | MA | 123456- 1002 | 6 | MASS 1 | GROSPATH | Gross Pathological Examination | Mass, approximately 8 mm long, 6 mm wide, 4 mm thick, pale firm well defined | Mass | BONE, FEMUR | STIFLE | LEFT | MEDIAL | 2011-03- 23 | 365 | |||
7 | 123456 | MA | 123456- 1002 | 7 | GROSPATH | Gross Pathological Examination | NOT DONE | Tissue lost | GLAND, PITUITARY | 2011-03- 23 | 365 | |||||||
8 | 123456 | MA | 123456- 1003 | 8 | GROSPATH | Gross Pathological Examination | No necropsy observations noted. | UNREMARKABLE | ALL TISSUES | 2011-03- 23 | 365 | |||||||
9 | 123456 | MA | 123456- 1004 | 9 | GROSPATH | Gross Pathological Examination | Normal | UNREMARKABLE | LARGE INTESTINE, CECUM | 2011-03- 24 | 366 | |||||||
10 | 123456 | MA | 123456- 1004 | 10 | GROSPATH | Gross Pathological Examination | Adhesion | Adhesion | LUNG | 2011-03- 24 | 366 |
suppma.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
1 | 123456 | MA | 123456-1001 | MASEQ | 1 | MARESMOD | Result Modifiers | dark; mucosa | COLLECTED |
2 | 123456 | MA | 123456-1001 | MASEQ | 2 | MARESMOD | Result Modifiers | dark; mucosa | COLLECTED |
3 | 123456 | MA | 123456-1001 | MASEQ | 3 | MARESMOD | Result Modifiers | left lobe | COLLECTED |
4 | 123456 | MA | 123456-1001 | MASEQ | 4 | MARESMOD | Result Modifiers | right caudal lobe; 1 cm in diameter | COLLECTED |
5 | 123456 | MA | 123456-1001 | MASEQ | 6 | MARESMOD | Result Modifiers | approximately 8 mm long, 6 mm wide, 4 mm thick; pale; firm; well defined | COLLECTED |
This table demonstrates the representation of the comment which was included in MAORRES.
co.xpt
Row | STUDYID | DOMAIN | RDOMAIN | USUBJID | COSEQ | IDVAR | IDVARVAL | COVAL | CODTC | CODY |
1 | 123456 | CO | MA | 123456-1001 | 1 | MASEQ | 4 | one section | 2011-03-23 | 365 |
Example 2
This example demonstrates the use of the domain to record clinical signs follow-up examinations performed at necropsy.
Row | STUDYID | DOMAIN | USUBJID | MASEQ | MATESTCD | MATEST | MAORRES | MASTRESC | MASPEC | MAANTREG | MADTC | MADY |
1 | 999123 | MA | 999123- 101 | 16 | CLSFUP | Clinical Signs Follow-up | MASS NOT FOUND AT NECROPSY | MASS NOT FOUND AT NECROPSY | 2000-01- 31T14:33:21 | 365 | ||
2 | 999123 | MA | 999123- 101 | 17 | CLSFUP | Clinical Signs Follow-up | NOT PRESENT | NOT PRESENT | 2000-01- 31T14:33:21 | 365 | ||
3 | 999123 | MA | 999123- 101 | 18 | CLSFUP | Clinical Signs Follow-up | PRESENT | PRESENT | 2000-01- 31T14:33:21 | 365 |
This RELREC demonstrates a linking between a specific clinical observation (CLSEQ) and its corresponding clinical sign follow-up at necropsy (MASEQ).
relrec.xpt
Row | STUDYID | RDOMAIN | USUBJID | POOLID | IDVAR | IDVARVAL | RELTYPE | RELID |
1 | 999123 | CL | 123456 | CLSEQ | 47 | 62 | ||
2 | 999123 | CL | 123456 | CLSEQ | 49 | 63 | ||
3 | 999123 | CL | 123456 | CLSEQ | 51 | 64 | ||
4 | 999123 | MA | 123456 | MASEQ | 16 | 62 | ||
5 | 999123 | MA | 123456 | MASEQ | 17 | 63 | ||
6 | 999123 | MA | 123456 | MASEQ | 18 | 64 |
This example demonstrates a linking between findings across the CL, PM, MA, MI, and TF domains using RELREC. The mass was first identified as an abrasion over several weeks (grouped by CLGRPID = 5), graduating to a mass with several associated clinical findings (identified by a CLSPID of "MASS 2"). These clinical findings correspond to a set of findings in the PM domain, a clinical signs follow-up and gross pathological examination in the MA domain, a
single microscopic finding from the MI domain, and a single tumor finding in the TF domain. Each of the findings in the PM, MA, MI, and TF are related by way of the --SPID field, with a value of "MASS 2".
Because all of these records are related, they are given the same RELID (in this case a value of 80).
relrec.xpt
Row | STUDYID | RDOMAIN | USUBJID | POOLID | IDVAR | IDVARVAL | RELTYPE | RELID |
1 | PY001002 | CL | AA-12540 | CLGRPID | 5 | 80 | ||
2 | PY001002 | CL | AA-12540 | CLSPID | MASS 2 | 80 | ||
3 | PY001002 | PM | AA-12540 | PMSPID | MASS 2 | 80 | ||
4 | PY001002 | MA | AA-12540 | MASPID | MASS 2 | 80 | ||
5 | PY001002 | MI | AA-12540 | MISPID | MASS 2 | 80 | ||
6 | PY001002 | TF | AA-12540 | TFSPID | MASS 2 | 80 |
Example 3
These are example records of a macroscopic evaluation of injection sites (as indicated in FOCID).
ma.xpt
Row | STUDYID | DOMAIN | USUBJID | FOCID | MASEQ | MASPID | MASTESTCD | MATEST | MAORRES | MASTRESC | MASPEC | MAANTREG | MALAT | MADIR | MASEV |
1 | 12345 | MA | 12345001 | Injection site 1 | 1 | GROSPATH | Gross Pathological Examination | Fur thin cover | Focal hair loss | SKIN | LEFT | DORSOCRANIAL | |||
2 | 12345 | MA | 12345001 | Injection site 2 | 2 | GROSPATH | Gross Pathological Examination | Unremarkable | UNREMARKABLE | SKIN | RIGHT | DORSOCRANIAL | |||
3 | 12345 | MA | 12345001 | Injection site 3 | 3 | GROSPATH | Gross Pathological Examination | Focal hemorrhage | Hemorrhage | SKIN | LEFT | DORSOCAUDAL | |||
4 | 12345 | MA | 12345001 | Injection site 4 | 4 | MASS 1 | GROSPATH | Gross Pathological Examination | Mass, approximately 8 mm long, 4 mm thick, pale firm well defined | Mass | SKIN | RIGHT | DORSOCAUDAL | ||
5 | 12345 | MA | 12345002 | Injection site 1 | 1 | GROSPATH | Gross Pathological Examination | Unremarkable | UNREMARKABLE | SKIN | LEFT | DORSOCRANIAL | |||
6 | 12345 | MA | 12345002 | Injection site 2 | 2 | GROSPATH | Gross Pathological Examination | Discoloration; subcutaneous; red; slight | Discoloration | SKIN | RIGHT | DORSOCRANIAL | MILD | ||
7 | 12345 | MA | 12345002 | Injection site 3 | 3 | GROSPATH | Gross Pathological Examination | Unremarkable | UNREMARKABLE | SKIN | LEFT | DORSOCAUDAL | |||
8 | 12345 | MA | 12345002 | Injection site 4 | 4 | GROSPATH | Gross Pathological Examination | Mucosal hemorrhage (about 2x2 cm), moderate | Hemorrhage | SKIN | RIGHT | DORSOCAUDAL | MODERATE |
Note that the concept of "MASS 1" (in CLSPID) is different from "Injection site 1" (in FOCID), in that information in the FOCID variable is known prior to the examination, but the mass ID/sponsor identifier is assigned as part of the examination. FOCID thereby qualifies the test, whereas CLSPID qualifies the result.
cl.xpt
Row | STUDYID | DOMAIN | USUBJID | FOCID | CLSEQ | CLSPID | CLTESTCD | CLTEST | CLCAT | CLORRES | CLSTRESC | CLLOC | CLSEV | CLDTC | CLDY | CLNOMDY |
1 | 12345 | CL | 12345001 | Injection site 1 | 1 | SKINEX | Skin Examination | CLINICAL SIGNS | Fur, Thin Cover; Left Scapula | Fur, Thin Cover | Left Scapula | 2004-07- 19 | 42 | 42 | ||
2 | 12345 | CL | 12345001 | Injection site 2 | 2 | SKINEX | Skin Examination | CLINICAL SIGNS | No Abnormal Findings, Right Scapula | Unremarkable | Right Scapula | 2004-07- 19 | 42 | 42 | ||
3 | 12345 | CL | 12345001 | Injection site 3 | 3 | SKINEX | Skin Examination | CLINICAL SIGNS | No Abnormal Findings, Left Medial Back | Unremarkable | Left Medial Back | 2004-07- 19 | 42 | 42 | ||
4 | 12345 | CL | 12345001 | Injection site 4 | 4 | MASS 1 | SKINEX | Skin Examination | CLINICAL SIGNS | Moderate Swelling, Right Medial Back | Swelling | Right Medial Back | MODERATE | 2004-07- 19 | 42 | 42 |
5 | 12345 | CL | 12345002 | Injection site 1 | 1 | SKINEX | Skin Examination | CLINICAL SIGNS | No Abnormal Findings, Left Scapula | Unremarkable | Left Scapula | 2004-07- 19 | 42 | 42 | ||
6 | 12345 | CL | 12345002 | Injection site 2 | 2 | SKINEX | Skin Examination | CLINICAL SIGNS | Slight Reddening, Right Scapula | Reddening | Right Scapula | MILD | 2004-07- 19 | 42 | 42 | |
7 | 12345 | CL | 12345002 | Injection site 3 | 3 | SKINEX | Skin Examination | CLINICAL SIGNS | Abrasion, Left Medial Back | Abrasion | Left Medial Back | 2004-07- 19 | 42 | 42 | ||
8 | 12345 | CL | 12345002 | Injection site 4 | 4 | SKINEX | Skin Examination | CLINICAL SIGNS | Moderate Reddening, Right Medial Back | Reddening | Right Medial Back | MODERATE | 2004-07- 19 | 42 | 42 |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
DOMAIN | Domain Abbreviation | Char | MI | Identifier | Two-character abbreviation for the domain. | Req |
USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | |
FOCID | Focus of Study- Specific Interest | Char | Identifier | Identification of a focus of study-specific interest on or within a subject or specimen as defined in the protocol for which a measurement, test, or examination was performed. An example could be a drug application site, e.g., "Injection site 1," "Biopsy site 1," "Treated site 1." the value in this variable should have inherent semantic value. | Perm | |
MISEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | |
MIGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. This is not the treatment group number. | Perm | |
MIREFID | Specimen Reference Identifier | Char | Identifier | Internal or external specimen identifier. Example: Specimen barcode number. | Perm | |
MISPID | Mass Identifier | Char | Identifier | Mass identifier such as MASS 1 or MASS A. Used when the mass was discovered during the in-life phase or during pathology and was assigned a mass identifier. The mass identification should be unique within the subject, regardless of mass location. | Perm |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
MITESTCD | Microscopic Examination Short Name | Char | Topic | Short name of the measurement, test, or examination described in MITEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in MITESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). MITESTCD cannot contain characters other than letters, numbers, or underscores. Extensible controlled value is MIEXAM covering an assessment by microscope (e.g., light, elctron, confocal, etc). | Req | |
MITEST | Microscopic Examination Name | Char | Synonym Qualifier | Long name for MITESTCD. The value in MITEST cannot be longer than 40 characters. Extensible controlled value is Microscopic Examination. | Req | |
MIBODSYS | Body System or Organ Class | Char | Record Qualifier | Body system or organ class associated with the specimen examined. | Perm | |
MIORRES | Result or Findings as Collected | Char | Result Qualifier | Microscopic finding as originally recorded, including all modifiers. | Exp | |
MISTRESC | Standardized Result in Character Format | Char | Result Qualifier | For non-neoplastic findings, contains only the base pathological process (e.g., NECROSIS) without any modifiers such as severity, distribution, chronicity or characteristics. If the examination was completed and there were no findings, the value must be UNREMARKABLE. The base pathological process from MIORRES should be mapped to a synonymous term from the controlled list, NONNEO, where possible. Neoplastic findings must be populated using the NEOPLASM controlled list. | Exp | |
MIRESCAT | Result Category | Char | Variable Qualifier | Used to categorize the result of a finding. Example: MALIGNANT for tumor findings or NON- NEOPLASTIC for pathology findings. | Perm | |
MICHRON | Chronicity of Finding | Char | Variable Qualifier | Describes the apparent relative duration of a particular finding. Examples: ACUTE, CHRONIC. | Exp | |
MIDISTR | Distribution Pattern of Finding | Char | Variable Qualifier | Distribution pattern of a particular finding(s) within the examined area. Examples: DIFFUSE, FOCAL, MULTIFOCAL. | Exp | |
MISTAT | Completion Status | Char | Record Qualifier | Used to indicate a test was not done or a test was attempted but did not generate a result. Should be null or have a value of NOT DONE. | Perm | |
MIREASND | Reason Not Done | Char | Record Qualifier | Describes why MISTAT is NOT DONE, such as SAMPLE AUTOLYZED or SPECIMEN LOST. | Perm | |
MINAM | Laboratory Name | Char | Record Qualifier | Name or identifier of the laboratory or vendor that provided the test results. | Perm | |
MISPEC | Specimen Material Type | Char | Record Qualifier | Defines the type of tissue, orgain, or fluid specimen examined. Examples: LIVER, HEART, BONE MARROW. | Req | |
MIANTREG | Anatomical Region of Specimen | Char | Variable Qualifier | The protocol-defined subregion of the specimen examined. Example: Cortex or Medulla (if the MISPEC is, for example, GLAND, ADRENAL). | Perm | |
MISPCCND | Specimen Condition | Char | Record Qualifier | Free or standardized text describing the condition of the specimen. Example: AUTOLYZED. | Exp | |
MISPCUFL | Specimen Usability for the Test | Char | Record Qualifier | Describes the usability of the specimen for the test. Should be "N" if the specimen is not usable; otherwise it should be null. | Exp |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
MILAT | Specimen Laterality within Subject | Char | Variable Qualifier | Qualifier for laterality of the specimen within the subject for paired specimens. Examples: LEFT, RIGHT, BILATERAL. | Perm | |
MIDIR | Specimen Directionality within Subject | Char | Variable Qualifier | Qualifier for directionality of the specimen within the subject. Examples: DORSAL, PROXIMAL. | Perm | |
MIMETHOD | Method of Test or Examination | Char | Record Qualifier | Method of the test or examination. This could be different types of staining used for the slides whenever appropriate. Example: H&E. | Perm | |
MIEVAL | Evaluator | Char | Record Qualifier | Role of the person who provided the evaluation. Examples: TOX PATHOLOGIST, PEER REVIEW, SPONSOR PATHOLOGIST. | Perm | |
MISEV | Severity | Char | Record Qualifier | Describes the severity of a particular finding. | Exp | |
MIDTHREL | Relationship to Death | Char | Record Qualifier | Describes the relationship of a particular finding to the death of a subject ("Y" = caused death, "N" = did not cause death, "U" = unknown). May be left null if not available. | Perm | |
MIDTC | Date/Time | Char | ISO 8601 | Timing | For a specimen collected or observed post mortem, this is the date/time of subject disposition, in ISO 8601 format. | Perm |
MIDY | Study Day | Num | Timing | For a specimen collected or observed post mortem, this is the study day of subject disposition, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm |
Assumptions for Microscopic Findings (MI) Domain Model
Definition:
The Microscopic Findings (MI) domain captures the microscopic evaluations/histopathology of the study.
This domain should contain at least 1 record for every protocol-scheduled tissue for all subjects in the study (e.g., if an organ was examined and no pathological changes were present, it should have a record indicating "UNREMARKABLE"). Unscheduled tissues that were examined should also have a record. Subjects that were not scheduled for examination should not have records unless they were examined. This assumption supports the creation of incidence tables and statistical analysis on histopathological data.
The MI dataset provides a record for each microscopic finding observed throughout the study.
The date/time of the subject disposition in DS is the most relevant date for interpretation of microscopic observations and is used to populate MIDTC.
Specimen definition:
The protocol-scheduled organ/tissue for examination is described by up to 5 fields: MISPEC, MIANTREG, MILAT, MIDIR, and FOCID.
MISPEC defines the base organ or tissue examined.
MIANTREG should be used where applicable and further specifies a part or section of the organ/tissue specified in MISPEC, when that subregion is the targeted area for examination. Examples include the cortex of the kidney, when separated from the kidney medulla, or a study-specific sectioning of the organ (e.g., top section of left liver lobe), but not a case where the liver is examined as a whole, but a specific finding is found for one of the lobes.
For a paired organ, the organ used for the specimen should be specified as left, right, or bilateral, using the MILAT variable.
Result definition:
In MIORRES, a finding should comprise only 1 base pathological process and its modifiers (e.g., severity, chronicity, distribution, characteristics). However, it is recognized that data may not have been captured in this way; Example 2 shows a way to handle this situation.
When MIORRES is populated, there must be an entry in MISTRESC. Other relevant components of the MIORRES finding must be parsed into 1 or more of these variables: MISEV, MIDISTR, MICHRON, and the supplemental qualifier MIRESMOD, which are used in combination to standardize the value in MIORRES.
MISTRESC: This variable is important for standardizing the value in MIORRES and where possible must use the controlled lists NONNEO and NEOPLASM. If a microscopic finding in a tissue includes 2 related processes, then it can be described by a combination term that has both terms entered, separated by a "/" with no spaces. For example, features of degeneration and regeneration may be observed in a tissue as a continuum of the pathology. The processes can be identified separately or as part of a combined process of degeneration/regeneration. When the process of degeneration/regeneration is used to describe both components, this base process should be recorded in MISTRESC in a single row. The most common combination terms have been included on the NONNEO codelist. Other combination terms that represent 2 related processes can be constructed using preferred terms on the NONNEO codelist, separated by a "/" with no spaces. Terms should not be combined for processes that are unrelated (e.g., NECROSIS and CYST). Unrelated processes should be presented in 2 separate rows.
The variables MISTRESC, MIDISTR, and MICHRON use CDISC Controlled Terminology derived from INHAND (International Harmonization of Nomenclature and Diagnostic Criteria for Lesions in Rats and Mice), a collaboration among international societies of toxicological pathologists.
The supplemental qualifier MIRESMOD is used to further qualify the finding recorded in MISTRESC. MIRESMOD must be populated if 1 or more modifiers were part of the result in MIORRES and not otherwise reported in the modifier variables part of the MI domain structure (e.g., MISEV, MIDISTR, and MICHRON). In addition to describing observed characteristics of a lesion (e.g., cell type), this variable may be used to identify a specific region affected by the finding within the specimen. For example, when the liver is examined as a whole, but a finding is noted for a specific lobe, this location goes into MIRESMOD. Note that MIANTREG qualifies the excised specimen, whereas MIRESMOD qualifies the particular base pathological process identified within that excised specimen. In general, values for MIRESMOD should be separated by a semicolon unless they only make sense together. An example of an anatomic term is "bile duct"; this cannot be split into "bile" and "duct." An example of a term that should be separated is "centrilobular hepatocytic," which contains 2 terms that stand independently ("centrilobular" and "hepatocytic"). See the SUPPMI examples for further guidance on the use of MIRESMOD.
QNAM (Variable Name) | QLABEL (Variable Label) | QVAL (Controlled Terms, Codelist, or Format) | Variable Definition |
MIRESMOD | Result Modifiers | See Assumption 4.c | Key adjective(s) that further describe(s) or qualify a particular base pathologic process contained in MISTRESC.Key adjectives include a specific region affected by the base pathological process (e.g., Stomach – forestomach, cardia, fundus, pylorus), the specific cell type or tissue affected (e.g., neutrophilic, granulomatous, hepatocellular), tinctorial changes, types of pigments (e.g., hemosiderin), cell locations (e.g., extracellular, intracellular), inclusions (e.g., macrovesicular, microvesicular) and infectious agents (e.g., bacterial, fungal). Modifiers captured in other variables (e.g. |
QNAM (Variable Name) | QLABEL (Variable Label) | QVAL (Controlled Terms, Codelist, or Format) | Variable Definition |
SEV, DISTR, CHRON) should not be repeated in this variable. |
The use of MIRESMOD does not preclude sponsors from creating other supplemental qualifiers containing specifically defined modifiers. It is currently expected that MIRESMOD will contain the complete list of modifiers not contained in standard variables (e.g., MISEV, MIDISTR, MICHRON) regardless of their being part of sponsor-defined supplemental qualifiers.
Tumor findings should have a record in this domain, even if they also have records in the TF domain. It is, however, not required to populate MIRESCAT for tumor findings in the MI domain.
When MIORRES contains a tumor finding the corresponding term from NEOPLASM (CDISC Controlled Terminology list) should be used to populate MISTRESC.
For TF domain: When MISTRESC contains a tumor finding, the corresponding term from the NEOPLASM CT list should be used to populate TFSTRESC. Additional variables populated in the MI domain (e.g., MICHRON, MIDISTR, MIRESMOD) are not populated in the TF domain, since they are not needed to create the tumor.xpt file (see Appendix C, Mapping To tumor.xpt File).
Expectations of when MISTAT is "NOT DONE":
If an organ (scheduled for histopathology or introduced later because of adverse findings) for some reason was not examined, the record will have a blank value in MIORRES and MISTAT will be "NOT DONE". NOTE: Failure to adhere to this assumption will preclude generation of the tumor.xpt dataset.
ii. Use of MISTAT and MIREASND: Whenever MISTAT is "NOT DONE", MIREASND should provide the reason for not completing the evaluation as described in the study plan.
i. For microscopic evaluations that have numeric results (e.g., specific cell count tests), MISTRESN and MISTRESU should be included, as well as other applicable variables for the Findings observation class to reflect the data accurately.
The MISPID variable is intended to reflect the mass identification. This variable should be used to link in- life findings (e.g., mass identification) with pathology findings. The mass identifier in --SPID should be consistent across domains (Clinical Observations, Palpable Masses, Macroscopic Findings, MI, and TF).
The value in FOCID should have semantic value; that is, although "1" is not considered adequate, "Injection site 1" is acceptable.
Examples for Microscopic Findings (MI) Domain Model
Example 1
This example shows different types of histopathological findings for 3 different animals.
Therefore, the list of tissues comprising the specimen becomes the SPEC value for each contributing tissue, noted by a slash, as is found in the controlled terminology list.
The MIDTHREL is "N" because the tumor is incidental.
mi.xpt
Row | STUDYID | DOMAIN | USUBJID | MISEQ | MIGRPID | MISPID | MISTESTCD | MITEST | MIORRES | MISTRESC | MICHRON | MIDISTR | MIRESCAT | MISTAT | MIREASND | MISPEC | MIANTREG | MISPCCND | MISPCUFL | MILAT | MIDIR | MISEV | MIDTHREL | MIDTC | MIDY |
1 | 123 | MI | 123-01 | 1 | MIEXAM | Microscopic Examination | Amyloidosis, grade 2 | AMYLOID | NON- NEOPLASTIC | TESTIS/EPIDIDYMIS | MILD | 2015- 10-27 | 365 | ||||||||||||
2 | 123 | MI | 123-01 | 2 | MIEXAM | Microscopic Examination | Inflammation, acute, grade 2 | INFLAMMATION | ACUTE | NON- NEOPLASTIC | TESTIS/EPIDIDYMIS | MILD | 2015- 10-27 | 365 | |||||||||||
3 | 123 | MI | 123-01 | 3 | MIEXAM | Microscopic Examination | Degeneration/regeneration, myofiber, grade 4 | DEGENERATION/ REGENERATION | NON- NEOPLASTIC | MUSCLE, SKELETAL | MARKED | 2015- 10-27 | 365 | ||||||||||||
4 | 123 | MI | 123-01 | 4 | MIEXAM | Microscopic Examination | NOT DONE | Tissue not present for histologic examination no glandular tissue in section | GLAND, MAMMARY | 2015- 10-27 | 365 | ||||||||||||||
5 | 123 | MI | 123-01 | 5 | MIEXAM | Microscopic Examination | Normal | UNREMARKABLE | GLAND, PARATHYROID | 2015- 10-27 | 365 | ||||||||||||||
6 | 123 | MI | 123-02 | 6 | MIEXAM | Microscopic Examination | Inflammation, meninges, grade 5 | INFLAMMATION | NON- NEOPLASTIC | BRAIN | SEVERE | Y | 2015- 05-15 | 200 | |||||||||||
7 | 123 | MI | 123-03 | 7 | MIEXAM | Microscopic Examination | Hyperplasia, endometrial cystic, grade 3 | HYPERPLASIA | NON- NEOPLASTIC | UTERUS | MODERATE | 2015- 10-27 | 365 | ||||||||||||
8 | 123 | MI | 123-03 | 8 | MASS 1 | MIEXAM | Microscopic Examination | Adenoma: tubulostromal (benign neoplasm), left | ADENOMA, TUBULOSTROMAL, BENIGN | BENIGN | OVARY | LEFT | N | 2015- 10-27 | 365 | ||||||||||
9 | 123 | MI | 123-03 | 9 | 1 | MASS 2 | MIEXAM | Microscopic Examination | Sarcoma: endometrial stromal (malignant neoplasm), Primary | STROMAL SARCOMA, ENDOMETRIAL, MALIGNANT | MALIGNANT | UTERUS | N | 2015- 10-27 | 365 | ||||||||||
10 | 123 | MI | 123-03 | 10 | 2 | MIEXAM | Microscopic Examination | Lymphoma: metastasis | LYMPHOMA, MALIGNANT | METASTATIC | UTERUS | U | 2015- 10-27 | 365 | |||||||||||
11 | 123 | MI | 123-03 | 11 | 1 | MASS 3 | MIEXAM | Microscopic Examination | Sarcoma: metastasis; Uterus was the primary site | SARCOMA, MALIGNANT | METASTATIC | VAGINA | N | 2015- 10-27 | 365 | ||||||||||
12 | 123 | MI | 123-03 | 12 | 2 | MIEXAM | Microscopic Examination | Lymphoma: metastasis | LYMPHOMA, MALIGNANT | METASTATIC | VAGINA | U | 2015- 10-27 | 365 | |||||||||||
13 | 123 | MI | 123-03 | 13 | 2 | MIEXAM | Microscopic Examination | Lymphoma: multicentric | LYMPHOMA, MALIGNANT | MALIGNANT | SITE, UNCERTAIN PRIMARY | Y | 2015- 10-27 | 365 | |||||||||||
14 | 123 | MI | 123-04 | 14 | MIEXAM | Microscopic Examination | Infiltrate, mononuclear cell, grade 1 | INFILTRATE | NON- NEOPLASTIC | MENINGES | MINIMAL | 2015- 10-27 | 365 | ||||||||||||
15 | 123 | MI | 123-04 | 15 | MIEXAM | Microscopic Examination | Atrophy, multifocal, grade 2 | ATROPHY | MULTIFOCAL | NON- NEOPLASTIC | TESTIS | MILD | 2015- 10-27 | 365 | |||||||||||
16 | 123 | MI | 123-04 | 16 | MIEXAM | Microscopic Examination | Intra-alveolar hemorrhage, right, grade 2 | HEMORRHAGE | NON- NEOPLASTIC | LUNG | CRANIAL LOBE | RIGHT | MILD | 2015- 10-27 | 365 | ||||||||||
17 | 123 | MI | 123-04 | 17 | MIEXAM | Microscopic Examination | Cyst, right, anterior | CYST | NON- NEOPLASTIC | KIDNEY | RIGHT | ANTERIOR | 2015- 10-27 | 365 | |||||||||||
18 | 123 | MI | 123-05 | 18 | MIEXAM | Microscopic Examination | Inflammation, moderate, chronic, multifocal, mucosal, forestomach, grade 3 | INFLAMMATION | CHRONIC | MULTIFOCAL | NON- NEOPLASTIC | STOMACH | MODERATE | 2015- 10-27 | 365 | ||||||||||
19 | 123 | MI | 123-06 | 19 | MIEXAM | Microscopic Examination | Hepatocellular carcinoma (malignant neoplasm without metastasis), incidental | CARCINOMA, HEPATOCELLULAR, MALIGNANT | MALIGNANT | LIVER | N | 2015- 10-07 | 345 |
suppmi.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG | QEVAL |
1 | 123 | MI | 123-01 | MISEQ | 3 | MIRESMOD | Result Modifiers | Myofiber | COLLECTED | PATHOLOGIST |
2 | 123 | MI | 123-03 | MISEQ | 7 | MIRESMOD | Result Modifiers | Endometrial; Cystic | COLLECTED | PATHOLOGIST |
3 | 123 | MI | 123-03 | MISEQ | 9 | MIRESMOD | Result Modifiers | Primary | COLLECTED | PATHOLOGIST |
4 | 123 | MI | 123-03 | MISEQ | 13 | MIRESMOD | Result Modifiers | Multicentric | COLLECTED | PATHOLOGIST |
5 | 123 | MI | 123-04 | MISEQ | 14 | MIRESMOD | Result Modifiers | Mononuclear Cell | COLLECTED | PATHOLOGIST |
6 | 123 | MI | 123-04 | MISEQ | 16 | MIRESMOD | Result Modifiers | Intraalveolar | COLLECTED | PATHOLOGIST |
7 | 123 | MI | 123-05 | MISEQ | 18 | MIRESMOD | Result Modifiers | Mucosal; Forestomach | COLLECTED | PATHOLOGIST |
This comment table shows the representation of the comment that was included in MIORRES.
co.xpt
Row | STUDYID | DOMAIN | RDOMAIN | USUBJID | COSEQ | IDVAR | IDVARVAL | COVAL | CODTC |
1 | 123 | CO | MI | 123-03 | 1 | MISEQ | 11 | Site of primary neoplasm: UTERUS | |
2 | 123 | CO | MI | 123-01 | 2 | MISPEC | GLAND, PARATHYROID | One of pair present |
Example 2
This example shows some multiple-base pathological processes, collected as if they were one finding.
The original descriptive text by the pathologist is repeated in the original result fields (MIORRES), because a finding should comprise only 1 base pathological process and its modifiers (severity, chronicity, or distribution, and the remaining in result modifiers as a supplemental qualifier record). Because there are 3 base processes described in MIORRES, there needs to be 3 records, each with 1 base process in MISTRESC.
mi.xpt
Row | STUDYID | DOMAIN | USUBJID | MISEQ | MIGRPID | MIREFID | MITESTCD | MITEST | MIORRES | MISTRESC | MICHRON | MIDISTR | MISPEC | MISPCCND | MISPCUFL | MISEV | MIDTC | MIDY |
1 | ABC | MI | ABC-101 | 1 | 1 | 101-A1 | MIEXAM | Microscopic Examination | Necrosis-hepatocytes in centrilobular area surrounded by slight acute inflammation with moderate hemorrhage | NECROSIS | LIVER | 1991-05- 17 | 91 | |||||
2 | ABC | MI | ABC-101 | 2 | 1 | 101-A1 | MIEXAM | Microscopic Examination | Necrosis-hepatocytes in centrilobular area surrounded by slight acute inflammation with moderate hemorrhage | INFLAMMATION | ACUTE | LIVER | MILD | 1991-05- 17 | 91 | |||
3 | ABC | MI | ABC-101 | 3 | 1 | 101-A1 | MIEXAM | Microscopic Examination | Necrosis-hepatocytes in centrilobular area surrounded by slight acute inflammation with moderate hemorrhage | HEMORRHAGE | LIVER | MODERATE | 1991-05- 17 | 91 |
This row shows the supplemental qualifier record for the modifiers associated with the findings in row 1.
suppmi.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG | QEVAL |
1 | ABC | MI | ABC-101 | MISEQ | 3 | MIRESMOD | Result Modifiers | Hepatocytes; Centrilobular | COLLECTED | PATHOLOGIST |
Example 3
This example shows the result of a histopathological evaluation of 2 injection sites on 1 animal.
mi.xpt
Row | STUDYID | DOMAIN | USUBJID | FOCID | MISEQ | MITESTCD | MITEST | MIORRES | MISTRESC | MICHRON | MIDISTR | MISPEC | MISPCCND | MISPCUFL | MISEV | MIDTC | MIDY |
1 | ABC | MI | ABC-101 | Injection Site 1 | 1 | MIEXAM | Microscopic Examination | Subcutaneous Inflammation, Minimal | INFLAMMATION | SITE, INJECTION | MINIMAL | 2015-10- 27 | 42 | ||||
2 | ABC | MI | ABC-101 | Injection Site 1 | 2 | MIEXAM | Microscopic Examination | Panniculus Muscle- Inflammation/Degeneration, Focal, Slight | INFLAMMATION/ DEGENERATION | FOCAL | SITE, INJECTION | MILD | 2015-10- 27 | 42 | |||
3 | ABC | MI | ABC-101 | Injection Site 2 | 3 | MIEXAM | Microscopic Examination | Subcutaneous Hemorrhage, Minimal | HEMORRHAGE | SITE, INJECTION | MINIMAL | 2015-10- 27 | 42 |
This row shows the supplemental qualifier record for the modifiers associated with the findings in MI.
suppmi.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG | QEVAL |
1 | ABC | MI | ABC-101 | MISEQ | 1 | MIRESMOD | Result Modifiers | Subcutaneous | COLLECTED | PATHOLOGIST |
2 | ABC | MI | ABC-101 | MISEQ | 2 | MIRESMOD | Result Modifiers | Panniculus Muscle | COLLECTED | PATHOLOGIST |
3 | ABC | MI | ABC-101 | MISEQ | 3 | MIRESMOD | Result Modifiers | Subcutaneous | COLLECTED | PATHOLOGIST |
Example 4
This example shows how to tabulate data for a bilateral organ, where both sides were examined and only 1 result was reported.
One side was unremarkable and the other side had a finding. "UNREMARKABLE" was not tabulated; only the finding was included. Per schedule, both sides of the kidney were examined, so MILAT is "BOTH". Because the finding is reported for 1 unspecified side (unilateral), this is the result location, consequently tabulated as a result modifier (see MIRESMOD example below).
mi.xpt
Row | STUDYID | DOMAIN | USUBJID | MISEQ | MITESTCD | MITEST | MIORRES | MISTRESC | MICHRON | MIDISTR | MISPEC | MISPCCND | MISPCUFL | MILAT | MISEV | MIDTC | MIDY |
1 | ABC | MI | ABC-101 | 1 | MIEXAM | Microscopic Examination | Acute focal glomerular hemorrhage, unilateral | HEMORRHAGE | ACUTE | FOCAL | KIDNEY | BOTH | 2015-10-27 | 42 |
This row shows the supplemental qualifier record for the modifiers associated with the findings in MI.
suppmi.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG | QEVAL |
1 | ABC | MI | ABC-101 | MISEQ | 1 | MIRESMOD | Result Modifiers | glomerular; unilateral | COLLECTED | PATHOLOGIST |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
DOMAIN | Domain Abbreviation | Char | OM | Identifier | Two-character abbreviation for the domain. | Req |
USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | |
OMSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | |
OMTESTCD | Test Short Name | Char | Topic | Short name of the measurement, test, or examination described in OMTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in OMTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). OMTESTCD cannot contain characters other than letters, numbers, or underscores. | Req | |
OMTEST | Test Name | Char | Synonym Qualifier | Long name for OMTESTCD. The value in OMTEST cannot be longer than 40 characters. | Req | |
OMORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp | |
OMORRESU | Unit of the Original Result | Char | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology (http://www.cdisc.org/terminology) list. | Exp | |
OMSTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from OMORRES in a standard format or in standard units. OMSTRESC should store all results or findings in character format; if results are numeric, they should also be submitted in numeric format in OMSTRESN. | Exp | |
OMSTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of OMSTRESC. OMSTRESN should store all numeric test results or findings. | Exp | |
OMSTRESU | Unit of the Standardized Result | Char | Variable Qualifier | Standardized unit used for OMSTRESC and OMSTRESN. | Exp | |
OMSTAT | Completion Status | Char | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in OMORRES. | Perm | |
OMREASND | Reason Not Done | Char | Record Qualifier | Describes why OMSTAT is NOT DONE, such as BROKEN EQUIPMENT or TECHNICIAN OVERSIGHT. | Perm | |
OMSPEC | Specimen Material Type | Char | Record Qualifier | Defines the type of tissue, organ, or fluid specimen used as the object for the finding. Examples: GLAND, ADRENAL, KIDNEY, VESSEL, LYMPHATIC. | Req | |
OMANTREG | Anatomical Region of Specimen | Char | Variable Qualifier | Defines the specific anatomical or biological region of a tissue, organ specimen, or the region from which the specimen was obtained, such as a section or part of what is defined in the OMSPEC variable. If the anatomical region is not included in the specimen description OMSPEC, it may be included in this variable. This field can be a combination of terms where needed. This field can be blank if not applicable. Examples: CORTEX, MEDULLA, MUCOSA, SEROSA, ISLET, ZONA | Perm |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
FASICULATA, ZONA RETICULARIS, CRANIAL, MEDIAN, ACCESSORY, SPINAL, LUMBAR, FRONTAL. | ||||||
OMSPCCND | Specimen Condition | Char | Record Qualifier | Free or standardized text describing the condition of the specimen. Example: FIXED. | Perm | |
OMSPCUFL | Specimen Usability for the Test | Char | Record Qualifier | Describes the usability of the specimen for the test. Should be "N" if the specimen is not usable; otherwise it should be null. | Perm | |
OMLAT | Specimen Laterality within Subject | Char | Variable Qualifier | Qualifier for laterality of the specimen within the subject for paired specimens. Examples: LEFT, RIGHT, BILATERAL. | Perm | |
OMDIR | Specimen Directionality within Subject | Char | Variable Qualifier | Qualifier for directionality of the specimen within the subject. Examples: DORSAL, PROXIMAL. | Perm | |
OMPORTOT | Portion or Totality | Char | Variable Qualifier | Qualifier for anatomical location or specimen further detailing the portion or totality, which means arrangement of, or apportioning of. Examples: ENTIRE, SINGLE, SEGMENT, MANY. | Perm | |
OMEXCLFL | Exclusion Flag | Char | Record Qualifier | "Y" if the result should be excluded from all calculations, otherwise null. | Perm | |
OMREASEX | Reason for Exclusion | Char | Record Qualifier | The reason the result should be excluded from all calculations. Used only when OMEXCLFL is "Y". | Perm | |
OMDTC | Date/Time Organ Measured | Char | ISO 8601 | Timing | Date/Time of specimen/tissue weighing, in ISO 8601 format. | Exp |
OMDY | Study Day of Measurement | Num | Timing | Study day of specimen/tissue weighing, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | |
OMNOMDY | Nominal Study Day for Tabulations | Num | Timing | Nominal study day: Used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer. | Exp | |
OMNOMLBL | Label for Nominal Study Day | Char | Timing | A label for a given value of OMNOMDY as presented in the study report (examples: "Week 4," "Day 28," "Terminal Sac"). | Perm |
Assumptions for Organ Measurements (OM) Domain Model
The Organ Measurements (OM) domain contains details of organ measurements and relative organ weights.
Terminal body weight will be recorded in the BW domain.
Organ measurement ratios within a single test or measurement should either be pure ratios with the unit shown as "RATIO" or percentages with the unit shown as "%."
Currently in this model, the sponsor is not expected to attempt to relate the organ weight ratios to their underlying source results used in the calculation through the RELREC or GRPID mechanisms.
Examples for Organ Measurements (OM) Domain Model
Example 1
The following example shows how a sponsor would supply a domain containing organ weights and relative organ weights.
om.xpt
Row | STUDYID | DOMAIN | USUBJID | OMSEQ | OMTESTCD | OMTEST | OMORRES | OMORRESU | OMSTRESC | OMSTRESN | OMSTRESU | OMSTAT | OMREASND | OMSPEC | OMDTC | OMDY |
1 | MOCK | OM | SUB1 | 1 | WEIGHT | Weight | 10.0 | g | 10.0 | 10.0 | g | LIVER | 2006-10- 08 | 5 | ||
2 | MOCK | OM | SUB2 | 2 | WEIGHT | Weight | 9.8 | g | 9.8 | 9.8 | g | LIVER | 2006-10- 08 | 5 | ||
3 | MOCK | OM | SUB3 | 3 | WEIGHT | Weight | 10.3 | g | 10.3 | 10.3 | g | LIVER | 2006-10- 08 | 5 | ||
4 | MOCK | OM | SUB1 | 4 | WEIGHT | Weight | 11.0 | g | 11.0 | 11.0 | g | BRAIN | 2006-10- 08 | 5 | ||
5 | MOCK | OM | SUB2 | 5 | WEIGHT | Weight | 10.2 | g | 10.2 | 10.2 | g | BRAIN | 2006-10- 08 | 5 | ||
6 | MOCK | OM | SUB3 | 6 | WEIGHT | Weight | 10.3 | g | 10.3 | 10.3 | g | BRAIN | 2006-10- 08 | 5 | ||
7 | MOCK | OM | SUB1 | 7 | WEIGHT | Weight | 10.0 | g | 10.0 | 10.0 | g | HEART | 2006-10- 08 | 5 | ||
8 | MOCK | OM | SUB2 | 8 | WEIGHT | Weight | 9.8 | g | 9.8 | 9.8 | g | HEART | 2006-10- 08 | 5 | ||
9 | MOCK | OM | SUB3 | 9 | WEIGHT | Weight | 10.3 | g | 10.3 | 10.3 | g | HEART | 2006-10- 08 | 5 | ||
10 | MOCK | OM | SUB1 | 10 | OWBW | Organ to Body Weight Ratio | NOT DONE | MISSING TERMINAL BODY WEIGHT | LIVER | |||||||
11 | MOCK | OM | SUB2 | 11 | OWBW | Organ to Body Weight Ratio | 0.030 | RATIO | 0.030 | 0.03 | RATIO | LIVER | 2006-10- 08 | 5 | ||
12 | MOCK | OM | SUB3 | 12 | OWBW | Organ to Body Weight Ratio | 0.033 | RATIO | 0.033 | 0.033 | RATIO | LIVER | 2006-10- 08 | 5 | ||
13 | MOCK | OM | SUB1 | 16 | OWBR | Organ to Brain Weight Ratio | 0.909 | RATIO | 0.909 | 0.909 | RATIO | LIVER | 2006-10- 08 | 5 | ||
14 | MOCK | OM | SUB2 | 17 | OWBR | Organ to Brain Weight Ratio | 0.961 | RATIO | 0.961 | 0.961 | RATIO | LIVER | 2006-10- 08 | 5 | ||
15 | MOCK | OM | SUB3 | 18 | OWBR | Organ to Brain Weight Ratio | 1.000 | RATIO | 1.000 | 1 | RATIO | OMSTAT | LIVER | 2006-10- 08 | 5 | |
16 | MOCK | OM | SUB1 | 13 | OWHT | Organ to Heart Weight Ratio | 1.000 | RATIO | 1.000 | 1 | RATIO | LIVER | 2006-10- 08 | 5 | ||
17 | MOCK | OM | SUB2 | 14 | OWHT | Organ to Heart Weight Ratio | 1.000 | RATIO | 1.000 | 1 | RATIO | LIVER | 2006-10- 08 | 5 | ||
18 | MOCK | OM | SUB3 | 15 | OWHT | Organ to Heart Weight Ratio | 1.000 | RATIO | 1.000 | 1 | RATIO | LIVER | 2006-10- 08 | 5 |
Example 2: Using Anatomical Regions
om.xpt
Row | STUDYID | DOMAIN | USUBJID | OMSEQ | OMTESTCD | OMTEST | OMORRES | OMORRESU | OMSTRESC | OMSTRESN | OMSTRESU | OMSPEC | OMANTREG | OMLAT | OMDTC | OMDY |
1 | MOCK | OM | SUB1 | 1 | WEIGHT | Weight | 5.0 | g | 5.0 | 5.0 | g | KIDNEY | Cortex | LEFT | 2006-10-08 | 5 |
2 | MOCK | OM | SUB2 | 2 | WEIGHT | Weight | 4.3 | g | 4.3 | 4.3 | g | KIDNEY | Cortex | LEFT | 2006-10-08 | 5 |
3 | MOCK | OM | SUB3 | 3 | WEIGHT | Weight | 5.2 | g | 5.2 | 5.2 | g | KIDNEY | Cortex | LEFT | 2006-10-08 | 5 |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
DOMAIN | Domain Abbreviation | Char | PM | Identifier | Two-character abbreviation for the domain. | Req |
USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | |
PMSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | |
PMGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. This is not the treatment group number. | Perm | |
PMSPID | Mass Identifier | Char | Identifier | Mass identifier such as MASS 1 or MASS A. Used when the mass was discovered during the in- life phase or during pathology and was assigned a mass identifier. The mass identification should be unique within the subject, regardless of mass location. | Exp | |
PMTESTCD | Test Short Name | Char | Topic | Short name of the measurement, test, or examination described in PMTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in PMTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). PMTESTCD cannot contain characters other than letters, numbers, or underscores. | Req | |
PMTEST | Test Name | Char | Synonym Qualifier | Long name for PMTESTCD. The value in PMTEST cannot be longer than 40 characters. | Req | |
PMORRES | Result or Findings as Collected | Char | Variable Qualifier | Text description of findings as originally received or collected. If the examination was not performed, then the value should be null, and NOT DONE should appear in PMSTAT. | Exp | |
PMORRESU | Unit of the Original Result | Char | Variable Qualifier | Units for PMORRES, if available (e.g., for length, width, or depth findings). The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology list. | Exp | |
PMSTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the result value for all findings, copied, or derived from PMORRES in a standard format or standard units. PMSTRESC should store all results or findings (without location of finding) in character format; if results are numeric, they should also be submitted in numeric format in PMSTRESN. | Exp | |
PMSTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of PMSTRESC. PMSTRESN should store all numeric test results or findings. | Exp |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
PMSTRESU | Unit of the Standardized Result | Char | Variable Qualifier | Standardized unit used for PMSTRESC and PMSTRESN. | Exp | |
PMSTAT | Completion Status | Char | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in PMORRES. | Perm | |
PMREASND | Reason Not Done | Char | Record Qualifier | Describes why PMSTAT is NOT DONE, such as MEASUREMENT IMPOSSIBLE DUE TO EXCESSIVE ULCERATION OF MASS. | Perm | |
PMLOC | Location of a Finding | Char | Record Qualifier | Specifies the location of the palpable mass finding. Example: LEFT SHOULDER. | Exp | |
PMEVAL | Evaluator | Char | Record Qualifier | Role of the person who provided the evaluation. Example: TECHNICIAN. | Perm | |
PMUSCHFL | Unscheduled Flag | Char | Record Qualifier | Indicates whether the timing of a performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are "Y" or null. | Perm | |
VISITDY | Planned Study Day of Collection | Num | Timing | Planned study day of collection. Should be an integer. | Perm | |
PMDTC | Date/Time of Observation | Char | ISO 8601 | Timing | Date/Time of the observation in ISO 8601 format. | Exp |
PMDY | Study Day of Observation | Num | Timing | Study day of the observation, measured as integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | |
PMNOMDY | Nominal Study Day for Tabulations | Num | Timing | Nominal study day used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer. | Exp | |
PMNOMLBL | Label for Nominal Study Day | Char | Timing | A label for a given value of PMNOMDY as presented in the study report. Examples: "Week 4," "Day 28," "Terminal Sac". | Perm |
Assumptions for Palpable Masses (PM) Domain Model
The Palpable Masses (PM) domain captures information regarding any palpable masses examined during the experimental phase in the study.
Results definition:
PMORRES should reflect the original result as collected. The data should be reported the way it was collected. Example: A lab may choose to collect all their information on a mass in one long text string, in which case the PMTEST should be "Description" and PMORRES would contain the text string. Another lab may collect the data separately, in which case PMTEST would contain the specific measurement done on the mass. In either case, PMTEST always reflects the granularity of how the data were collected.
PMSTRESC should contain the finding without the location specified in PMLOC.
The PMSPID variable is intended to reflect mass identification. This variable should be used to link in-life findings with pathology findings. The mass identifier in --SPID should be consistent across domains (Clinical Observations, PM, Macroscopic Findings, Microscopic Findings, and Tumor Findings).
PMDTC is expected and the dataset should contain either PMDTC or PMDY to identify the timing of the collection of the observation.
Examples for Palpable Masses (PM) Domain Model
Example 1
This example shows palpable masses captured in the collection system with length, width, and ulceration captured.
pm.xpt
Row | STUDYID | DOMAIN | USUBJID | PMSEQ | PMSPID | PMTESTCD | PMTEST | PMORRES | PMORRESU | PMSTRESC | PMSTRESN | PMSTRESU | PMSTAT | PMREASND | PMLOC | PMDTC | PMDY | PMNOMDY |
1 | 13456 | PM | 13456-01 | 23 | MASS 1 | LENGTH | Length | 2.0 | mm | 2.0 | 2 | mm | LEFT HIND LIMB | 2006-10- 07T15:44:42 | 14 | 14 | ||
2 | 13456 | PM | 13456-01 | 24 | MASS 1 | WIDTH | Width | 1.8 | mm | 1.8 | 1.8 | mm | LEFT HIND LIMB | 2006-10- 07T15:44:42 | 14 | 14 | ||
3 | 13456 | PM | 13456-01 | 25 | MASS 1 | ULCER | Ulceration | NON- ULCERATED | NON- ULCERATED | LEFT HIND LIMB | 2006-10- 07T15:44:42 | 14 | 14 | |||||
4 | 13456 | PM | 13456-01 | 110 | MASS 1 | LENGTH | Length | 2.4 | mm | 2.4 | 2.4 | mm | LEFT HIND LIMB | 2006-10- 14T11:53:01 | 21 | 21 | ||
5 | 13456 | PM | 13456-01 | 111 | MASS 1 | WIDTH | Width | 2.2 | mm | 2.2 | 2.2 | mm | LEFT HIND LIMB | 2006-10- 14T11:53:01 | 21 | 21 | ||
6 | 13456 | PM | 13456-01 | 112 | MASS 1 | ULCER | Ulceration | ULCERATED | ULCERATED | LEFT HIND LIMB | 2006-10- 14T11:53:01 | 21 | 21 | |||||
7 | 13456 | PM | 13456-01 | 26 | MASS 2 | LENGTH | Length | 1.7 | mm | 1.7 | 1.7 | mm | RIGHT SHOULDER | 2006-10- 07T15:51:08 | 14 | 14 | ||
8 | 13456 | PM | 13456-01 | 27 | MASS 2 | WIDTH | Width | 1.6 | mm | 1.6 | 1.6 | mm | RIGHT SHOULDER | 2006-10- 07T15:51:08 | 14 | 14 | ||
9 | 13456 | PM | 13456-01 | 28 | MASS 2 | ULCER | Ulceration | NON- ULCERATED | NON- ULCERATED | RIGHT SHOULDER | 2006-10- 07T15:51:08 | 14 | 14 | |||||
10 | 13456 | PM | 13456-02 | 29 | MASS 1 | LENGTH | Length | 4.7 | mm | 4.7 | 4.7 | mm | LEFT AXILLARY REGION | 2006-10- 07T16:02:37 | 14 | 14 | ||
11 | 13456 | PM | 13456-02 | 30 | MASS 1 | WIDTH | Width | 4.3 | mm | 4.3 | 4.3 | mm | LEFT AXILLARY REGION | 2006-10- 07T16:02:37 | 14 | 14 | ||
12 | 13456 | PM | 13456-02 | 31 | MASS 1 | ULCER | Ulceration | ULCERATED | ULCERATED | LEFT AXILLARY REGION | 2006-10- 07T16:02:37 | 14 | 14 | |||||
13 | 13456 | PM | 13456-02 | 113 | MASS 1 | LENGTH | Length | 4.4 | mm | 4.4 | 4.4 | mm | LEFT AXILLARY REGION | 2006-10- 15T08:12:20 | 22 | 22 | ||
14 | 13456 | PM | 13456-02 | 114 | MASS 1 | WIDTH | Width | 4.1 | mm | 4.1 | 4.1 | mm | LEFT AXILLARY REGION | 2006-10- 15T08:12:20 | 22 | 22 |
Row | STUDYID | DOMAIN | USUBJID | PMSEQ | PMSPID | PMTESTCD | PMTEST | PMORRES | PMORRESU | PMSTRESC | PMSTRESN | PMSTRESU | PMSTAT | PMREASND | PMLOC | PMDTC | PMDY | PMNOMDY |
15 | 13456 | PM | 13456-02 | 115 | MASS 1 | ULCER | Ulceration | NON- ULCERATED | NON- ULCERATED | LEFT AXILLARY REGION | 2006-10- 15T08:12:20 | 22 | 22 | |||||
16 | 13456 | PM | 13456-03 | 48 | MASS 1 | LENGTH | Length | 5.5 | mm | 5.5 | 5.5 | mm | LOWER ABDOMEN | 2006-10- 07T10:51:00 | 14 | 14 | ||
17 | 13456 | PM | 13456-03 | 49 | MASS 1 | WIDTH | Width | 1.9 | mm | 1.9 | 1.9 | mm | LOWER ABDOMEN | 2006-10- 07T10:51:00 | 14 | 14 | ||
18 | 13456 | PM | 13456-03 | 50 | MASS 1 | ULCER | Ulceration | ULCERATED | ULCERATED | LOWER ABDOMEN | 2006-10- 07T10:51:00 | 14 | 14 | |||||
19 | 13456 | PM | 13456-03 | 132 | MASS 1 | LENGTH | Length | NOT DONE | Measurement impossible due to excessive ulceration of mass | LOWER ABDOMEN | 2006-10- 14T07:43:59 | 21 | 21 | |||||
20 | 13456 | PM | 13456-03 | 133 | MASS 1 | WIDTH | Width | NOT DONE | Measurement impossible due to excessive ulceration of mass | LOWER ABDOMEN | 2006-10- 14T07:43:59 | 21 | 21 | |||||
21 | 13456 | PM | 13456-03 | 134 | MASS 1 | ULCER | Ulceration | ULCERATED | ULCERATED | LOWER ABDOMEN | 2006-10- 14T07:43:59 | 21 | 21 |
Example 2
This example shows tests where the observations were collected as single descriptions in the collection system.
pm.xpt
Row | STUDYID | DOMAIN | USUBJID | PMSEQ | PMSPID | PMTESTCD | PMTEST | PMORRES | PMORRESU | PMSTRESC | PMSTRESN | PMSTRESU | PMLOC | PMDTC | PMDY | PMNOMDY |
1 | ABC-123 | PM | ABC0013 | 17 | MASS 1 | DESCR | Description | 2.0 mm x 1.1 mm, Ulcerated, Left Thoracic Region | 2.0 mm x 1.1 mm, Ulceration | LEFT THORACIC REGION | 2000-03- 11 | 42 | 42 | |||
2 | ABC-123 | PM | ABC0016 | 19 | MASS 1 | DESCR | Description | 3.5 mm x 3.4 mm, Red, Ulcerated, Dorsal Tail | 3.5 mm x 3.4 mm, Red, Moderate Ulceration | Dorsal TAIL | 2000-03- 12 | 43 | 43 | |||
3 | ABC-123 | PM | ABC0016 | 25 | MASS 2 | DESCR | Description | 1.1 mm x 0.9 mm, Right Hind Limb | 1.1 mm x 0.9 mm | RIGHT HIND LIMB | 2000-03- 14 | 45 | 45 |
Example 3
This example shows masses with additional tests collected.
pm.xpt
Row | STUDYID | DOMAIN | USUBJID | PMSEQ | PMSPID | PMTESTCD | PMTEST | PMORRES | PMORRESU | PMSTRESC | PMSTRESN | PMSTRESU | PMLOC | PMDTC | PMDY | PMNOMDY |
1 | 123456-A | PM | A0001043 | 102 | MASS 3 | SHAPE | Shape | Round | Round | LOWER ABDOMEN | 2001-09- 16T09:59:04 | 42 | 42 | |||
2 | 123456-A | PM | A0001043 | 103 | MASS 3 | DEPTH | Depth | 0.4 | mm | 0.4 | 0.4 | mm | LOWER ABDOMEN | 2001-09- 16T09:59:04 | 42 | 42 |
3 | 123456-A | PM | A0001043 | 104 | MASS 3 | DIAM | Diameter | 4.7 | mm | 4.7 | 4.7 | mm | LOWER ABDOMEN | 2001-09- 16T09:59:04 | 42 | 42 |
4 | 123456-A | PM | A0001043 | 105 | MASS 3 | LENGTH | Length | 1.6 | mm | 1.6 | 1.6 | mm | LOWER ABDOMEN | 2001-09- 16T09:59:04 | 42 | 42 |
5 | 123456-A | PM | A0001043 | 106 | MASS 3 | WIDTH | Width | 1.4 | mm | 1.4 | 1.4 | mm | LOWER ABDOMEN | 2001-09- 16T09:59:04 | 42 | 42 |
6 | 123456-A | PM | A0001043 | 107 | MASS 3 | CONSIST | Consistency | Hard | Hard | LOWER ABDOMEN | 2001-09- 16T09:59:04 | 42 | 42 | |||
7 | 123456-A | PM | A0001043 | 108 | MASS 3 | COLOR | Color | Yellow | Yellow | LOWER ABDOMEN | 2001-09- 16T09:59:04 | 42 | 42 | |||
8 | 123456-A | PM | A0001043 | 109 | MASS 3 | HAIRCOV | Hair Cover | Y | Y | LOWER ABDOMEN | 2001-09- 16T09:59:04 | 42 | 42 | |||
9 | 123456-A | PM | A0001043 | 110 | MASS 3 | ULCER | Ulceration | NON-ULCERATED | NON-ULCERATED | LOWER ABDOMEN | 2001-09- 16T09:59:04 | 42 | 42 | |||
10 | 123456-A | PM | A0001043 | 111 | MASS 3 | DESCR | Description | Scabbed, Red | Scabbed, Red | LOWER ABDOMEN | 2001-09- 16T09:59:04 | 42 | 42 | |||
11 | 123456-A | PM | A0001201 | 256 | MASS 1 | SHAPE | Shape | Oval | Oval | MID TAIL | 2001-09- 23T11:23:51 | 49 | 49 | |||
12 | 123456-A | PM | A0001201 | 257 | MASS 1 | DEPTH | Depth | 1.0 | mm | 1.0 | 1 | mm | MID TAIL | 2001-09- 23T11:23:51 | 49 | 49 |
13 | 123456-A | PM | A0001201 | 258 | MASS 1 | DIAM | Diameter | 6.1 | mm | 6.1 | 6.1 | mm | MID TAIL | 2001-09- 23T11:23:51 | 49 | 49 |
14 | 123456-A | PM | A0001201 | 259 | MASS 1 | LENGTH | Length | 2.1 | mm | 2.1 | 2.1 | mm | MID TAIL | 2001-09- 23T11:23:51 | 49 | 49 |
15 | 123456-A | PM | A0001201 | 260 | MASS 1 | WIDTH | Width | 1.6 | mm | 1.6 | 1.6 | mm | MID TAIL | 2001-09- 23T11:23:51 | 49 | 49 |
16 | 123456-A | PM | A0001201 | 261 | MASS 1 | CONSIST | Consistency | Soft | Soft | MID TAIL | 2001-09- 23T11:23:51 | 49 | 49 | |||
17 | 123456-A | PM | A0001201 | 262 | MASS 1 | COLOR | Color | Brown | Brown | MID TAIL | 2001-09- 23T11:23:51 | 49 | 49 | |||
18 | 123456-A | PM | A0001201 | 263 | MASS 1 | HAIRCOV | Hair Cover | No | N | MID TAIL | 2001-09- 23T11:23:51 | 49 | 49 | |||
19 | 123456-A | PM | A0001201 | 264 | MASS 1 | ULCER | Ulceration | ULCERATED | ULCERATED | MID TAIL | 2001-09- 23T11:23:51 | 49 | 49 | |||
20 | 123456-A | PM | A0001201 | 265 | MASS 1 | DESCR | Description | Scratch marks around base of mass. | Scratch marks around base of mass. | MID TAIL | 2001-09- 23T11:23:51 | 49 | 49 |
Example 4
This example demonstrates a case where masses converge and diverge.
Row | STUDYID | DOMAIN | USUBJID | PMSEQ | PMGRPID | PMSPID | PMTESTCD | PMTEST | PMORRES | PMORRESU | PMSTRESC | PMSTRESN | PMSTRESU | PMLOC | PMDTC | PMDY | PMNOMDY |
1 | 1A412-Z | PM | 00540101 | 23 | 1 | MASS 1 | LENGTH | Length | 2.1 | mm | 2.1 | 2.1 | mm | MID TAIL | 7 | 7 | |
2 | 1A412-Z | PM | 00540101 | 24 | 1 | MASS 1 | WIDTH | Width | 2.1 | mm | 2.1 | 2.1 | mm | MID TAIL | 7 | 7 | |
3 | 1A412-Z | PM | 00540101 | 25 | 1 | MASS 1 | ULCER | Ulceration | NON-ULCERATED | MID TAIL | 7 | 7 | |||||
4 | 1A412-Z | PM | 00540101 | 65 | 1 | MASS 2 | LENGTH | Length | 1.3 | mm | 1.3 | 1.3 | mm | MID TAIL | 7 | 7 | |
5 | 1A412-Z | PM | 00540101 | 66 | 1 | MASS 2 | WIDTH | Width | 0.9 | mm | 0.9 | 0.9 | mm | MID TAIL | 7 | 7 | |
6 | 1A412-Z | PM | 00540101 | 67 | 1 | MASS 2 | ULCER | Ulceration | ULCERATED | MID TAIL | 7 | 7 | |||||
7 | 1A412-Z | PM | 00540101 | 91 | 1 | MASS 3 | LENGTH | Length | 3.3 | mm | 3.3 | 3.3 | mm | MID TAIL | 14 | 14 | |
8 | 1A412-Z | PM | 00540101 | 92 | 1 | MASS 3 | WIDTH | Width | 3.1 | mm | 3.1 | 3.1 | mm | MID TAIL | 14 | 14 | |
9 | 1A412-Z | PM | 00540101 | 93 | 1 | MASS 3 | ULCER | Ulceration | NON-ULCERATED | MID TAIL | 14 | 14 | |||||
10 | 1A412-Z | PM | 00540101 | 155 | 1 | MASS 4 | LENGTH | Length | 1.9 | mm | 1.9 | 1.9 | mm | MID TAIL | 21 | 21 | |
11 | 1A412-Z | PM | 00540101 | 156 | 1 | MASS 4 | WIDTH | Width | 1.8 | mm | 1.8 | 1.8 | mm | MID TAIL | 21 | 21 | |
12 | 1A412-Z | PM | 00540101 | 157 | 1 | MASS 4 | ULCER | Ulceration | NON-ULCERATED | MID TAIL | 21 | 21 | |||||
13 | 1A412-Z | PM | 00540101 | 170 | 1 | MASS 5 | LENGTH | Length | 1.5 | mm | 1.5 | 1.5 | mm | MID TAIL | 21 | 21 | |
14 | 1A412-Z | PM | 00540101 | 171 | 1 | MASS 5 | WIDTH | Width | 1.2 | mm | 1.2 | 1.2 | mm | MID TAIL | 21 | 21 | |
15 | 1A412-Z | PM | 00540101 | 172 | 1 | MASS 5 | ULCER | Ulceration | ULCERATED | MID TAIL | 21 | 21 |
This example demonstrates relating palpable mass findings to other domains, such as in the case of tumor findings.
relrec.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
1 | F012-007 | PM | 001-0329 | PMSPID | MASS 3 | 34 | |
2 | F012-007 | CL | 001-0329 | CLSPID | MASS 3 | 34 | |
3 | F012-007 | MA | 001-0329 | MASPID | MASS 3 | 34 | |
4 | F012-007 | MI | 001-0329 | MISPID | MASS 3 | 34 | |
5 | F012-007 | TF | 001-0329 | TFSPID | MASS 3 | 34 | |
6 | F012-007 | PM | 001-0450 | PMSPID | MASS 2 | 76 | |
7 | F012-007 | CL | 001-0450 | CLGRPID | 44 | 76 | |
8 | F012-007 | MA | 001-0450 | MASPID | MASS 2 | 76 | |
9 | F012-007 | MI | 001-0450 | MISPID | MASS 2 | 76 | |
10 | F012-007 | TF | 001-0450 | TFSPID | MASS 2 | 76 | |
11 | F012-007 | PM | 001-0501 | PMSEQ | 104 | 89 | |
12 | F012-007 | TF | 001-0501 | TFSEQ | 43 | 89 | |
13 | F012-007 | PM | 001-0563 | PMGRPID | 17 | 91 | |
14 | F012-007 | CL | 001-0563 | CLGRPID | 7 | 91 | |
15 | F012-007 | MA | 001-0563 | MASEQ | 26 | 91 | |
16 | F012-007 | MI | 001-0563 | MISEQ | 47 | 91 | |
17 | F012-007 | MI | 001-0563 | MISEQ | 48 | 91 | |
18 | F012-007 | TF | 001-0563 | TFSEQ | 23 | 91 | |
19 | F012-007 | TF | 001-0563 | TFSEQ | 24 | 91 |
Pharmacokinetics Concentrations – PC
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
DOMAIN | Domain Abbreviation | Char | PC | Identifier | Two-character abbreviation for the domain. | Req |
USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Either USUBJID or POOLID must be populated. | Exp | |
POOLID | Pool Identifier | Char | Identifier | Identifier used for pooling subjects to assign a single finding to multiple subjects. If POOLID is entered, POOLDEF records must exist for each subject and the USUBJID must be null. Either USUBJID or POOLID must be populated. | Perm | |
PCSEQ | Sequence Number | Num | Identifier | The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record. | Req | |
PCGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject or pool. This is not the treatment group number. | Perm | |
PCREFID | Sample Identifier | Char | Identifier | Internal or external specimen identifier. Example: 1009570101. | Perm |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
PCSPID | Sponsor-Defined Identifier | Char | Identifier | Sponsor-defined reference identifier. | Perm | |
PCTESTCD | Test Short Name | Char | Topic | Short name of the analyte (or measurement) described in PCTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in PCTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). PCTESTCD cannot contain characters other than letters, numbers, or underscores. | Req | |
PCTEST | Test Name | Char | Synonym Qualifier | Long name for PCTESTCD, such as the name of the analyte (or measurement). The value in PCTEST cannot be longer than 40 characters. | Req | |
PCCAT | Test Category | Char | Grouping Qualifier | Used to define a category of the pharmacokinetic test performed. Examples: ANALYTE, METABOLITE, SPECIMEN PROPERTY. | Perm | |
PCSCAT | Test Subcategory | Char | Grouping Qualifier | A further categorization of a test category. | Perm | |
PCORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp | |
PCORRESU | Unit of the Original Result | Char | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology (http://www.cdisc.org/terminology) list. | Exp | |
PCSTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from PCORRES in a standard format or standard units. PCSTRESC should store all results or findings in character format; if results are numeric, they should also be submitted in numeric format in PCSTRESN. Results beyond limits of quantitation should be represented with the term "BLQ" for results below the limit and "ALQ" for results above the limit. | Exp | |
PCSTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of PCSTRESC. PCSTRESN should store all numeric test results or findings. For results beyond limits of quantitation, this variable should be left null (e.g., if PCSTRESC is "BLQ", PCSTRESN would be null). | Exp | |
PCSTRESU | Unit of the Standardized Result | Char | Variable Qualifier | Standardized unit used for PCSTRESC and PCSTRESN. | Exp | |
PCSTAT | Completion Status | Char | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in PCORRES. | Perm | |
PCREASND | Reason Not Done | Char | Record Qualifier | Describes why PCSTAT is NOT DONE, such as SPECIMEN LOST. | Perm | |
PCNAM | Laboratory Name | Char | Record Qualifier | Name or identifier of the laboratory or vendor providing the test results. | Perm | |
PCSPEC | Specimen Material Type | Char | Record Qualifier | Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, URINE. | Req | |
PCSPCCND | Specimen Condition | Char | Record Qualifier | Free or standardized text describing the condition of the specimen. Examples: HEMOLYZED, ICTERIC, LIPEMIC. | Perm | |
PCSPCUFL | Specimen Usability for the Test | Char | Record Qualifier | Describes the usability of the specimen for the test. Should be "N" if the specimen is not usable; otherwise it should be null. | Perm |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
PCMETHOD | Method of Test or Examination | Char | Record Qualifier | Method of the test or examination. Examples: HPLC/MS, ELISA. This should contain sufficient information and granularity to allow differentiation of various methods that might have been used within a study. | Perm | |
PCBLFL | Baseline Flag | Char | Record Qualifier | A baseline indicator may be used to calculate differences or changes from baseline. Value should be "Y" or null. The baseline flag is sponsor-defined. | Perm | |
PCFAST | Fasting Status | Char | Record Qualifier | Indicator used to identify fasting status. The value should be "Y" or null. | Perm | |
PCDRVFL | Derived Flag | Char | Record Qualifier | Used to indicate a derived record. The value should be "Y" or null. Records that represent the average of other records are examples of records that would be derived for the submission datasets. | Perm | |
PCLLOQ | Lower Limit of Quantitation | Num | Variable Qualifier | Indicates the lower limit of quantitation for an assay. Units should be those used in PCSTRESU. | Exp | |
PCEXCLFL | Exclusion Flag | Char | Record Qualifier | "Y" if the result should be excluded from all calculations, otherwise null. | Perm | |
PCREASEX | Reason for Exclusion | Char | Record Qualifier | The reason the result should be excluded from all calculations. Used only when PCEXCLFL is "Y". | Perm | |
PCUSCHFL | Unscheduled Flag | Char | Record Qualifier | Indicates whether the timing of the specimen collection was unscheduled. If a specimen collection was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are "Y" or null. | Perm | |
VISITDY | Planned Study Day of Collection | Num | Timing | Planned day of collection. Should be an integer. | Perm | |
PCDTC | Date/Time of Specimen Collection | Char | ISO 8601 | Timing | Date/Time of specimen collection, in ISO 8601 format. If there is no end time, this will be the collection time. | Perm |
PCENDTC | End Date/Time of Specimen Collection | Char | ISO 8601 | Timing | End date/time of specimen collection, in ISO 8601 format. If there is no end time, the collection time should be represented in PCDTC, and PCENDTC should be null. | Perm |
PCDY | Study Day of Specimen Collection | Num | Timing | Study day of specimen collection, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics (DM) domain. | Perm | |
PCENDY | Study Day of End of Specimen Collection | Num | Timing | Study day of the end of specimen collection, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in DM domain. | Perm | |
PCNOMDY | Nominal Study Day for Tabulations | Num | Timing | Nominal study day used for grouping records for specimen collections that may occur on different days into a single reported study day. Should be an integer. | Exp | |
PCNOMLBL | Label for Nominal Study Day | Char | Timing | A label for a given value of PCNOMDY as presented in the study report. Examples: "Week 4", "Day 28". | Perm | |
PCTPT | Planned Time Point Name | Char | Timing | Text description of time when specimen should be taken. Note: This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See PCTPTNUM and PCTPTREF. Examples: Start, 5 min post. | Perm |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
PCTPTNUM | Planned Time Point Number | Num | Timing | Numerical version of PCTPT to aid in sorting. | Perm | |
PCELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 | Timing | Planned elapsed time (in ISO 8601 format) relative to a planned fixed reference (PCTPTREF) such as "Day 1, Dose 1". This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: "PT0H" to represent any predose values; "PT8H" to represent the period of 8 hours after the reference point indicated by PCTPTREF. | Exp |
PCTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by PCELTM, if used for PCTPTNUM, and PCTPT. It is recommended that PCTPTREF be as descriptive as possible so the reference time point can be inferred without looking at other variables. Example: "Day 1, Dose 1". | Exp | |
PCRFTDTC | Date/Time of Reference Point | Char | ISO 8601 | Timing | Date/Time of the reference time point, PCTPTREF. | Exp |
PCEVLINT | Evaluation Interval | Char | ISO 8601 | Timing | Planned evaluation interval associated with a PCTEST record in ISO 8601 format. Example: "- P2H" to represent a planned interval of collection of 2 hours prior to the time point described in PCTPT. | Perm |
Assumptions for Pharmacokinetics Concentrations (PC) Domain Model
The Pharmacokinetics Concentrations (PC) domain represents concentration measurements for administered compounds and their metabolites in a sample. The sample may be from an individual or a pool. In addition to concentration measurements, specimen properties (e.g., volume, pH) are handled as separate tests in this dataset.
The intent of the PC domain is to accurately and clearly represent the raw bioanalytical data (e.g., unaltered and non-transformed drug concentration data). Transformations for toxicokinetics (e.g., BQL values treated as zero) can be described in SUPPPC and PCCALCN.
This domain should support creation of time-series graphs and automatic calculation of pharmacokinetic parameters from sets of related plasma concentrations.
The timing variables needed for toxicokinetic analysis are:
PCNOMDY
PCTPTREF
PCELTM
The combination of NOMDY and --TPTREF, when properly constructed, allows grouping within each time series of the PC records with their respective Pharmacokinetics Parameters (PP) records. In order to achieve this, ensure that the combination of PPNOMDY and PPTPTREF is equivalent to the combination of PCNOMDY and PCTPTREF.
Similar to other domains, NOMDY in the PC domain should be used as a grouping variable. For example, if animal subjects are dosed on day 90 and have a scheduled 48-hour time point collection, PCDY is “92”; NOMDY is “90”, as the reported TK profile is of day 90.
Because --TPTREF must identify a unique dose, it is recommended that ‑‑TPTREF include both the NOMDY and the time point description in order (e.g., “Day 1, Dose 1” and “Day 1, Dose 2” for twice-daily dosing); ambiguous references such as “Most recent dose” should be avoided.
PCELTM must be populated with the nominal time from the reference (dose) in order to accurately construct a graph. Because PCELTM should be the timing used to calculate the profile, PCELTM should not be null for plasma concentrations used to calculate a profile. See Section 4.4.7.2.2, Planned Time Points Relative To a Fixed Reference Point, for further explanation about populating ISO 8601- conformant durations.
When a pre-dose sample is collected as part of the profile analysis, then PCELTM must be populated as "PT0H" because negative elapsed time would lead to an incorrect area under the curve.
In studies with both pre-dose and immediate post-dose sampling, there should not be 2 “PT0H” records for the same profile. The pre-dose sampling should be represented by “PT0H” and the immediate post-dose sampling should be represented by a number slightly higher than zero but lower than the next time point post-dose. PCTPT would then be used to describe these as pre-dose and immediate post-dose, respectively.
If the PCORRES result is outside the limit of quantification,
PCSTRESN should be null and not populated with the value of zero.
When appropriate, populate PCCALCN in the SUPPPC domain with the value used (See Section 4.5.1.1, Original and Standardized Results).
When a measurement is identified as being below a limit of quantification threshold in PCSTRESC, both PCLLOQ and PCSTRESU must be populated; PCLLOQ states the level and PCSTRESU provides the units for PCLLOQ.
Concentration records can be added for unscheduled tests. In this case, the planned fields and those that depend upon the planned fields are left null: PCTPT, PCTPTNUM, PCELTM, PCTPTREF, PCRFTDTC, and PCEVLINT.
Examples for Pharmacokinetics Concentrations (PC) Domain Model
Example 1
This example illustrates a PC record for an unscheduled sample collection. This is for a study with a weekly dosing regimen. The subject was dosed on days 1 and 8, and on day 11 was found to be moribund. PCTPT, PCTPTNUM, and PCELTM were not populated because this was unscheduled.
Note that PCNOMDY was populated with the actual study day for tabulation. PCNOMLBL reflects the label that was used in the study report. PCUSCHFL was populated with "Y" to indicate that this sample collection was unscheduled.
pc.xpt
Row | STUDYID | DOMAIN | USUBJID | PCSEQ | PCTESTCD | PCTEST | PCCAT | PCSCAT | PCORRES | PCORRESU | PCSTRESC | PCSTRESN | PCSTRESU | PCNAM | PCSPEC | PCMETHOD | PCLLOQ | PCUSCHFL | PCDTC | PCDY | PCNOMDY | PCNOMLBL | PCTPT | PCTPTNUM | PCELTM | PCTPTREF | PCRFTDTC |
1 | ABC-123 | PC | ABC-123- 1002 | 1 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 458.07 | ng/mL | 458.07 | 458.07 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | Y | 2017-06- 23T10:49:00 | 11 | 11 | Day 11 Unscheduled | Day 8 Dose | 2017-06- 20T09:49:39 |
Pharmacokinetics Parameters – PP
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
DOMAIN | Domain Abbreviation | Char | PP | Identifier | Two-character abbreviation for the domain. | Req |
USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Either USUBJID or POOLID must be populated. | Exp | |
POOLID | Pool Identifier | Char | Identifier | Identifier used for pooling subjects to assign a single finding to multiple subjects. If POOLID is entered, POOLDEF records must exist for each subject and the USUBJID must be null. Either USUBJID or POOLID must be populated. | Perm | |
PPSEQ | Sequence Number | Num | Identifier | The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record. | Req | |
PPGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject or pool. This is not the treatment group number. | Perm | |
PPTESTCD | Parameter Short Name | Char | Topic | Short name of the measurement, test, or examination described in PPTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in PPTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). PPTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: AUCINT, TMAX, CMAX. | Req | |
PPTEST | Parameter Name | Char | Synonym Qualifier | Long name for PPTESTCD. The value in PPTEST cannot be longer than 40 characters. Examples: AUC from T1 to T2, Time of CMAX, Max Conc. | Req | |
PPCAT | Parameter Category | Char | Grouping Qualifier | Used to define a category of parameters associated with a specific analyte. This must be the analyte in PCTEST whose profile the parameter is associated with. | Exp | |
PPSCAT | Parameter Subcategory | Char | Grouping Qualifier | Categorization of the model type used to calculate the pharmacokinetic parameters. Examples include COMPARTMENTAL, NON-COMPARTMENTAL. | Perm | |
PPORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the measurement or finding as calculated. | Exp | |
PPORRESU | Unit of the Original Result | Char | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the CDISC Controlled Terminology | Exp | |
PPSTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from PPORRES in a standard format or standard units. PPSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in PPSTRESN. For example, if a test has results NONE, NEG, and NEGATIVE in PPORRES and these results effectively have the same meaning, they could be represented in standard format in PPSTRESC as NEGATIVE. For other examples, see general assumptions. | Exp |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
PPSTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of PPSTRESC. PPSTRESN should store all numeric test results or findings. | Exp | |
PPSTRESU | Unit of the Standardized Result | Char | Variable Qualifier | Standardized unit used for PPSTRESC and PPSTRESN. | Exp | |
PPSTAT | Completion Status | Char | Record Qualifier | Used to indicate that a parameter was not calculated. Should be null if a result exists in PPORRES. | Perm | |
PPREASND | Reason Not Done | Char | Record Qualifier | Describes why a parameter was not performed, such as INSUFFICIENT DATA. Used in conjunction with PPSTAT when value is NOT DONE. | Perm | |
PPSPEC | Specimen Material Type | Char | Record Qualifier | Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, URINE. If multiple specimen types are used for a calculation (e.g., serum and urine for creatinine clearance), refer to Section 4.3.6.2 for guidance on how to populate. | Exp | |
VISITDY | Planned Study Day of Collection | Num | Timing | Planned study day of collection. Should be an integer. | Perm | |
PPNOMDY | Nominal Study Day for Tabulations | Num | Timing | Nominal study day used for grouping records for specimen collections that may occur on different days into a single reported study day. Should be an integer. | Exp | |
PPNOMLBL | Label for Nominal Study Day | Char | Timing | A label for a given value of PPNOMDY as presented in the study report. Examples: "Week 4", "Day 28". | Perm | |
PPTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point used as a basis for PPRFTDTC. | Exp | |
PPRFTDTC | Date/Time of Reference Point | Char | ISO 8601 | Timing | Date/Time of the reference time point, PPTPTREF. The values in PPRFTDTC should be the same as that in PCRFTDTC for related records. | Exp |
PPSTINT | Start of Assessment Interval | Char | ISO 8601 | Timing | Start of the assessment interval relative to Time Point Reference (PPTPTREF) in ISO 8601 duration format. Example: When the area under the curve is calculated from 12 to 24 hours (PPTESTCD=AUCT1T2), the value would be PT12H. | Perm |
PPENINT | End of Assessment Interval | Char | ISO 8601 | Timing | End of the assessment interval relative to Time Point Reference (PPTPTREF) in ISO 8601 duration format. Example: When the area under the curve is calculated from 12 to 24 hours (PPTESTCD=AUCT1T2), the value would be PT24H. | Perm |
Assumptions for Pharmacokinetics Parameters (PP) Domain Model
The PP domain represents the pharmacokinetic parameter values for each of the time-concentration profiles.
If a parameter needs to be qualified by an additional parameter, records for both parameters should be included (e.g., AUCLST and TLST).
The combination of --NOMDY and --TPTREF, when properly constructed, allows grouping within each time series of the PC records with their respective PP records.
In studies with serial sampling (i.e., all time points collected from a single animal in order to construct the time-concentration profile), then PCRFTDTC should match PPRFTDTC. Small animal toxicology studies often involve sparse sampling of time points; that is, due to blood volume collection in small animals, sometimes only 2-3 blood collections per day may be possible. In such cases the time- concentration profile may be constructed from 2-3 time points per animal across several animals. In cases of sparse sampling and composite time-concentration curves, it is acceptable to leave PPRFTDTC null. In the event that all subjects in a pool have the same reference time point date, it would also be acceptable to populate PPRFTDTC with the date (no time) that corresponds to the description in TPTREF.
Examples for Pharmacokinetics Parameters (PP) Domain Model
Example 1
This example illustrates several tests for area under the curve, demonstrating the different ways of qualifying these tests. This study had a dosing interval of 24 hours, last dose on day 28, and TK sampling until at least 72 hours.
pp.xpt
Row | STUDYID | DOMAIN | USUBJID | PPSEQ | PPTESTCD | PPTEST | PPCAT | PPSCAT | PPORRES | PPORRESU | PPSTRESC | PPSTRESN | PPSTRESU | PPSTAT | PPREASND | PPSPEC | PPNOMLBL | PPTPTREF | PPRFTDTC | PPSTINT | PPENINT |
1 | ABC-123 | PP | ABC-123- 1001 | 1 | AUCINT | AUC from T1 to T2 | XYZ- 123 | 271 | h*ng/mL | 271 | 271 | h*ng/mL | PLASMA | 1 | Day 1 Dose | 2018-01- 01T09:50:36 | PT0H | PT24H | |||
2 | ABC-123 | PP | ABC-123- 1001 | 2 | AUCLST | AUC to Last Nonzero Conc | XYZ- 123 | 271 | h*ng/mL | 271 | 271 | h*ng/mL | PLASMA | 1 | Day 1 Dose | 2018-01- 01T09:50:36 | |||||
3 | ABC-123 | PP | ABC-123- 1001 | 3 | TLST | Time of Last Nonzero Conc | XYZ- 123 | 24 | h | 24 | 24 | h | PLASMA | 1 | Day 1 Dose | 2018-01- 01T09:50:36 | |||||
4 | ABC-123 | PP | ABC-123- 1001 | 4 | AUCINT | AUC from T1 to T2 | XYZ- 123 | 270 | h*ng/mL | 270 | 270 | h*ng/mL | PLASMA | 28 | Day 28 Dose | 2018-01- 28T09:55:14 | PT0H | PT24H | |||
5 | ABC-123 | PP | ABC-123- 1001 | 5 | AUCINT | AUC from T1 to T2 | XYZ- 123 | 324 | h*ng/mL | 324 | 324 | h*ng/mL | PLASMA | 28 | Day 28 Dose | 2018-01- 28T09:55:14 | PT0H | PT72H | |||
6 | ABC-123 | PP | ABC-123- 1001 | 6 | AUCLST | AUC to Last Nonzero Conc | XYZ- 123 | 324 | h*ng/mL | 324 | 324 | h*ng/mL | PLASMA | 28 | Day 28 Dose | 2018-01- 28T09:55:14 | |||||
7 | ABC-123 | PP | ABC-123- 1001 | 7 | TLST | Time of Last Nonzero Conc | XYZ- 123 | 72 | h | 72 | 72 | h | PLASMA | 28 | Day 28 Dose | 2018-01- 28T09:55:14 |
Relating PP Records to PC Records – RELREC is Optional at this Time for SEND
This section serves as a reference for sponsors wishing to document relationships between pharmacokinetic parameter records in a PP dataset and specific time-point concentration records in a PC dataset according to the SDTM using the RELREC table.
Relating Datasets
If all time-point concentrations in PC are used to calculate all parameters for all subjects, then the relationship between the 2 datasets can be documented as shown in the following table. Note that incorporating the name of the analyte and the day of the collection into the value of --GRPID (or some equivalent method for assigning different values of --GRPID for all the combinations of analytes and reference time points) is necessary when there is more than one reference time point (PCRFTDTC and PPRFTDTC, which are the same for related records) and more than one analyte (PCTESTCD, copied into PPCAT to indicate the analyte with which the parameters are associated), because these variables are part of the natural key for both datasets. In this case, --GRPID is a surrogate key used for the relationship.
relrec.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
1 | ABC-123 | PC | PCGRPID | MANY | A | ||
2 | ABC-123 | PP | PPGRPID | MANY | A |
Relating Records
This section describes 4 possible examples of different types of relationships between PC and PP records for the same drug (drug X). All of these examples use the same PC and PP data. The only variables whose values change across the examples are the sponsor-defined PCGRPID and PPGRPID. As in the case for relating datasets, --GRPID values must take into account all combinations of analytes and reference time points, since both are part of the natural key for both datasets. To conserve space, the PC and PP domains appear only once, but with 4 --GRPID columns, 1 for each of the examples. Note that a submission dataset would contain only a single --GRPID column with a set of values such as those shown in 1 of the 4 columns in the PC and PP datasets, or values defined by the sponsor.
In Example 1, all pharmacokinetic time point-concentration values in the PC dataset are used to calculate all the pharmacokinetic parameters in the PP dataset for days 1 and 8 for 1 subject.
Pharmacokinetic Concentrations (PC) Dataset for All Examples
Pharmacokinetic Parameters (PP) Dataset for All Examples
RELREC Example 1: All PC records used to calculate all pharmacokinetic parameters.
Method A (Many to many, using PCGRPID and PPGRPID)
Method B (One to many, using PCSEQ and PPGRPID)
Method C (Many to one, using PCGRPID and PPSEQ)
Method D (One to one, using PCSEQ and PPSEQ)
In Example 2, 2 PC values were excluded from the calculation of all pharmacokinetic parameters for the day 1 data. Day 8 values are related per Example 1.
RELREC Example 2: Only some records in PC used to calculate all pharmacokinetic parameters.
Method A (Many to many, using PCGRPID and PPGRPID)
Method B (One to many, using PCSEQ and PPGRPID)
Method C (Many to one, using PCGRPID and PPSEQ)
Method D (One to one, using PCSEQ and PPSEQ)
In Example 3, 2 PC values were excluded from the calculation of 2 pharmacokinetic parameters, but used in the others for day 1. Day 8 values are related per Example 1.
RELREC Example 3: Only some records in PC used to calculate some parameters.
Method A (Many to many, using PCGRPID and PPGRPID)
Method B (One to many, using PCSEQ and PPGRPID)
Method C (Many to one, using PCGRPID and PPSEQ)
Method D (One to one, using PCSEQ and PPSEQ)
In Example 4, only some PC records for day 1 were used to calculate parameters: Time point 5 was excluded from Tmax, time point 6 from Cmax, and time points 11 and 12 were excluded from AUC. Day 8 values are related per Example 1.
RELREC Example 4: Only some records in PC used to calculate parameters.
Method A (Many to many, using PCGRPID and PPGRPID)
Method B (One to many omitted; see note below)
Method C (Many to one omitted; see note below)
Method D (One to one, using PCSEQ and PPSEQ)
For each example, PCGRPID and PPGRPID were used to group related records within each respective dataset. The values for these, as well as the values for PCSEQ and PPSEQ, were then used to populate combinations of IDVAR and IDVARVAL in the RELREC table using four methods (A-D) for Examples 1-3.
Note: Only 2 methods (A and D) are shown for Example 4, due to its complexity. Because the relationship between PC records and PP records for day 8 data does not change across the examples, it is shown only for Example 1 and not repeated.
pc.xpt
Row | STUDYID | DOMAIN | USUBJID | PCSEQ | PCGRPID1 | PCGRPID2 | PCGRPID3 | PCGRPID4 | PCREFID | PCTESTCD | PCTEST | PCCAT | PCORRES | PCORRESU | PCSTRESC | PCSTRESN | PCSTRESU | PCSPEC | PCBLFL | PCLLOQ | PCDTC | PCDY | PCNOMDY | PCTPT | PCTPTNUM | PCELTM | PCTPTREF | PCRFTDTC |
1 | ABC-123 | PC | ABC-123- 0001 | 1 | DY1_DRGX | DY1_DRGX | DY1_DRGX_A | DY1_DRGX_A | 123-0001- 01 | DRUG X | STUDYDRUG | ANALYTE | 9 | ug/mL | 9 | 9 | ug/mL | PLASMA | 1.00 | 2001-02- 01T08:35 | 1 | 1 | 5 min | 1 | PT5M | Day 1 Dose | 2001-02- 01T08:30 | |
2 | ABC-123 | PC | ABC-123- 0001 | 2 | DY1_DRGX | DY1_DRGX | DY1_DRGX_A | DY1_DRGX_A | 123-0001- 02 | DRUG X | STUDYDRUG | ANALYTE | 20 | ug/mL | 20 | 20 | ug/mL | PLASMA | 1.00 | 2001-02- 01T08:55 | 1 | 1 | 25 min | 2 | PT25M | Day 1 Dose | 2001-02- 01T08:30 | |
3 | ABC-123 | PC | ABC-123- 0001 | 3 | DY1_DRGX | DY1_DRGX | DY1_DRGX_A | DY1_DRGX_A | 123-0001- 03 | DRUG X | STUDYDRUG | ANALYTE | 31 | ug/mL | 31 | 31 | ug/mL | PLASMA | 1.00 | 2001-02- 01T09:20 | 1 | 1 | 50 min | 3 | PT50M | Day 1 Dose | 2001-02- 01T08:30 | |
4 | ABC-123 | PC | ABC-123- 0001 | 4 | DY1_DRGX | DY1_DRGX | DY1_DRGX_A | DY1_DRGX_A | 123-0001- 04 | DRUG X | STUDYDRUG | ANALYTE | 38 | ug/mL | 38 | 38 | ug/mL | PLASMA | 1.00 | 2001-02- 01T09:45 | 1 | 1 | 75 min | 4 | PT1H15M | Day 1 Dose | 2001-02- 01T08:30 | |
5 | ABC-123 | PC | ABC-123- 0001 | 5 | DY1_DRGX | DY1_DRGX | DY1_DRGX_A | DY1_DRGX_B | 123-0001- 05 | DRUG X | STUDYDRUG | ANALYTE | 45 | ug/mL | 45 | 45 | ug/mL | PLASMA | 1.00 | 2001-02- 01T10:10 | 1 | 1 | 100 min | 5 | PT1H40M | Day 1 Dose | 2001-02- 01T08:30 | |
6 | ABC-123 | PC | ABC-123- 0001 | 6 | DY1_DRGX | DY1_DRGX | DY1_DRGX_A | DY1_DRGX_C | 123-0001- 06 | DRUG X | STUDYDRUG | ANALYTE | 48 | ug/mL | 48 | 48 | ug/mL | PLASMA | 1.00 | 2001-02- 01T10:35 | 1 | 1 | 125 min | 6 | PT2H5M | Day 1 Dose | 2001-02- 01T08:30 | |
7 | ABC-123 | PC | ABC-123- 0001 | 7 | DY1_DRGX | DY1_DRGX | DY1_DRGX_A | DY1_DRGX_A | 123-0001- 07 | DRUG X | STUDYDRUG | ANALYTE | 41 | ug/mL | 41 | 41 | ug/mL | PLASMA | 1.00 | 2001-02- 01T11:00 | 1 | 1 | 150 min | 7 | PT2H30M | Day 1 Dose | 2001-02- 01T08:30 | |
8 | ABC-123 | PC | ABC-123- 0001 | 8 | DY1_DRGX | EXCLUDE | DY1_DRGX_B | DY1_DRGX_A | 123-0001- 08 | DRUG X | STUDYDRUG | ANALYTE | 35 | ug/mL | 35 | 35 | ug/mL | PLASMA | 1.00 | 2001-02- 01T11:50 | 1 | 1 | 200 min | 8 | PT3H20M | Day 1 Dose | 2001-02- 01T08:30 | |
9 | ABC-123 | PC | ABC-123- 0001 | 9 | DY1_DRGX | EXCLUDE | DY1_DRGX_B | DY1_DRGX_A | 123-0001- 09 | DRUG X | STUDYDRUG | ANALYTE | 31 | ug/mL | 31 | 31 | ug/mL | PLASMA | 1.00 | 2001-02- 01T12:40 | 1 | 1 | 250 min | 9 | PT4H10M | Day 1 Dose | 2001-02- 01T08:30 | |
10 | ABC-123 | PC | ABC-123- 0001 | 10 | DY1_DRGX | DY1_DRGX | DY1_DRGX_A | DY1_DRGX_A | 123-0001- 10 | DRUG X | STUDYDRUG | ANALYTE | 25 | ug/mL | 25 | 25 | ug/mL | PLASMA | 1.00 | 2001-02- 01T14:45 | 1 | 1 | 375 min | 10 | PT6H15M | Day 1 Dose | 2001-02- 01T08:30 | |
11 | ABC-123 | PC | ABC-123- 0001 | 11 | DY1_DRGX | DY1_DRGX | DY1_DRGX_A | DY1_DRGX_D | 123-0001- 11 | DRUG X | STUDYDRUG | ANALYTE | 18 | ug/mL | 18 | 18 | ug/mL | PLASMA | 1.00 | 2001-02- 01T16:50 | 1 | 1 | 500 min | 11 | PT8H20M | Day 1 Dose | 2001-02- 01T08:30 | |
12 | ABC-123 | PC | ABC-123- 0001 | 12 | DY1_DRGX | DY1_DRGX | DY1_DRGX_A | DY1_DRGX_D | 123-0001- 12 | DRUG X | STUDYDRUG | ANALYTE | 12 | ug/mL | 12 | 12 | ug/mL | PLASMA | 1.00 | 2001-02- 01T18:30 | 1 | 1 | 600 min | 12 | PT10H | Day 1 Dose | 2001-02- 01T08:30 | |
13 | ABC-123 | PC | ABC-123- 0001 | 13 | DY8_DRGX | DY8_DRGX | DY8_DRGX | DY8_DRGX | 123-0002- 13 | DRUG X | STUDYDRUG | ANALYTE | 10 | ug/mL | 10 | 10 | ug/mL | PLASMA | 1.00 | 2001-02- 08T08:35 | 8 | 8 | 5 min | 1 | PT5M | Day 8 Dose | 2001-02- 08T08:30 |
Row | STUDYID | DOMAIN | USUBJID | PCSEQ | PCGRPID1 | PCGRPID2 | PCGRPID3 | PCGRPID4 | PCREFID | PCTESTCD | PCTEST | PCCAT | PCORRES | PCORRESU | PCSTRESC | PCSTRESN | PCSTRESU | PCSPEC | PCBLFL | PCLLOQ | PCDTC | PCDY | PCNOMDY | PCTPT | PCTPTNUM | PCELTM | PCTPTREF | PCRFTDTC |
14 | ABC-123 | PC | ABC-123- 0001 | 14 | DY8_DRGX | DY8_DRGX | DY8_DRGX | DY8_DRGX | 123-0002- 14 | DRUG X | STUDYDRUG | ANALYTE | 21 | ug/mL | 21 | 21 | ug/mL | PLASMA | 1.00 | 2001-02- 08T08:55 | 8 | 8 | 25 min | 2 | PT25M | Day 8 Dose | 2001-02- 08T08:30 | |
15 | ABC-123 | PC | ABC-123- 0001 | 15 | DY8_DRGX | DY8_DRGX | DY8_DRGX | DY8_DRGX | 123-0002- 15 | DRUG X | STUDYDRUG | ANALYTE | 32 | ug/mL | 32 | 32 | ug/mL | PLASMA | 1.00 | 2001-02- 08T09:20 | 8 | 8 | 50 min | 3 | PT50M | Day 8 Dose | 2001-02- 08T08:30 | |
16 | ABC-123 | PC | ABC-123- 0001 | 16 | DY8_DRGX | DY8_DRGX | DY8_DRGX | DY8_DRGX | 123-0002- 16 | DRUG X | STUDYDRUG | ANALYTE | 39 | ug/mL | 39 | 39 | ug/mL | PLASMA | 1.00 | 2001-02- 08T09:45 | 8 | 8 | 75 min | 4 | PT1H15M | Day 8 Dose | 2001-02- 08T08:30 | |
17 | ABC-123 | PC | ABC-123- 0001 | 17 | DY8_DRGX | DY8_DRGX | DY8_DRGX | DY8_DRGX | 123-0002- 17 | DRUG X | STUDYDRUG | ANALYTE | 46 | ug/mL | 46 | 46 | ug/mL | PLASMA | 1.00 | 2001-02- 08T10:10 | 8 | 8 | 100 min | 5 | PT1H40M | Day 8 Dose | 2001-02- 08T08:30 | |
18 | ABC-123 | PC | ABC-123- 0001 | 18 | DY8_DRGX | DY8_DRGX | DY8_DRGX | DY8_DRGX | 123-0002- 18 | DRUG X | STUDYDRUG | ANALYTE | 48 | ug/mL | 48 | 48 | ug/mL | PLASMA | 1.00 | 2001-02- 08T10:35 | 8 | 8 | 125 min | 6 | PT2H5M | Day 8 Dose | 2001-02- 08T08:30 | |
19 | ABC-123 | PC | ABC-123- 0001 | 19 | DY8_DRGX | DY8_DRGX | DY8_DRGX | DY8_DRGX | 123-0002- 19 | DRUG X | STUDYDRUG | ANALYTE | 40 | ug/mL | 40 | 40 | ug/mL | PLASMA | 1.00 | 2001-02- 08T11:00 | 8 | 8 | 150 min | 7 | PT2H30M | Day 8 Dose | 2001-02- 08T08:30 | |
20 | ABC-123 | PC | ABC-123- 0001 | 20 | DY8_DRGX | DY8_DRGX | DY8_DRGX | DY8_DRGX | 123-0002- 20 | DRUG X | STUDYDRUG | ANALYTE | 35 | ug/mL | 35 | 35 | ug/mL | PLASMA | 1.00 | 2001-02- 08T11:50 | 8 | 8 | 200 min | 8 | PT3H20M | Day 8 Dose | 2001-02- 08T08:30 | |
21 | ABC-123 | PC | ABC-123- 0001 | 21 | DY8_DRGX | DY8_DRGX | DY8_DRGX | DY8_DRGX | 123-0002- 21 | DRUG X | STUDYDRUG | ANALYTE | 30 | ug/mL | 30 | 30 | ug/mL | PLASMA | 1.00 | 2001-02- 08T12:40 | 8 | 8 | 250 min | 9 | PT4H10M | Day 8 Dose | 2001-02- 08T08:30 | |
22 | ABC-123 | PC | ABC-123- 0001 | 22 | DY8_DRGX | DY8_DRGX | DY8_DRGX | DY8_DRGX | 123-0002- 22 | DRUG X | STUDYDRUG | ANALYTE | 24 | ug/mL | 24 | 24 | ug/mL | PLASMA | 1.00 | 2001-02- 08T14:45 | 8 | 8 | 375 min | 10 | PT6H15M | Day 8 Dose | 2001-02- 08T08:30 | |
23 | ABC-123 | PC | ABC-123- 0001 | 23 | DY8_DRGX | DY8_DRGX | DY8_DRGX | DY8_DRGX | 123-0002- 23 | DRUG X | STUDYDRUG | ANALYTE | 17 | ug/mL | 17 | 17 | ug/mL | PLASMA | 1.00 | 2001-02- 08T16:50 | 8 | 8 | 500 min | 11 | PT8H20M | Day 8 Dose | 2001-02- 08T08:30 | |
24 | ABC-123 | PC | ABC-123- 0001 | 24 | DY8_DRGX | DY8_DRGX | DY8_DRGX | DY8_DRGX | 123-0002- 24 | DRUG X | STUDYDRUG | ANALYTE | 11 | ug/mL | 11 | 11 | ug/mL | PLASMA | 1.00 | 2001-02- 08T18:30 | 8 | 8 | 600 min | 12 | PT10H | Day 8 Dose | 2001-02- 08T08:30 |
pp.xpt
Row | STUDYID | DOMAIN | USUBJID | PPSEQ | PPGRPID1 | PPGRPID2 | PPGRPID3 | PPGRPID4 | PPTESTCD | PPTEST | PPCAT | PPORRES | PPORRESU | PPSTRESC | PPSTRESN | PPSTRESU | PPSPEC | PPNOMDY | PPRFTDTC |
1 | ABC-123 | PP | ABC-123-0001 | 1 | DY1DRGX | DY1DRGX | DY1DRGX_A | TMAX | TMAX | Time of CMAX | DRUG X | 1.87 | h | 1.87 | 1.87 | h | PLASMA | 1 | 2001-02-01T08:35 |
2 | ABC-123 | PP | ABC-123-0001 | 2 | DY1DRGX | DY1DRGX | DY1DRGX_A | CMAX | CMAX | Max Conc | DRUG X | 44.5 | ng/mL | 44.5 | 44.5 | ng/mL | PLASMA | 1 | 2001-02-01T08:35 |
3 | ABC-123 | PP | ABC-123-0001 | 3 | DY1DRGX | DY1DRGX | DY1DRGX_A | AUC | AUCALL | AUC All | DRUG X | 294.7 | h*ug/mL | 294.7 | 294.7 | h*ug/mL | PLASMA | 1 | 2001-02-01T08:35 |
4 | ABC-123 | PP | ABC-123-0001 | 5 | DY1DRGX | DY1DRGX | DY1DRGX_HALF | OTHER | LAMZHL | Half-Life Lambda z | DRUG X | 4.69 | h | 4.69 | 4.69 | h | PLASMA | 1 | 2001-02-01T08:35 |
5 | ABC-123 | PP | ABC-123-0001 | 6 | DY1DRGX | DY1DRGX | DY1DRGX_A | OTHER | VZO | Vz Obs | DRUG X | 10.9 | L | 10.9 | 10.9 | L | PLASMA | 1 | 2001-02-01T08:35 |
6 | ABC-123 | PP | ABC-123-0001 | 7 | DY1DRGX | DY1DRGX | DY1DRGX_A | OTHER | CLO | Total CL Obs | DRUG X | 1.68 | L/h | 1.68 | 1.68 | L/h | PLASMA | 1 | 2001-02-01T08:35 |
7 | ABC-123 | PP | ABC-123-0001 | 8 | DY8DRGX | DY8DRGX | DY8DRGX | DY8DRGX | TMAX | Time of CMAX | DRUG X | 1.91 | h | 1.91 | 1.91 | h | PLASMA | 8 | 2001-02-08T08:35 |
8 | ABC-123 | PP | ABC-123-0001 | 9 | DY8DRGX | DY8DRGX | DY8DRGX | DY8DRGX | CMAX | Max Conc | DRUG X | 46.0 | ng/mL | 46.0 | 46.0 | ng/mL | PLASMA | 8 | 2001-02-08T08:35 |
9 | ABC-123 | PP | ABC-123-0001 | 10 | DY8DRGX | DY8DRGX | DY8DRGX | DY8DRGX | AUCALL | AUC All | DRUG X | 289.0 | h*ug/mL | 289.0 | 289.0 | h*ug/mL | PLASMA | 8 | 2001-02-08T08:35 |
10 | ABC-123 | PP | ABC-123-0001 | 12 | DY8DRGX | DY8DRGX | DY8DRGX | DY8DRGX | LAMZHL | Half-Life Lambda z | DRUG X | 4.50 | h | 4.50 | 4.50 | h | PLASMA | 8 | 2001-02-08T08:35 |
11 | ABC-123 | PP | ABC-123-0001 | 13 | DY8DRGX | DY8DRGX | DY8DRGX | DY8DRGX | VZO | Vz Obs | DRUG X | 10.7 | L | 10.7 | 10.7 | L | PLASMA | 8 | 2001-02-08T08:35 |
12 | ABC-123 | PP | ABC-123-0001 | 14 | DY8DRGX | DY8DRGX | DY8DRGX | DY8DRGX | CLO | Total CL Obs | DRUG X | 1.75 | L/h | 1.75 | 1.75 | L/h | PLASMA | 8 | 2001-02-08T08:35 |
Example 1
All PC records used to calculate all pharmacokinetic parameters.
relrec.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
1 | ABC-123 | PC | ABC-123-0001 | PCGRPID | DY1_DRGX | 1 | |
2 | ABC-123 | PP | ABC-123-0001 | PPGRPID | DY1DRGX | 1 |
relrec.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
1 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 1 | 1 | |
2 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 2 | 1 | |
3 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 3 | 1 | |
4 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 4 | 1 | |
5 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 5 | 1 | |
6 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 6 | 1 | |
7 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 7 | 1 | |
8 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 8 | 1 | |
9 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 9 | 1 | |
10 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 10 | 1 | |
11 | ABC-123 | PC | ABC-123-0001 | PPGRPID | DY1DRGX | 1 |
relrec.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
1 | ABC-123 | PC | ABC-123-0001 | PCGRPID | DY1_DRGX | 1 | |
2 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 1 | 1 | |
3 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 2 | 1 | |
4 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 3 | 1 | |
5 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 4 | 1 | |
6 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 5 | 1 | |
7 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 6 | 1 | |
8 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 7 | 1 | |
9 | ABC-123 | PC | ABC-123-0001 | PCGRPID | DY8_DRGX | 2 | |
10 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 8 | 2 | |
11 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 9 | 2 | |
12 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 10 | 2 | |
13 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 11 | 2 | |
14 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 12 | 2 | |
15 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 13 | 2 | |
16 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 14 | 2 |
relrec.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
1 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 1 | 1 | |
2 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 2 | 1 | |
3 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 3 | 1 | |
4 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 4 | 1 | |
5 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 5 | 1 | |
6 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 6 | 1 | |
7 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 7 | 1 | |
8 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 8 | 1 | |
9 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 9 | 1 | |
10 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 10 | 1 | |
11 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 11 | 1 | |
12 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 12 | 1 | |
13 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 1 | 1 | |
14 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 2 | 1 | |
15 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 3 | 1 | |
16 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 4 | 1 | |
17 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 5 | 1 | |
18 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 6 | 1 | |
19 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 7 | 1 | |
20 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 13 | 2 | |
21 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 14 | 2 | |
22 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 15 | 2 | |
23 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 16 | 2 | |
24 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 17 | 2 | |
25 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 18 | 2 | |
26 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 19 | 2 | |
27 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 20 | 2 | |
28 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 21 | 2 | |
29 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 22 | 2 | |
30 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 23 | 2 | |
31 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 24 | 2 | |
32 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 8 | 2 | |
33 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 9 | 2 | |
34 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 10 | 2 | |
35 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 11 | 2 | |
36 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 12 | 2 | |
37 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 13 | 2 | |
38 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 14 | 2 |
Example 2
Only some records in PC used to calculate all pharmacokinetic parameters: Time points 8 and 9 on day 1 were not used for any pharmacokinetic parameters.
Day 8 relationships are the same as those shown in Example 1.
= DY1DRGX. PC records with PCGRPID = EXCLUDE were not used.
relrec.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
1 | ABC-123 | PC | ABC-123-0001 | PCGRPID | DY1_DRGX | 1 | |
2 | ABC-123 | PP | ABC-123-0001 | PPGRPID | DY1DRGX | 1 |
Day 8 relationships are the same as those shown in Example 1.
relrec.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
1 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 1 | 1 | |
2 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 2 | 1 | |
3 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 3 | 1 | |
4 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 4 | 1 | |
5 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 5 | 1 | |
6 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 6 | 1 | |
7 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 7 | 1 | |
8 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 10 | 1 | |
9 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 11 | 1 | |
10 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 12 | 1 | |
11 | ABC-123 | PP | ABC-123-0001 | PPGRPID | DY1DRGX | 1 |
Day 8 relationships are the same as those shown in Example 1.
relrec.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
1 | ABC-123 | PC | ABC-123-0001 | PCGRPID | DY1_DRGX | 1 | |
2 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 1 | 1 | |
3 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 2 | 1 | |
4 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 3 | 1 | |
5 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 4 | 1 | |
6 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 5 | 1 | |
7 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 6 | 1 | |
8 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 7 | 1 |
Day 8 relationships are the same as those shown in Example 1.
relrec.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
1 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 1 | 1 | |
2 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 2 | 1 | |
3 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 3 | 1 | |
4 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 4 | 1 | |
5 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 5 | 1 | |
6 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 6 | 1 | |
7 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 7 | 1 |
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
8 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 10 | 1 | |
9 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 11 | 1 | |
10 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 12 | 1 | |
11 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 1 | 1 | |
12 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 2 | 1 | |
13 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 3 | 1 | |
14 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 4 | 1 | |
15 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 5 | 1 | |
16 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 6 | 1 | |
17 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 7 | 1 |
Example 3
Only some records in PC used to calculate some parameters: Time points 8 and 9 on day 1 were not used for half- life calculations, but were used for other parameters.
Day 8 relationships are the same as those shown in Example 1.
relrec.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
1 | ABC-123 | PC | ABC-123-0001 | PCGRPID | DY1_DRGX_A | 1 | |
2 | ABC-123 | PC | ABC-123-0001 | PCGRPID | DY1_DRGX_B | 1 | |
3 | ABC-123 | PP | ABC-123-0001 | PPGRPID | DY1DRGX_A | 1 | |
4 | ABC-123 | PC | ABC-123-0001 | PCGRPID | DY1_DRGX_A | 2 | |
5 | ABC-123 | PP | ABC-123-0001 | PPGRPID | DY1DRGX_HALF | 2 |
Day 8 relationships are the same as those shown in Example 1.
relrec.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
1 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 1 | 1 | |
2 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 2 | 1 | |
3 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 3 | 1 | |
4 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 4 | 1 | |
5 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 5 | 1 | |
6 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 6 | 1 | |
7 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 7 | 1 | |
8 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 8 | 1 | |
9 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 9 | 1 | |
10 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 10 | 1 | |
11 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 11 | 1 | |
12 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 12 | 1 | |
13 | ABC-123 | PP | ABC-123-0001 | PPGRPID | DY1DRGX_A | 1 | |
14 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 1 | 2 | |
15 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 2 | 2 | |
16 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 3 | 2 |
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
17 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 4 | 2 | |
18 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 5 | 2 | |
19 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 6 | 2 | |
20 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 7 | 2 | |
21 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 10 | 2 | |
22 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 11 | 2 | |
23 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 12 | 2 | |
24 | ABC-123 | PP | ABC-123-0001 | PPGRPID | DY1DRGX_HALF | 2 |
Day 8 relationships are the same as those shown in Example 1.
relrec.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
1 | ABC-123 | PC | ABC-123-0001 | PCGRPID | DY1_DRGX_A | 1 | |
2 | ABC-123 | PC | ABC-123-0001 | PCGRPID | DY1_DRGX_B | 1 | |
3 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 1 | 1 | |
4 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 2 | 1 | |
5 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 3 | 1 | |
6 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 6 | 1 | |
7 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 7 | 1 | |
8 | ABC-123 | PC | ABC-123-0001 | PCGRPID | DY1_DRGX_A | 2 | |
9 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 4 | 2 | |
10 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 5 | 2 |
Day 8 relationships are the same as those shown in Example 1.
relrec.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
1 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 1 | 1 | |
2 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 2 | 1 | |
3 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 3 | 1 | |
4 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 4 | 1 | |
5 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 5 | 1 | |
6 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 6 | 1 | |
7 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 7 | 1 | |
8 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 8 | 1 | |
9 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 9 | 1 | |
10 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 10 | 1 | |
11 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 11 | 1 | |
12 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 12 | 1 | |
13 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 1 | 1 | |
14 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 2 | 1 | |
15 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 3 | 1 | |
16 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 6 | 1 | |
17 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 7 | 1 |
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
18 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 1 | 2 | |
19 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 2 | 2 | |
20 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 3 | 2 | |
21 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 4 | 2 | |
22 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 5 | 2 | |
23 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 6 | 2 | |
24 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 7 | 2 | |
25 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 10 | 2 | |
26 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 11 | 2 | |
27 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 12 | 2 | |
28 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 4 | 2 | |
29 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 5 | 2 |
Example 4
Only some records in PC used to calculate parameters: Time point 5 was excluded from Tmax, 6 from Cmax, and 11 and 12 from AUC.
Day 8 relationships are the same as those shown in Example 1.
relrec.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
1 | ABC-123 | PP | ABC-123-0001 | PPGRPID | TMAX | 1 | |
2 | ABC-123 | PC | ABC-123-0001 | PCGRPID | DY1DRGX_A | 1 | |
3 | ABC-123 | PC | ABC-123-0001 | PCGRPID | DY1DRGX_C | 1 | |
4 | ABC-123 | PC | ABC-123-0001 | PCGRPID | DY1DRGX_D | 1 | |
5 | ABC-123 | PP | ABC-123-0001 | PPGRPID | CMAX | 2 | |
6 | ABC-123 | PC | ABC-123-0001 | PCGRPID | DY1DRGX_A | 2 | |
7 | ABC-123 | PC | ABC-123-0001 | PCGRPID | DY1DRGX_B | 2 | |
8 | ABC-123 | PC | ABC-123-0001 | PCGRPID | DY1DRGX_D | 2 | |
9 | ABC-123 | PP | ABC-123-0001 | PPGRPID | AUC | 3 | |
10 | ABC-123 | PC | ABC-123-0001 | PCGRPID | DY1DRGX_A | 3 | |
11 | ABC-123 | PC | ABC-123-0001 | PCGRPID | DY1DRGX_B | 3 | |
12 | ABC-123 | PC | ABC-123-0001 | PCGRPID | DY1DRGX_C | 3 | |
13 | ABC-123 | PP | ABC-123-0001 | PPGRPID | OTHER | 4 | |
14 | ABC-123 | PC | ABC-123-0001 | PCGRPID | DY1DRGX_A | 4 | |
15 | ABC-123 | PC | ABC-123-0001 | PCGRPID | DY1DRGX_B | 4 | |
16 | ABC-123 | PC | ABC-123-0001 | PCGRPID | DY1DRGX_C | 4 | |
17 | ABC-123 | PC | ABC-123-0001 | PCGRPID | DY1DRGX_D | 4 |
Note that in this RELREC table, the single records in rows 1, 3, 5, 7, and 9, represented by their --GRPIDs (Tmax, DY1DRGX_C, Cmax, DY1DRGX_B, AUC) could have been referenced by their SEQ values, as both identify the records sufficiently. At least 2 other hybrid approaches would have been acceptable as well: using PPSEQ and PCGRPIDs whenever possible or using PPGRPID and PCSEQ values whenever possible. Method D uses only SEQ values.
Day 8 relationships are the same as those shown in Example 1.
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
1 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 1 | 1 | |
2 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 2 | 1 | |
3 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 3 | 1 | |
4 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 4 | 1 | |
5 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 6 | 1 | |
6 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 7 | 1 | |
7 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 8 | 1 | |
8 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 9 | 1 | |
9 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 10 | 1 | |
10 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 11 | 1 | |
11 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 12 | 1 | |
12 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 1 | 1 | |
13 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 1 | 2 | |
14 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 2 | 2 | |
15 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 3 | 2 | |
16 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 4 | 2 | |
17 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 5 | 2 | |
18 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 7 | 2 | |
19 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 8 | 2 | |
20 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 9 | 2 | |
21 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 10 | 2 | |
22 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 11 | 2 | |
23 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 12 | 2 | |
24 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 2 | 2 | |
25 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 1 | 3 | |
26 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 2 | 3 | |
27 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 3 | 3 | |
28 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 4 | 3 | |
29 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 5 | 3 | |
30 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 6 | 3 | |
31 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 7 | 3 | |
32 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 8 | 3 | |
33 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 9 | 3 | |
34 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 10 | 3 | |
35 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 3 | 3 | |
36 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 1 | 4 | |
37 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 2 | 4 | |
38 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 3 | 4 | |
39 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 4 | 4 | |
40 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 5 | 4 | |
41 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 6 | 4 | |
42 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 7 | 4 | |
43 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 8 | 4 | |
44 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 9 | 4 |
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
45 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 10 | 4 | |
46 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 11 | 4 | |
47 | ABC-123 | PC | ABC-123-0001 | PCSEQ | 12 | 4 | |
48 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 4 | 4 | |
49 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 5 | 4 | |
50 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 6 | 4 | |
51 | ABC-123 | PP | ABC-123-0001 | PPSEQ | 7 | 4 |
Suggestions for Implementing RELREC in the Submission of Pharmacokinetic Data
If a sponsor decides to create RELREC records, determine which of the scenarios best reflects how PP data are related to PC data. Questions that should be considered include:
Do all parameters for each pharmacokinetic profile use all concentrations for all subjects? If so, and you decide to create RELREC records showing this explicitly, create a PPGRPID value for all PP records and a PCGRPID value for all PC records for each profile for each subject, analyte, and reference time point. Decide whether to relate datasets (Section 8.1, Relating Groups of Records Within a Domain Using the -- GRPID Variable) or records (Section 8.2, Relating Records - RELREC, and Example 1). If choosing the latter, create records in RELREC for each PCGRPID value and each PPGRPID value (Method A). Use RELID to show which PCGRPID and PPGRPID records are related. Consider RELREC Methods B, C, and D as applicable.
Do all parameters use the same concentrations, although maybe not all of them (Example 2)? If so, create a single PPGRPID value for all PP records, and 2 PCGRPID values for the PC records: a PCGRPID value for ones that were used and a PCGRPID value for those that were not used. Create records in RELREC for each PCGRPID value and each PPGRPID value (Method A). Use RELID to show which PCGRPID and PPGRPID records are related. Consider RELREC Methods B, C, and D as applicable.
Do any parameters use the same concentrations, but not as consistently as shown in Examples 1 and 2? If so, refer to Example 3. Assign a GRPID value to the PP records that use the same concentrations. More than one PPGRPID value may be necessary. Assign as many PCGRPID values in the PC domain as needed to group these records. Create records in RELREC for each PCGRPID value and each PPGRPID value (Method A). Use RELID to show which PCGRPID and PPGRPID records are related. Consider RELREC Methods B, C, and D as applicable.
If none of these applies, or the data become difficult to group, then start with Example 4, and decide which RELREC method would be easiest to implement and represent.
Relating the datasets (as described in Section 8, Representing Relationships and Data) is the simplest method; however, all time-point concentrations in PC must be used to calculate all parameters for all subjects. If datasets cannot be related, then individual subject records must be related. In either case, the values of PCGRPID and PPGRPID must take into account multiple analytes and multiple reference time points, if these exist.
Method A is clearly the most efficient in terms of having the least number of RELREC records, but it does require the assignment of --GRPID values (which are optional) in both the PC and PP datasets. Method D, in contrast, does not require the assignment of --GRPID values, but relies instead on the required --SEQ values in both datasets to relate the records. Although Method D results in the largest number of RELREC records compared to the other methods, it may be the easiest to implement consistently across the range of complexities shown in the examples. Two additional methods, Methods B and C, are also shown for Examples 1-3, representing hybrid approaches using
--GRPID values in only one dataset (PP and PC, respectively) and --SEQ values for the other. These methods are best suited for sponsors who want to minimize the number of RELREC records while not having to assign --GRPID values in both domains. Methods B and C would not be ideal, however, if one expected complex scenarios as shown in Example 4.
Please note that an attempt has been made to approximate real pharmacokinetic data; however, the example values are not intended to reflect data used for actual analysis. When certain time-point concentrations have been omitted
from PP calculations in Examples 2-4, the actual parameter values in the PP dataset have not been recalculated from those in Example 1 to reflect those omissions.
This version of SENDIG provides cross-domain examples for pharmacokinetic data. These new examples are provided to show the relationship between concentration data and their relevant parameters. Each example takes a study and shows how the Exposure (EX), PC, PP, supplemental qualifiers, and Pool Definition (POOLDEF) domains would work together for that study. The examples demonstrate both individual sampling and sparse sampling but do not address Latin square study designs, which may require different implementation of certain timing variables.
PC PP Cross-domain Example 1
This example shows data for 1 animal subject, where all timing variables are populated as the information was readily available electronically. The subject was dosed daily and sampled for 2 profiles, starting day 1 and day 7. A full profile was obtained from the subject on both occasions and analyzed for parent compound (PCTESTCD = XYZ123) and 2 metabolites (PCTESTCD = XYZ345 and XYZ456).
PC PP Cross-domain Example 1: EX
The Exposure (EX) records are provided to show the relationship between the time recorded in the dosing records (EXSTDTC) and the PCRFTDTC and PPRFTDTC.
ex.xpt
Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXDOSFRQ | EXROUTE | EXLOT | EXRTV | EXVAMT | EXVAMTU | EXSTDTC | EXSTDY |
1 | ABC-123 | EX | ABC-123- 1001 | 1 | XYZ- 123 | 2.6 | mg | SOLUTION | QD | ORAL GAVAGE | XYZ123- 01 | Saline | 5 | mL | 2017-06- 20T09:49:39 | 1 |
2 | ABC-123 | EX | ABC-123- 1001 | 2 | XYZ- 123 | 2.6 | mg | SOLUTION | QD | ORAL GAVAGE | XYZ123- 01 | Saline | 5 | mL | 2017-06- 21T09:36:08 | 2 |
3 | ABC-123 | EX | ABC-123- 1001 | 3 | XYZ- 123 | 2.6 | mg | SOLUTION | QD | ORAL GAVAGE | XYZ123- 01 | Saline | 5 | mL | 2017-06- 22T09:24:26 | 3 |
4 | ABC-123 | EX | ABC-123- 1001 | 4 | XYZ- 123 | 2.7 | mg | SOLUTION | QD | ORAL GAVAGE | XYZ123- 01 | Saline | 5 | mL | 2017-06- 23T09:55:14 | 4 |
5 | ABC-123 | EX | ABC-123- 1001 | 5 | XYZ- 123 | 2.7 | mg | SOLUTION | QD | ORAL GAVAGE | XYZ123- 01 | Saline | 5 | mL | 2017-06- 24T09:42:59 | 5 |
6 | ABC-123 | EX | ABC-123- 1001 | 6 | XYZ- 123 | 2.7 | mg | SOLUTION | QD | ORAL GAVAGE | XYZ123- 01 | Saline | 5 | mL | 2017-06- 25T09:15:16 | 6 |
7 | ABC-123 | EX | ABC-123- 1001 | 7 | XYZ- 123 | 2.6 | mg | SOLUTION | QD | ORAL GAVAGE | XYZ123- 01 | Saline | 5 | mL | 2017-06- 26T09:08:40 | 7 |
PC PP Cross-domain Example 1: PC
In this example, the sponsor chose to populate PCTPTNUM with a value representing the number of hours postdose. The sponsor populated PCCAT with ANALYTE and PCSCAT to differentiate between PARENT and METABOLITE.
pc.xpt
Row | STUDYID | DOMAIN | USUBJID | PCSEQ | PCTESTCD | PCTEST | PCCAT | PCSCAT | PCORRES | PCORRESU | PCSTRESC | PCSTRESN | PCSTRESU | PCNAM | PCSPEC | PCMETHOD | PCLLOQ | PCDTC | PCDY | PCNOMDY | PCTPT | PCTPTNUM | PCELTM | PCTPTREF | PCRFTDTC |
1 | ABC-123 | PC | ABC-123- 1001 | 1 | XYZ123 | XYZ-123 | ANALYTE | PARENT | <LLOQ | ng/mL | BLQ | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 20T09:49:00 | 1 | 1 | Predose | 0 | PT0H | Day 1 Dose | 2017-06- 20T09:49:39 | |
2 | ABC-123 | PC | ABC-123- 1001 | 2 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 0.700 | ng/mL | 0.700 | 0.7 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 20T10:04:00 | 1 | 1 | 0.25 hour postdose | 0.25 | PT0.25H | Day 1 Dose | 2017-06- 20T09:49:39 |
3 | ABC-123 | PC | ABC-123- 1001 | 3 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 8.1 | ng/mL | 8.1 | 8.1 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 20T10:19:00 | 1 | 1 | 0.5 hour postdose | 0.5 | PT0.5H | Day 1 Dose | 2017-06- 20T09:49:39 |
4 | ABC-123 | PC | ABC-123- 1001 | 4 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 44.0 | ng/mL | 44.0 | 44 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 20T10:44:00 | 1 | 1 | 1 hour postdose | 1 | PT1H | Day 1 Dose | 2017-06- 20T09:49:39 |
5 | ABC-123 | PC | ABC-123- 1001 | 5 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 108 | ng/mL | 108 | 108 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 20T11:52:00 | 1 | 1 | 2 hours postdose | 2 | PT2H | Day 1 Dose | 2017-06- 20T09:49:39 |
6 | ABC-123 | PC | ABC-123- 1001 | 6 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 32.3 | ng/mL | 32.3 | 32.3 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 20T13:56:00 | 1 | 1 | 4 hours postdose | 4 | PT4H | Day 1 Dose | 2017-06- 20T09:49:39 |
7 | ABC-123 | PC | ABC-123- 1001 | 7 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 4.75 | ng/mL | 4.75 | 4.75 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 20T17:53:00 | 1 | 1 | 8 hours postdose | 8 | PT8H | Day 1 Dose | 2017-06- 20T09:49:39 |
8 | ABC-123 | PC | ABC-123- 1001 | 8 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 2.01 | ng/mL | 2.01 | 2.01 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 20T21:27:00 | 1 | 1 | 12 hours postdose | 12 | PT12H | Day 1 Dose | 2017-06- 20T09:49:39 |
9 | ABC-123 | PC | ABC-123- 1001 | 9 | XYZ123 | XYZ-123 | ANALYTE | PARENT | <LLOQ | ng/mL | BLQ | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 21T09:53:00 | 2 | 1 | 24 hours postdose | 24 | PT24H | Day 1 Dose | 2017-06- 20T09:49:39 | |
10 | ABC-123 | PC | ABC-123- 1001 | 10 | XYZ123 | XYZ-123 | ANALYTE | PARENT | <LLOQ | ng/mL | BLQ | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 26T09:07:00 | 7 | 7 | Predose | 0 | PT0H | Day 7 Dose | 2017-06- 26T09:08:40 | |
11 | ABC-123 | PC | ABC-123- 1001 | 11 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 7.69 | ng/mL | 7.69 | 7.69 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 26T09:23:00 | 7 | 7 | 0.25 hour postdose | 0.25 | PT0.25H | Day 7 Dose | 2017-06- 26T09:08:40 |
12 | ABC-123 | PC | ABC-123- 1001 | 12 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 39.8 | ng/mL | 39.8 | 39.8 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 26T09:37:00 | 7 | 7 | 0.5 hour postdose | 0.5 | PT0.5H | Day 7 Dose | 2017-06- 26T09:08:40 |
13 | ABC-123 | PC | ABC-123- 1001 | 13 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 140 | ng/mL | 140 | 140 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 26T10:06:00 | 7 | 7 | 1 hour postdose | 1 | PT1H | Day 7 Dose | 2017-06- 26T09:08:40 |
14 | ABC-123 | PC | ABC-123- 1001 | 14 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 116 | ng/mL | 116 | 116 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 26T10:56:00 | 7 | 7 | 2 hours postdose | 2 | PT2H | Day 7 Dose | 2017-06- 26T09:08:40 |
15 | ABC-123 | PC | ABC-123- 1001 | 15 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 52.2 | ng/mL | 52.2 | 52.2 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 26T13:08:00 | 7 | 7 | 4 hours postdose | 4 | PT4H | Day 7 Dose | 2017-06- 26T09:08:40 |
16 | ABC-123 | PC | ABC-123- 1001 | 16 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 18.3 | ng/mL | 18.3 | 18.3 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 26T17:07:00 | 7 | 7 | 8 hours postdose | 8 | PT8H | Day 7 Dose | 2017-06- 26T09:08:40 |
17 | ABC-123 | PC | ABC-123- 1001 | 17 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 14.4 | ng/mL | 14.4 | 14.4 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 26T21:26:00 | 7 | 7 | 12 hours postdose | 12 | PT12H | Day 7 Dose | 2017-06- 26T09:08:40 |
18 | ABC-123 | PC | ABC-123- 1001 | 18 | XYZ123 | XYZ-123 | ANALYTE | PARENT | 2.01 | ng/mL | 2.01 | 2.01 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 27T08:13:00 | 8 | 7 | 24 hours postdose | 24 | PT24H | Day 7 Dose | 2017-06- 26T09:08:40 |
19 | ABC-123 | PC | ABC-123- 1001 | 19 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | <LLOQ | ng/mL | BLQ | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 20T09:49:00 | 1 | 1 | Predose | 0 | PT0H | Day 1 Dose | 2017-06- 20T09:49:39 | |
20 | ABC-123 | PC | ABC-123- 1001 | 20 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | <LLOQ | ng/mL | BLQ | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 20T10:04:00 | 1 | 1 | 0.25 hour postdose | 0.25 | PT0.25H | Day 1 Dose | 2017-06- 20T09:49:39 | |
21 | ABC-123 | PC | ABC-123- 1001 | 21 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 11.6 | ng/mL | 11.6 | 11.6 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 20T10:19:00 | 1 | 1 | 0.5 hour postdose | 0.5 | PT0.5H | Day 1 Dose | 2017-06- 20T09:49:39 |
22 | ABC-123 | PC | ABC-123- 1001 | 22 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 78.7 | ng/mL | 78.7 | 78.7 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 20T10:44:00 | 1 | 1 | 1 hour postdose | 1 | PT1H | Day 1 Dose | 2017-06- 20T09:49:39 |
23 | ABC-123 | PC | ABC-123- 1001 | 23 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 699 | ng/mL | 699 | 699 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 20T11:52:00 | 1 | 1 | 2 hours postdose | 2 | PT2H | Day 1 Dose | 2017-06- 20T09:49:39 |
24 | ABC-123 | PC | ABC-123- 1001 | 24 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 205 | ng/mL | 205 | 205 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 20T13:56:00 | 1 | 1 | 4 hours postdose | 4 | PT4H | Day 1 Dose | 2017-06- 20T09:49:39 |
Row | STUDYID | DOMAIN | USUBJID | PCSEQ | PCTESTCD | PCTEST | PCCAT | PCSCAT | PCORRES | PCORRESU | PCSTRESC | PCSTRESN | PCSTRESU | PCNAM | PCSPEC | PCMETHOD | PCLLOQ | PCDTC | PCDY | PCNOMDY | PCTPT | PCTPTNUM | PCELTM | PCTPTREF | PCRFTDTC |
25 | ABC-123 | PC | ABC-123- 1001 | 25 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 21.8 | ng/mL | 21.8 | 21.8 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 20T17:53:00 | 1 | 1 | 8 hours postdose | 8 | PT8H | Day 1 Dose | 2017-06- 20T09:49:39 |
26 | ABC-123 | PC | ABC-123- 1001 | 26 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 6.20 | ng/mL | 6.20 | 6.2 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 20T21:27:00 | 1 | 1 | 12 hours postdose | 12 | PT12H | Day 1 Dose | 2017-06- 20T09:49:39 |
27 | ABC-123 | PC | ABC-123- 1001 | 27 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 1.66 | ng/mL | 1.66 | 1.66 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 21T09:53:00 | 2 | 1 | 24 hours postdose | 24 | PT24H | Day 1 Dose | 2017-06- 20T09:49:39 |
28 | ABC-123 | PC | ABC-123- 1001 | 28 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 2.05 | ng/mL | 2.05 | 2.05 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 26T09:07:00 | 7 | 7 | Predose | 0 | PT0H | Day 7 Dose | 2017-06- 26T09:08:40 |
29 | ABC-123 | PC | ABC-123- 1001 | 29 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 9.29 | ng/mL | 9.29 | 9.29 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 26T09:23:00 | 7 | 7 | 0.25 hour postdose | 0.25 | PT0.25H | Day 7 Dose | 2017-06- 26T09:08:40 |
30 | ABC-123 | PC | ABC-123- 1001 | 30 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 39.8 | ng/mL | 39.8 | 39.8 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 26T09:37:00 | 7 | 7 | 0.5 hour postdose | 0.5 | PT0.5H | Day 7 Dose | 2017-06- 26T09:08:40 |
31 | ABC-123 | PC | ABC-123- 1001 | 31 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 89.6 | ng/mL | 89.6 | 89.6 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 26T10:06:00 | 7 | 7 | 1 hour postdose | 1 | PT1H | Day 7 Dose | 2017-06- 26T09:08:40 |
32 | ABC-123 | PC | ABC-123- 1001 | 32 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 92.8 | ng/mL | 92.8 | 92.8 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 26T10:56:00 | 7 | 7 | 2 hours postdose | 2 | PT2H | Day 7 Dose | 2017-06- 26T09:08:40 |
33 | ABC-123 | PC | ABC-123- 1001 | 33 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 56.8 | ng/mL | 56.8 | 56.8 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 26T13:08:00 | 7 | 7 | 4 hours postdose | 4 | PT4H | Day 7 Dose | 2017-06- 26T09:08:40 |
34 | ABC-123 | PC | ABC-123- 1001 | 34 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 15.2 | ng/mL | 15.2 | 15.2 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 26T17:07:00 | 7 | 7 | 8 hours postdose | 8 | PT8H | Day 7 Dose | 2017-06- 26T09:08:40 |
35 | ABC-123 | PC | ABC-123- 1001 | 35 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 10.8 | ng/mL | 10.8 | 10.8 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 26T21:26:00 | 7 | 7 | 12 hours postdose | 12 | PT12H | Day 7 Dose | 2017-06- 26T09:08:40 |
36 | ABC-123 | PC | ABC-123- 1001 | 36 | XYZ345 | XYZ-345 | ANALYTE | METABOLITE | 3.66 | ng/mL | 3.66 | 3.66 | ng/mL | BIOANALYSIS LAB X | PLASMA | LC/MS/MS | 0.6 | 2017-06- 27T08:13:00 | 8 | 7 | 24 hours postdose | 24 | PT24H | Day 7 Dose | 2017-06- 26T09:08:40 |
PC PP Cross-domain Example 1: PP
In this example, PPTPREF has been populated with values giving the day of dose. In this case there is only 1 daily dose; therefore, PPTPTREF populated with “Day 1 Dose” is sufficient to explain the reference and matches PCTPTREF.
pp.xpt
Row | STUDYID | DOMAIN | USUBJID | PPSEQ | PPTESTCD | PPTEST | PPCAT | PPSCAT | PPORRES | PPORRESU | PPSTRESC | PPSTRESN | PPSTRESU | PPSTAT | PPREASND | PPSPEC | PPNOMDY | PPTPTREF | PPRFTDTC | PPSTINT | PPENINT |
1 | ABC-123 | PP | ABC-123-1001 | 1 | TMAX | Time of CMAX | XYZ-123 | NON-COMPARTMENTAL | 2 | h | 2 | 2 | h | PLASMA | 1 | Day 1 Dose | 2017-06-20T09:49:39 | ||||
2 | ABC-123 | PP | ABC-123-1001 | 2 | CMAX | Max Conc | XYZ-123 | NON-COMPARTMENTAL | 108 | ng/mL | 108 | 108 | ng/mL | PLASMA | 1 | Day 1 Dose | 2017-06-20T09:49:39 | ||||
3 | ABC-123 | PP | ABC-123-1001 | 3 | AUCLST | AUC to Last Nonzero Conc | XYZ-123 | NON-COMPARTMENTAL | 318 | h*ng/mL | 318 | 318 | h*ng/mL | PLASMA | 1 | Day 1 Dose | 2017-06-20T09:49:39 | ||||
4 | ABC-123 | PP | ABC-123-1001 | 4 | TLST | Time of Last Nonzero Conc | XYZ-123 | NON-COMPARTMENTAL | 12 | h | 12 | 12 | h | PLASMA | 1 | Day 1 Dose | 2017-06-20T09:49:39 | ||||
5 | ABC-123 | PP | ABC-123-1001 | 5 | AUCINT | AUC from T1 to T2 | XYZ-123 | NON-COMPARTMENTAL | 330 | h*ng/mL | 330 | 330 | h*ng/mL | PLASMA | 1 | Day 1 Dose | 2017-06-20T09:49:39 | PT0H | PT24H | ||
6 | ABC-123 | PP | ABC-123-1001 | 6 | TMAX | Time of CMAX | XYZ-123 | NON-COMPARTMENTAL | 1 | h | 1 | 1 | h | PLASMA | 7 | Day 7 Dose | 2017-06-26T09:08:40 | ||||
7 | ABC-123 | PP | ABC-123-1001 | 7 | CMAX | Max Conc | XYZ-123 | NON-COMPARTMENTAL | 140 | ng/mL | 140 | 140 | ng/mL | PLASMA | 7 | Day 7 Dose | 2017-06-26T09:08:40 | ||||
8 | ABC-123 | PP | ABC-123-1001 | 8 | AUCLST | AUC to Last Nonzero Conc | XYZ-123 | NON-COMPARTMENTAL | 653 | h*ng/mL | 653 | 653 | h*ng/mL | PLASMA | 7 | Day 7 Dose | 2017-06-26T09:08:40 | ||||
9 | ABC-123 | PP | ABC-123-1001 | 9 | TLST | Time of Last Nonzero Conc | XYZ-123 | NON-COMPARTMENTAL | 24 | h | 24 | 24 | h | PLASMA | 7 | Day 7 Dose | 2017-06-26T09:08:40 | ||||
10 | ABC-123 | PP | ABC-123-1001 | 10 | AUCINT | AUC from T1 to T2 | XYZ-123 | NON-COMPARTMENTAL | 653 | h*ng/mL | 653 | 653 | h*ng/mL | PLASMA | 7 | Day 7 Dose | 2017-06-26T09:08:40 | PT0H | PT24H | ||
11 | ABC-123 | PP | ABC-123-1001 | 11 | ARCMAX | Accumulation Ratio Cmax | XYZ-123 | NON-COMPARTMENTAL | 1.30 | RATIO | 1.30 | 1.30 | RATIO | PLASMA | 7 | Day 7 Dose | 2017-06-26T09:08:40 | ||||
12 | ABC-123 | PP | ABC-123-1001 | 12 | AUCLST | AUC to Last Nonzero Conc | XYZ-345 | NON-COMPARTMENTAL | 1874 | h*ng/mL | 1874 | 1874 | h*ng/mL | PLASMA | 1 | Day 1 Dose | 2017-06-20T09:49:39 | ||||
13 | ABC-123 | PP | ABC-123-1001 | 13 | TLST | Time of Last Nonzero Conc | XYZ-345 | NON-COMPARTMENTAL | 24 | h | 24 | 24 | h | PLASMA | 1 | Day 1 Dose | 2017-06-20T09:49:39 | ||||
14 | ABC-123 | PP | ABC-123-1001 | 14 | AUCLST | AUC to Last Nonzero Conc | XYZ-345 | NON-COMPARTMENTAL | 563 | h*ng/mL | 563 | 563 | h*ng/mL | PLASMA | 7 | Day 7 Dose | 2017-06-26T09:08:40 | ||||
15 | ABC-123 | PP | ABC-123-1001 | 15 | TLST | Time of Last Nonzero Conc | XYZ-345 | NON-COMPARTMENTAL | 24 | h | 24 | 24 | h | PLASMA | 7 | Day 7 Dose | 2017-06-26T09:08:40 |
PC PP Cross-domain Example 1: SUPPPC
This example shows a SUPPC domain to specify the PCCALCN value used for the PC records where the result fell below the limit of quantitation.
supppc.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
1 | ABC-123 | PC | ABC-123-1001 | PCSTRESC | BLQ | PCCALCN | Numeric Interpretation for Calculations | 0 | DERIVED |
PC PP Cross-domain Example 2
This example shows data for 1 animal subject, where only the minimal amount of timing information was readily available electronically. The subject was dosed daily and sampled for 2 profiles, starting day 1 and day 14. A full profile was obtained from the subject on both occasions and analyzed for parent compound and 2 metabolites.
PC PP Cross-domain Example 2: PC
At a minimum, the nominal timing variables required for the analysis are PCNOMDY, PCTPTREF, and PCELTM; these timing variables have been populated, but PCDTC is null. PCRFTDTC is populated with only the date of dose as the time was not recorded in a manner readily available electronically. Although not crucial for the analysis, PCTPT was recorded and therefore populated in this example.
In this example, the sponsor chose to populate PCTPTNUM with a simple sequential sorting order; therefore, no timing information can be assumed from the data represented in this variable.
In the case of duration dosing (e.g., continuous infusion), all records can only have 1 reference time point; this must be consistent (i.e., always work from the start of the dose, or always work from the end of dose). If the end of dosing is used as the reference time point, then start time point = -PT1H for 1 hour infusion and immediate postdose would be PT0H.
The example shows the best practice of using PCCAT to differentiate in the dataset between the parent and metabolite. It also shows the best practice of populating PCNAM.
pc.xpt
Row | STUDYID | DOMAIN | USUBJID | PCSEQ | PCTESTCD | PCTEST | PCCAT | PCORRES | PCORRESU | PCSTRESC | PCSTRESN | PCSTRESU | PCSTAT | PCREASND | PCNAM | PCSPEC | PCBLFL | PCLLOQ | PCEXCLFL | PCREASEX | PCNOMDY | PCDTC | PCTPT | PCTPTNUM | PCELTM | PCTPTREF | PCRFTDTC |
1 | 5311016 | PC | 5311016- 101 | 1 | A9876543 | ABC9876543 | PARENT | 3000 | ng/mL | 3000 | 3000 | ng/mL | ACME INC | PLASMA | 1 | 1 | 0H30MIN | 1 | PT30M | Day 1 dose | 2018-01-01 | ||||||
2 | 5311016 | PC | 5311016- 101 | 3 | A9876543 | ABC9876543 | PARENT | 6240 | ng/mL | 6240 | 6240 | ng/mL | ACME INC | PLASMA | 1 | 1 | 1H | 2 | PT1H | Day 1 dose | 2018-01-01 | ||||||
3 | 5311016 | PC | 5311016- 101 | 5 | A9876543 | ABC9876543 | PARENT | 6950 | ng/mL | 6950 | 6950 | ng/mL | ACME INC | PLASMA | 1 | 1 | 2H | 3 | PT2H | Day 1 dose | 2018-01-01 | ||||||
4 | 5311016 | PC | 5311016- 101 | 7 | A9876543 | ABC9876543 | PARENT | 3630 | ng/mL | 3630 | 3630 | ng/mL | ACME INC | PLASMA | 1 | 1 | 4H | 4 | PT4H | Day 1 dose | 2018-01-01 | ||||||
5 | 5311016 | PC | 5311016- 101 | 9 | A9876543 | ABC9876543 | PARENT | ng/mL | ng/mL | NOT DONE | MISSING SAMPLE | ACME INC | PLASMA | 1 | 1 | 8H | 5 | PT8H | Day 1 dose | 2018-01-01 | |||||||
6 | 5311016 | PC | 5311016- 101 | 11 | A9876543 | ABC9876543 | PARENT | 27 | ng/mL | 27 | 27 | ng/mL | ACME INC | PLASMA | 1 | 1 | 24H | 6 | PT24H | Day 1 dose | 2018-01-01 | ||||||
7 | 5311016 | PC | 5311016- 101 | 2 | A9871234 | ABC9871234 | METABOLITE | 6680 | ng/mL | 6680 | 6680 | ng/mL | ACME INC | PLASMA | 1 | 1 | 0H30MIN | 1 | PT30M | Day 1 dose | 2018-01-01 | ||||||
8 | 5311016 | PC | 5311016- 101 | 4 | A9871234 | ABC9871234 | METABOLITE | 11700 | ng/mL | 11700 | 11700 | ng/mL | ACME INC | PLASMA | 1 | 1 | 1H | 2 | PT1H | Day 1 dose | 2018-01-01 | ||||||
9 | 5311016 | PC | 5311016- 101 | 6 | A9871234 | ABC9871234 | METABOLITE | 14200 | ng/mL | 14200 | 14200 | ng/mL | ACME INC | PLASMA | 1 | 1 | 2H | 3 | PT2H | Day 1 dose | 2018-01-01 |
Row | STUDYID | DOMAIN | USUBJID | PCSEQ | PCTESTCD | PCTEST | PCCAT | PCORRES | PCORRESU | PCSTRESC | PCSTRESN | PCSTRESU | PCSTAT | PCREASND | PCNAM | PCSPEC | PCBLFL | PCLLOQ | PCEXCLFL | PCREASEX | PCNOMDY | PCDTC | PCTPT | PCTPTNUM | PCELTM | PCTPTREF | PCRFTDTC |
10 | 5311016 | PC | 5311016- 101 | 8 | A9871234 | ABC9871234 | METABOLITE | 13900 | ng/mL | 13900 | 13900 | ng/mL | ACME INC | PLASMA | 1 | 1 | 4H | 4 | PT4H | Day 1 dose | 2018-01-01 | ||||||
11 | 5311016 | PC | 5311016- 101 | 10 | A9871234 | ABC9871234 | METABOLITE | ng/mL | ng/mL | NOT DONE | MISSING SAMPLE | ACME INC | PLASMA | 1 | 1 | 8H | 5 | PT8H | Day 1 dose | 2018-01-01 | |||||||
12 | 5311016 | PC | 5311016- 101 | 12 | A9871234 | ABC9871234 | METABOLITE | 90.1 | ng/mL | 90.1 | 90.1 | ng/mL | ACME INC | PLASMA | 1 | 1 | 24H | 6 | PT24H | Day 1 dose | 2018-01-01 | ||||||
13 | 5311016 | PC | 5311016- 101 | 13 | A9876543 | ABC9876543 | PARENT | <1 | ng/mL | BLQ | ng/mL | ACME INC | PLASMA | 1 | 14 | PREDOSE | 1 | PT0H | Day 14 dose | 2018-01-14 | |||||||
14 | 5311016 | PC | 5311016- 101 | 15 | A9876543 | ABC9876543 | PARENT | 2970 | ng/mL | 2970 | 2970 | ng/mL | ACME INC | PLASMA | 1 | 14 | 0H30MIN | 2 | PT30M | Day 14 dose | 2018-01-14 | ||||||
15 | 5311016 | PC | 5311016- 101 | 17 | A9876543 | ABC9876543 | PARENT | 6270 | ng/mL | 6270 | 6270 | ng/mL | ACME INC | PLASMA | 1 | 14 | 1H | 3 | PT1H | Day 14 dose | 2018-01-14 | ||||||
16 | 5311016 | PC | 5311016- 101 | 19 | A9876543 | ABC9876543 | PARENT | 6290 | ng/mL | 6290 | 6290 | ng/mL | ACME INC | PLASMA | 1 | 14 | 2H | 4 | PT2H | Day 14 dose | 2018-01-14 | ||||||
17 | 5311016 | PC | 5311016- 101 | 21 | A9876543 | ABC9876543 | PARENT | 3170 | ng/mL | 3170 | 3170 | ng/mL | ACME INC | PLASMA | 1 | 14 | 4H | 5 | PT4H | Day 14 dose | 2018-01-14 | ||||||
18 | 5311016 | PC | 5311016- 101 | 23 | A9876543 | ABC9876543 | PARENT | 1550 | ng/mL | 1550 | 1550 | ng/mL | ACME INC | PLASMA | 1 | 14 | 8H | 6 | PT8H | Day 14 dose | 2018-01-14 | ||||||
19 | 5311016 | PC | 5311016- 101 | 25 | A9876543 | ABC9876543 | PARENT | 49.5 | ng/mL | 49.5 | 49.5 | ng/mL | ACME INC | PLASMA | 1 | 14 | 24H | 7 | PT24H | Day 14 dose | 2018-01-14 | ||||||
20 | 5311016 | PC | 5311016- 101 | 14 | A9871234 | ABC9871234 | METABOLITE | <1 | ng/mL | BLQ | ng/mL | ACME INC | PLASMA | 1 | 14 | PREDOSE | 1 | PT0H | Day 14 dose | 2018-01-14 | |||||||
21 | 5311016 | PC | 5311016- 101 | 16 | A9871234 | ABC9871234 | METABOLITE | 3350 | ng/mL | 3350 | 3350 | ng/mL | ACME INC | PLASMA | 1 | 14 | 0H30MIN | 2 | PT30M | Day 14 dose | 2018-01-14 | ||||||
22 | 5311016 | PC | 5311016- 101 | 18 | A9871234 | ABC9871234 | METABOLITE | 8370 | ng/mL | 8370 | 8370 | ng/mL | ACME INC | PLASMA | 1 | 14 | 1H | 3 | PT1H | Day 14 dose | 2018-01-14 | ||||||
23 | 5311016 | PC | 5311016- 101 | 20 | A9871234 | ABC9871234 | METABOLITE | 14800 | ng/mL | 14800 | 14800 | ng/mL | ACME INC | PLASMA | 1 | 14 | 2H | 4 | PT2H | Day 14 dose | 2018-01-14 | ||||||
24 | 5311016 | PC | 5311016- 101 | 22 | A9871234 | ABC9871234 | METABOLITE | 11900 | ng/mL | 11900 | 11900 | ng/mL | ACME INC | PLASMA | 1 | 14 | 4H | 5 | PT4H | Day 14 dose | 2018-01-14 | ||||||
25 | 5311016 | PC | 5311016- 101 | 24 | A9871234 | ABC9871234 | METABOLITE | 8610 | ng/mL | 8610 | 8610 | ng/mL | ACME INC | PLASMA | 1 | 14 | 8H | 6 | PT8H | Day 14 dose | 2018-01-14 | ||||||
26 | 5311016 | PC | 5311016- 101 | 26 | A9871234 | ABC9871234 | METABOLITE | 124 | ng/mL | 124 | 124 | ng/mL | ACME INC | PLASMA | 1 | Y | Concentration result excluded due to hemolysis | 14 | 24H | 7 | PT24H | Day 14 dose | 2018-01-14 |
PC PP Cross-domain Example 2: PP
This example shows how PPTPTREF relates back to the PCTPTREF in the PC domain.
For the dose date/time, the date is known, but not the exact time; therefore, PPRFTDTC is populated with the data portion only.
pp.xpt
Row | STUDYID | DOMAIN | USUBJID | PPSEQ | PPTESTCD | PPTEST | PPCAT | PPSCAT | PPORRES | PPORRESU | PPSTRESC | PPSTRESN | PPSTRESU | PPSPEC | PPNOMDY | PPTPTREF | PPRFTDTC | PPSTINT | PPENINT |
1 | 5311016 | PP | 5311016-101 | 1 | AUCINT | AUC from T1 to T2 | ABC9876543 | PARENT | 56805 | h*ng/mL | 56805 | 56805 | h*ng/mL | PLASMA | 1 | Day 1 dose | 2018-01-01 | PT0H | PT24H |
2 | 5311016 | PP | 5311016-101 | 2 | CMAX | Max Conc | ABC9876543 | PARENT | 6950 | ng/mL | 6950 | 6950 | ng/mL | PLASMA | 1 | Day 1 dose | 2018-01-01 | ||
3 | 5311016 | PP | 5311016-101 | 3 | TMAX | Max Conc | ABC9876543 | PARENT | 2 | h | 2 | 2 | h | PLASMA | 1 | Day 1 dose | 2018-01-01 | ||
4 | 5311016 | PP | 5311016-101 | 4 | AUCINTD | AUC from T1 to T2 Norm by Dose | ABC9876543 | PARENT | 5681 | h*ng/mL/(mg/kg) | 5681 | 5681 | h*ng/mL/(mg/kg) | PLASMA | 1 | Day 1 dose | 2018-01-01 | PT0H | PT24H |
5 | 5311016 | PP | 5311016-101 | 5 | CMAXD | Max Conc Norm by Dose | ABC9876543 | PARENT | 695 | ng/mL/(mg/kg) | 695 | 695 | ng/mL/(mg/kg) | PLASMA | 1 | Day 1 dose | 2018-01-01 | ||
6 | 5311016 | PP | 5311016-101 | 6 | AUCINT | AUC from T1 to T2 | ABC9876543 | PARENT | 41029 | h*ng/mL | 41029 | 41029 | h*ng/mL | PLASMA | 14 | Day 14 dose | 2018-01-01 | PT0H | PT24H |
7 | 5311016 | PP | 5311016-101 | 7 | CMAX | Max Conc | ABC9876543 | PARENT | 6290 | ng/mL | 6290 | 6290 | ng/mL | PLASMA | 14 | Day 14 dose | 2018-01-01 | ||
8 | 5311016 | PP | 5311016-101 | 8 | TMAX | Time of CMAX | ABC9876543 | PARENT | 2 | h | 2 | 2 | h | PLASMA | 14 | Day 14 dose | 2018-01-01 |
Row | STUDYID | DOMAIN | USUBJID | PPSEQ | PPTESTCD | PPTEST | PPCAT | PPSCAT | PPORRES | PPORRESU | PPSTRESC | PPSTRESN | PPSTRESU | PPSPEC | PPNOMDY | PPTPTREF | PPRFTDTC | PPSTINT | PPENINT |
9 | 5311016 | PP | 5311016-101 | 9 | AUCINTD | AUC from T1 to T2 Norm by Dose | ABC9876543 | PARENT | 4103 | h*ng/mL/(mg/kg) | 4103 | 4103 | h*ng/mL/(mg/kg) | PLASMA | 14 | Day 14 dose | 2018-01-01 | PT0H | PT24H |
10 | 5311016 | PP | 5311016-101 | 10 | CMAXD | Max Conc Norm by Dose | ABC9876543 | PARENT | 629 | ng/mL/(mg/kg) | 629 | 629 | ng/mL/(mg/kg) | PLASMA | 14 | Day 14 dose | 2018-01-01 | ||
11 | 5311016 | PP | 5311016-101 | 11 | AUCINT | AUC from T1 to T2 | ABC9871234 | METABOLITE | 187216 | h*ng/mL | 187216 | 187216 | h*ng/mL | PLASMA | 1 | Day 1 dose | 2018-01-01 | PT0H | PT24H |
12 | 5311016 | PP | 5311016-101 | 12 | CMAX | Max Conc | ABC9871234 | METABOLITE | 14200 | ng/mL | 14200 | 14200 | ng/mL | PLASMA | 1 | Day 1 dose | 2018-01-01 | ||
13 | 5311016 | PP | 5311016-101 | 13 | TMAX | Time of CMAX | ABC9871234 | METABOLITE | 2 | h | 2 | 2 | h | PLASMA | 1 | Day 1 dose | 2018-01-14 | ||
14 | 5311016 | PP | 5311016-101 | 14 | AUCINTD | AUC from T1 to T2 Norm by Dose | ABC9871234 | METABOLITE | 18722 | h*ng/mL/(mg/kg) | 18722 | 18722 | h*ng/mL/(mg/kg) | PLASMA | 1 | Day 1 dose | 2018-01-14 | PT0H | PT24H |
15 | 5311016 | PP | 5311016-101 | 15 | CMAXD | Max Conc Norm by Dose | ABC9871234 | METABOLITE | 1420 | ng/mL/(mg/kg) | 1420 | 1420 | ng/mL/(mg/kg) | PLASMA | 1 | Day 1 dose | 2018-01-14 | ||
16 | 5311016 | PP | 5311016-101 | 16 | AUCINT | AUC from T1 to T2 | ABC9871234 | METABOLITE | 152945 | h*ng/mL | 152945 | 152945 | h*ng/mL | PLASMA | 14 | Day 14 dose | 2018-01-14 | PT0H | PT24H |
17 | 5311016 | PP | 5311016-101 | 17 | CMAX | Max Conc | ABC9871234 | METABOLITE | 14800 | ng/mL | 14800 | 14800 | ng/mL | PLASMA | 14 | Day 14 dose | 2018-01-14 | ||
18 | 5311016 | PP | 5311016-101 | 18 | TMAX | Time of CMAX | ABC9871234 | METABOLITE | 2 | h | 2 | 2 | h | PLASMA | 14 | Day 14 dose | 2018-01-14 | ||
19 | 5311016 | PP | 5311016-101 | 19 | AUCINTD | AUC from T1 to T2 Norm by Dose | ABC9871234 | METABOLITE | 15295 | h*ng/mL/(mg/kg) | 15295 | 15295 | h*ng/mL/(mg/kg) | PLASMA | 14 | Day 14 dose | 2018-01-14 | PT0H | PT24H |
20 | 5311016 | PP | 5311016-101 | 20 | CMAXD | Max Conc Norm by Dose | ABC9871234 | METABOLITE | 1480 | ng/mL/(mg/kg) | 1480 | 1480 | ng/mL/(mg/kg) | PLASMA | 14 | Day 14 dose | 2018-01-14 |
PC PP Cross-domain Example 2: SUPPPC
This example shows a SUPPPC domain to specify the PCCALCN value used for the PC records where the result fell below the limit of quantitation.
supppc.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
1 | 5311016 | PC | 5311016-101 | PCSTRESC | BLQ | PCCALCN | Numeric Interpretation for Calculations | 0 | DERIVED |
PC PP Cross-domain Example 3
This cross-domain example shows a PC domain for a rodent sparse sampling study of 9 animal subjects, where all timing information was readily available electronically. The subjects were dosed daily and sampled to construct 2 time-concentration profiles, with one referencing the day 1 dose and the other referencing the day 42 dose. The concentration data were then combined by reference dose (day 1 or day 42) to create composite rat exposures in the PP domain.
PC PP Cross-domain Example 3: PC
PCCAT and PCSCAT are not populated because there is only 1 value within PCTEST/PCTESTCD.
PCTPTNUM is intended to aid in sorting. In this example, it is populated with the chronological value of time in minutes between the PCTPT and PCTPTREF, even though PCELTM represents the equivalent time in hours.
This example shows a well constructed, informative PCTPT and PCTPTREF.
pc.xpt
Row | STUDYID | DOMAIN | USUBJID | PCSEQ | PCTESTCD | PCTEST | PCCAT | PCSCAT | PCORRES | PCORRESU | PCSTRESC | PCSTRESN | PCSTRESU | PCNAM | PCSPEC | PCMETHOD | PCBLFL | PCLLOQ | PCNOMDY | PCDTC | PCDY | PCTPT | PCTPTNUM | PCELTM | PCTPTREF | PCRFTDTC |
1 | ABC-123 | PC | ABC-123- 2001 | 1 | LMN123 | LMN- 123 | 0.856 | ug/mL | 0.856 | 0.856 | ug/mL | LAB X | PLASMA | HPLC/MS/MS | 0.2 | 42 | 2015-05- 10T09:10:45 | 42 | Predose | 0 | PT0H | Day 42 Dose | 2015-05- 10T09:55:16 | |||
2 | ABC-123 | PC | ABC-123- 2001 | 2 | LMN123 | LMN- 123 | 28.9 | ug/mL | 28.9 | 28.9 | ug/mL | LAB X | PLASMA | HPLC/MS/MS | 0.2 | 42 | 2015-05- 10T11:56:02 | 42 | 2 hour postdose | 120 | PT2H | Day 42 Dose | 2015-05- 10T09:55:16 | |||
3 | ABC-123 | PC | ABC-123- 2001 | 3 | LMN123 | LMN- 123 | 0.559 | ug/mL | 0.559 | 0.559 | ug/mL | LAB X | PLASMA | HPLC/MS/MS | 0.2 | 42 | 2015-05- 11T09:55:28 | 43 | 24 hour postdose | 1440 | PT24H | Day 42 Dose | 2015-05- 10T09:55:16 | |||
4 | ABC-123 | PC | ABC-123- 2002 | 1 | LMN123 | LMN- 123 | 1.76 | ug/mL | 1.76 | 1.76 | ug/mL | LAB X | PLASMA | HPLC/MS/MS | 0.2 | 42 | 2015-05- 10T09:11:49 | 42 | Predose | 0 | PT0H | Day 42 Dose | 2015-05- 10T09:56:06 |
Row | STUDYID | DOMAIN | USUBJID | PCSEQ | PCTESTCD | PCTEST | PCCAT | PCSCAT | PCORRES | PCORRESU | PCSTRESC | PCSTRESN | PCSTRESU | PCNAM | PCSPEC | PCMETHOD | PCBLFL | PCLLOQ | PCNOMDY | PCDTC | PCDY | PCTPT | PCTPTNUM | PCELTM | PCTPTREF | PCRFTDTC |
5 | ABC-123 | PC | ABC-123- 2002 | 2 | LMN123 | LMN- 123 | 39 | ug/mL | 39 | 39 | ug/mL | LAB X | PLASMA | HPLC/MS/MS | 0.2 | 42 | 2015-05- 10T11:57:02 | 42 | 2 hour postdose | 120 | PT2H | Day 42 Dose | 2015-05- 10T09:56:06 | |||
6 | ABC-123 | PC | ABC-123- 2002 | 3 | LMN123 | LMN- 123 | 2.89 | ug/mL | 2.89 | 2.89 | ug/mL | LAB X | PLASMA | HPLC/MS/MS | 0.2 | 42 | 2015-05- 11T09:56:26 | 43 | 24 hour postdose | 1440 | PT24H | Day 42 Dose | 2015-05- 10T09:56:06 | |||
7 | ABC-123 | PC | ABC-123- 2003 | 1 | LMN123 | LMN- 123 | 0.646 | ug/mL | 0.646 | 0.646 | ug/mL | LAB X | PLASMA | HPLC/MS/MS | 0.2 | 42 | 2015-05- 10T09:12:53 | 42 | Predose | 0 | PT0H | Day 42 Dose | 2015-05- 10T09:57:07 | |||
8 | ABC-123 | PC | ABC-123- 2003 | 2 | LMN123 | LMN- 123 | 33.9 | ug/mL | 33.9 | 33.9 | ug/mL | LAB X | PLASMA | HPLC/MS/MS | 0.2 | 42 | 2015-05- 10T11:58:04 | 42 | 2 hour postdose | 120 | PT2H | Day 42 Dose | 2015-05- 10T09:57:07 | |||
9 | ABC-123 | PC | ABC-123- 2003 | 3 | LMN123 | LMN- 123 | 0.39 | ug/mL | 0.39 | 0.39 | ug/mL | LAB X | PLASMA | HPLC/MS/MS | 0.2 | 42 | 2015-05- 11T09:57:50 | 43 | 24 hour postdose | 1440 | PT24H | Day 42 Dose | 2015-05- 10T09:57:07 | |||
10 | ABC-123 | PC | ABC-123- 2004 | 1 | LMN123 | LMN- 123 | 18.9 | ug/mL | 18.9 | 18.9 | ug/mL | LAB X | PLASMA | HPLC/MS/MS | 0.2 | 42 | 2015-05- 10T09:45:21 | 42 | 0.25 hour postdose | 15 | PT0.25H | Day 42 Dose | 2015-05- 10T09:30:08 | |||
11 | ABC-123 | PC | ABC-123- 2004 | 2 | LMN123 | LMN- 123 | 16.1 | ug/mL | 16.1 | 16.1 | ug/mL | LAB X | PLASMA | HPLC/MS/MS | 0.2 | 42 | 2015-05- 10T13:30:50 | 42 | 4 hour postdose | 240 | PT4H | Day 42 Dose | 2015-05- 10T09:30:08 | |||
12 | ABC-123 | PC | ABC-123- 2004 | 3 | LMN123 | LMN- 123 | 1.28 | ug/mL | 1.28 | 1.28 | ug/mL | LAB X | PLASMA | HPLC/MS/MS | 0.2 | 42 | 2015-05- 12T09:30:17 | 44 | 48 hour postdose | 2880 | PT48H | Day 42 Dose | 2015-05- 10T09:30:08 | |||
13 | ABC-123 | PC | ABC-123- 2005 | 1 | LMN123 | LMN- 123 | 20.8 | ug/mL | 20.8 | 20.8 | ug/mL | LAB X | PLASMA | HPLC/MS/MS | 0.2 | 42 | 2015-05- 10T09:46:10 | 42 | 0.25 hour postdose | 15 | PT0.25H | Day 42 Dose | 2015-05- 10T09:31:07 | |||
14 | ABC-123 | PC | ABC-123- 2005 | 2 | LMN123 | LMN- 123 | 18 | ug/mL | 18 | 18 | ug/mL | LAB X | PLASMA | HPLC/MS/MS | 0.2 | 42 | 2015-05- 10T13:32:04 | 42 | 4 hour postdose | 240 | PT4H | Day 42 Dose | 2015-05- 10T09:31:07 | |||
15 | ABC-123 | PC | ABC-123- 2005 | 3 | LMN123 | LMN- 123 | 17.8 | ug/mL | 17.8 | 17.8 | ug/mL | LAB X | PLASMA | HPLC/MS/MS | 0.2 | 42 | 2015-05- 12T09:31:42 | 44 | 48 hour postdose | 2880 | PT48H | Day 42 Dose | 2015-05- 10T09:31:07 | |||
16 | ABC-123 | PC | ABC-123- 2006 | 1 | LMN123 | LMN- 123 | 23.9 | ug/mL | 23.9 | 23.9 | ug/mL | LAB X | PLASMA | HPLC/MS/MS | 0.2 | 42 | 2015-05- 10T09:47:10 | 42 | 0.25 hour postdose | 15 | PT0.25H | Day 42 Dose | 2015-05- 10T09:32:07 | |||
17 | ABC-123 | PC | ABC-123- 2006 | 2 | LMN123 | LMN- 123 | 22.4 | ug/mL | 22.4 | 22.4 | ug/mL | LAB X | PLASMA | HPLC/MS/MS | 0.2 | 42 | 2015-05- 10T13:33:22 | 42 | 4 hour postdose | 240 | PT4H | Day 42 Dose | 2015-05- 10T09:32:07 | |||
18 | ABC-123 | PC | ABC-123- 2006 | 3 | LMN123 | LMN- 123 | 0.520 | ug/mL | 0.520 | 0.520 | ug/mL | LAB X | PLASMA | HPLC/MS/MS | 0.2 | 42 | 2015-05- 12T09:32:56 | 44 | 48 hour postdose | 2880 | PT48H | Day 42 Dose | 2015-05- 10T09:32:07 | |||
19 | ABC-123 | PC | ABC-123- 2007 | 1 | LMN123 | LMN- 123 | 46.9 | ug/mL | 46.9 | 46.9 | ug/mL | LAB X | PLASMA | HPLC/MS/MS | 0.2 | 42 | 2015-05- 10T10:30:02 | 42 | 1 hour postdose | 60 | PT1H | Day 42 Dose | 2015-05- 10T09:30:23 | |||
20 | ABC-123 | PC | ABC-123- 2007 | 2 | LMN123 | LMN- 123 | 3.45 | ug/mL | 3.45 | 3.45 | ug/mL | LAB X | PLASMA | HPLC/MS/MS | 0.2 | 42 | 2015-05- 10T17:25:17 | 42 | 8 hour postdose | 480 | PT8H | Day 42 Dose | 2015-05- 10T09:30:23 | |||
21 | ABC-123 | PC | ABC-123- 2007 | 3 | LMN123 | LMN- 123 | BLQ (<0.200) | ug/mL | BLQ | ug/mL | LAB X | PLASMA | HPLC/MS/MS | 0.2 | 42 | 2015-05- 14T09:32:45 | 46 | 96 hour postdose | 5760 | PT96H | Day 42 Dose | 2015-05- 10T09:30:23 | ||||
22 | ABC-123 | PC | ABC-123- 2008 | 1 | LMN123 | LMN- 123 | 39.4 | ug/mL | 39.4 | 39.4 | ug/mL | LAB X | PLASMA | HPLC/MS/MS | 0.2 | 42 | 2015-05- 10T10:31:05 | 42 | 1 hour postdose | 60 | PT1H | Day 42 Dose | 2015-05- 10T09:31:26 | |||
23 | ABC-123 | PC | ABC-123- 2008 | 2 | LMN123 | LMN- 123 | 4.44 | ug/mL | 4.44 | 4.44 | ug/mL | LAB X | PLASMA | HPLC/MS/MS | 0.2 | 42 | 2015-05- 10T17:26:16 | 42 | 8 hour postdose | 480 | PT8H | Day 42 Dose | 2015-05- 10T09:31:26 | |||
24 | ABC-123 | PC | ABC-123- 2008 | 3 | LMN123 | LMN- 123 | BLQ (<0.200) | ug/mL | BLQ | ug/mL | LAB X | PLASMA | HPLC/MS/MS | 0.2 | 42 | 2015-05- 14T09:33:54 | 46 | 96 hour postdose | 5760 | PT96H | Day 42 Dose | 2015-05- 10T09:31:26 | ||||
25 | ABC-123 | PC | ABC-123- 2009 | 1 | LMN123 | LMN- 123 | 45.1 | ug/mL | 45.1 | 45.1 | ug/mL | LAB X | PLASMA | HPLC/MS/MS | 0.2 | 42 | 2015-05- 10T10:32:22 | 42 | 1 hour postdose | 60 | PT1H | Day 42 Dose | 2015-05- 10T09:32:26 | |||
26 | ABC-123 | PC | ABC-123- 2009 | 2 | LMN123 | LMN- 123 | 3.16 | ug/mL | 3.16 | 3.16 | ug/mL | LAB X | PLASMA | HPLC/MS/MS | 0.2 | 42 | 2015-05- 10T17:27:41 | 42 | 8 hour postdose | 480 | PT8H | Day 42 Dose | 2015-05- 10T09:32:26 | |||
27 | ABC-123 | PC | ABC-123- 2009 | 3 | LMN123 | LMN- 123 | BLQ (<0.200) | ug/mL | BLQ | ug/mL | LAB X | PLASMA | HPLC/MS/MS | 0.2 | 42 | 2015-05- 14T09:35:07 | 46 | 96 hour postdose | 5760 | PT96H | Day 42 Dose | 2015-05- 10T09:32:26 |
PC PP Cross-domain Example 3: PP
PPRFTDTC can be null due to sparse sampling. Data can be grouped by PPNOMDY and PPTPTREF.
In sparse sampling scenarios where multiple subjects contribute to a toxicokinetic result, PC and PP records cannot be directly linked by the unique timestamp for the dosing event (i.e., where EXDTC = PCRFTDTC
= PPRFTDTC). In such cases, PPRFTDTC can be left null. In the event that all subjects in a pool have the same reference time point date, it would also be acceptable to populate PPRFTDTC with the date (no time) that corresponds to the description in PPTPTREF.
In this example, even though all subjects in the pool shared the same date as the reference time point for the profile, the sponsor chose to leave PPRFTDTC as null.
pp.xpt
Row | STUDYID | DOMAIN | USUBJID | POOLID | PPSEQ | PPTESTCD | PPTEST | PPCAT | PPORRES | PPORRESU | PPSTRESC | PPSTRESN | PPSTRESU | PPSTAT | PPREASND | PPSPEC | PPNOMDY | PPTPTREF | PPRFTDTC |
1 | ABC-123 | PP | PP-Group 2 | 1 | CMAX | Max Conc | LMN- 123 | 43.8 | ug/mL | 43.8 | 43.8 | ug/mL | PLASMA | 42 | Day 42 Dose | ||||
2 | ABC-123 | PP | PP-Group 2 | 2 | CMAXD | Max Conc Norm by Dose | LMN- 123 | 0.438 | ug/mL/(mg/kg) | 0.438 | 0.438 | ug/mL/(mg/kg) | PLASMA | 42 | Day 42 Dose | ||||
3 | ABC-123 | PP | PP-Group 2 | 3 | TMAX | Time of CMAX | LMN- 123 | 1 | h | 1 | 1 | h | PLASMA | 42 | Day 42 Dose | ||||
4 | ABC-123 | PP | PP-Group 2 | 4 | TLST | Time of Last Nonzero Conc | LMN- 123 | 48 | h | 48 | 48 | h | PLASMA | 42 | Day 42 Dose | ||||
5 | ABC-123 | PP | PP-Group 2 | 5 | AUCLST | AUC to Last Nonzero Conc | LMN- 123 | 297 | h*ug/mL | 297 | 297 | h*ug/mL | PLASMA | 42 | Day 42 Dose | ||||
6 | ABC-123 | PP | PP-Group 2 | 6 | AUCLSTD | AUC to Last Nonzero Conc Norm by Dose | LMN- 123 | 2.97 | h*ug/mL/(mg/kg) | 2.97 | 2.97 | h*ug/mL/(mg/kg) | PLASMA | 42 | Day 42 Dose | ||||
7 | ABC-123 | PP | PP-Group 2 | 7 | LAMZHL | Half-Life Lambda z | LMN- 123 | NOT DONE | Not reported due to insufficient plasma concentration data | PLASMA | 42 | Day 42 Dose |
PC PP Cross-domain Example 3: SUPPPC
This example shows a SUPPC domain to specify the PCCALCN value used for the PC records where the result fell below the limit of quantitation.
supppc.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
1 | ABC-123 | PC | ABC-123-2007 | PCSTRESC | BLQ | PCCALCN | Numeric Interpretation for Calculations | 0 | DERIVED |
2 | ABC-123 | PC | ABC-123-2008 | PCSTRESC | BLQ | PCCALCN | Numeric Interpretation for Calculations | 0 | DERIVED |
3 | ABC-123 | PC | ABC-123-2009 | PCSTRESC | BLQ | PCCALCN | Numeric Interpretation for Calculations | 0 | DERIVED |
Row | STUDYID | POOLID | USUBJID |
1 | ABC-123 | PP-Group 2 | ABC-123-2001 |
2 | ABC-123 | PP-Group 2 | ABC-123-2002 |
3 | ABC-123 | PP-Group 2 | ABC-123-2003 |
4 | ABC-123 | PP-Group 2 | ABC-123-2004 |
5 | ABC-123 | PP-Group 2 | ABC-123-2005 |
6 | ABC-123 | PP-Group 2 | ABC-123-2006 |
7 | ABC-123 | PP-Group 2 | ABC-123-2007 |
8 | ABC-123 | PP-Group 2 | ABC-123-2008 |
9 | ABC-123 | PP-Group 2 | ABC-123-2009 |
PC PP Cross-domain Example 3: POOLDEF This example shows how the subjects were pooled. pooldef.xpt
Subject Characteristics – SC
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
DOMAIN | Domain Abbreviation | Char | SC | Identifier | Two-character abbreviation for the domain. | Req |
USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across a study for all applications or submissions involving the product. | Req | |
SCSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | |
SCGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. This is not the treatment group number. | Perm | |
SCTESTCD | Subject Characteristic Short Name | Char | Topic | Short name of the measurement, test, or examination described in SCTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in SCTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). SCTESTCD cannot contain characters other than letters, numbers, or underscores. Some extensible controlled values are: SPLRNAM, SPLRLOC, HAIRCOLR. | Req | |
SCTEST | Subject Characteristic | Char | Synonym Qualifier | Long name for SCTESTCD. The value in SCTEST cannot be longer than 40 characters. Examples: Test Subject Supplier, Test Subject Supplier Site, and Hair Coat Color. | Req | |
SCORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the subject characteristic as originally received or collected. | Exp | |
SCORRESU | Unit of the Original Result | Char | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology (http://www.cdisc.org/terminology) list. | Perm |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
SCSTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from SCORRES in a standard format or standard units. SCSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in SCSTRESN. For example, if a test has results NONE, NEG, and NEGATIVE in SCORRES, these results effectively have the same meaning. In this case, they could be represented in standard format in SCSTRESC with a single term NEGATIVE. | Exp | |
SCSTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of SCSTRESC. SCSTRESN should store all numeric test results or findings. | Perm | |
SCSTRESU | Unit of the Standardized Result | Char | Variable Qualifier | Standardized unit used for SCSTRESC and SCSTRESN. | Perm | |
SCDTC | Date/Time of Collection | Char | ISO 8601 | Timing | Date/Time of collection of the subject characteristic information, in ISO 8601 format. | Perm |
SCDY | Study Day of Collection | Num | Timing | Study day of collection, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm |
Assumptions for Subject Characteristics (SC) Domain Model
Subject Characteristics consists of data that is collected once per subject (per test). SC contains data that is either not normally expected to change during the study or whose change is not of interest after the initial collection.
Sponsors should ensure that data considered for submission in SC (e.g., hair coat, physical markings) do not actually belong in another domain. It is up to the sponsor to determine whether such data have any information relevant to this domain.
The structure for SC is based on the Findings general observation class. It is an extension of the Demographics (DM) dataset. Any data that can be submitted in the DM variables should not be submitted in SC.
Example for Subject Characteristics (SC) Domain Model
Example 1
This example shows data that are collected once per subject and which do not fit into the DM domain; these can be represented in SC. For this study, the hair coat color and physical markings were collected.
sc.xpt
Row | STUDYID | DOMAIN | USUBJID | SCSEQ | SCTESTCD | SCTEST | SCORRES | SCSTRESC | SCDTC | SCDY |
1 | DOG1 | SC | DOG1-001 | 1 | HAIRCOLR | Hair Coat Color | Bluetick | Bluetick | 2008-01-19 | 1 |
2 | DOG1 | SC | DOG1-001 | 2 | PHYMARK | Physical Marking | Neutered | Neutered | 2008-01-19 | 1 |
3 | DOG1 | SC | DOG1-002 | 1 | HAIRCOLR | Hair Coat Color | Tri-Color | Tri-Color | 2008-01-19 | 1 |
4 | DOG1 | SC | DOG1-002 | 2 | PHYMARK | Physical Marking | Non-USDA Tattoo # | Non-USDA Tattoo # | 2008-01-19 | 1 |
5 | DOG1 | SC | DOG1-003 | 1 | HAIRCOLR | Hair Coat Color | Redtick | Redtick | 2008-01-19 | 1 |
6 | DOG1 | SC | DOG1-003 | 2 | PHYMARK | Physical Marking | Undershot Bite | Undershot Bite | 2008-01-19 | 1 |
Row | STUDYID | DOMAIN | USUBJID | SCSEQ | SCTESTCD | SCTEST | SCORRES | SCSTRESC | SCDTC | SCDY |
7 | DOG1 | SC | DOG1-004 | 1 | HAIRCOLR | Hair Coat Color | Orange/ White | Orange/ White | 2008-01-19 | 1 |
8 | DOG1 | SC | DOG1-004 | 2 | PHYMARK | Physical Marking | Tail Bobbed | Tail Bobbed | 2008-10-19 | 1 |
List of Tests for Subject Characteristics (SC) Domain Model
The following table lists example tests for the SC domain, including descriptions of usage and any controlled terminology codelists associated with their values.
SCTESTCD | SCTEST | Type | Controlled Terms, Codelist or Format | Notes |
HAIRCOLR | Hair Coat Color | Char | Used to designate the hair coat color of the animal | |
PHYMARK | Physical Marking | Char | Used to identify any physical markings present on the animal | |
ALTID | Alternate Identifier | Char | Used to record any alternate identifiers for the animal (e.g., a tattoo number which differs from the SUBJID) | |
USDANUM | USDA Number | Char | May be used when a USDA number has been assigned to the animal | |
SPLRNAM | Test Subject Supplier | Char | The name of the test subject supplier for this subject | |
SPLRLOC | Test Subject Supplier Site | Char | City, state, and country of the test subject supplier for this subject | |
FEEDREG | Feeding Regimen | Char | Describes the feeding regimen for this subject |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
DOMAIN | Domain Abbreviation | Char | TF | Identifier | Two-character abbreviation for the domain. | Req |
USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product within the submission | Req | |
TFSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | |
TFGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. This is not the treatment group number. | Perm | |
TFREFID | Specimen Identifier | Char | Identifier | Internal or external specimen identifier. Example: Specimen barcode number. | Perm | |
TFSPID | Mass Identifier | Char | Identifier | Mass identifier such as MASS 1 or MASS A. Used when the mass was discovered during the in-life phase or during pathology and was assigned a mass identifier. The mass identification should be unique within the subject, regardless of mass location. | Exp | |
TFTESTCD | Tumor Examination Short Name | Char | Topic | Short name of the measurement, test, or examination described in TFTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in TFTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not | Req |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
valid). TFTESTCD cannot contain characters other than letters, numbers, or underscores. Example: TUMEX. | ||||||
TFTEST | Tumor Examination Name | Char | Synonym Qualifier | Long name for TFTESTCD. The value in TFTEST cannot be longer than 40 characters. Example: Tumor Examination. | Req | |
TFORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the histopathological examination as originally received or collected. | Exp | |
TFSTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the tumor name mapped from TFORRES into a standard format from the controlled terms list. | Exp | |
TFRESCAT | Tumor Malignancy Status | Char | Variable Qualifier | Used to record the malignancy of the tumor as determined by the pathologist. It may be copied or derived from a description in TFORRES. Examples: BENIGN, MALIGNANT, METASTATIC, and UNDETERMINED. | Req | |
TFNAM | Laboratory Name | Char | Record Qualifier | Name or identifier of the laboratory or vendor that provided the test results. | Perm | |
TFSPEC | Specimen Material Type | Char | Record Qualifier | Defines the type of tissue, organ, or fluid specimen examined. Examples: LIVER, HEART. | Req | |
TFANTREG | Anatomical Region of Specimen | Char | Variable Qualifier | Defines the specific anatomical or biological region of a tissue, organ specimen, or the region from which the specimen was obtained, such as a section or part of what is defined in the TFSPEC variable. If the anatomical region is not included in the specimen description TFSPEC, it may be included in this variable. This field can be a combination of terms where needed. This field can be null if not applicable. Examples: CORTEX, MEDULLA, MUCOSA, SEROSA, ISLET, ZONA FASICULATA, ZONA RETICULARIS, CRANIAL, MEDIAN, ACCESSORY, SPINAL, LUMBAR, FRONTAL. | Perm | |
TFSPCCND | Specimen Condition | Char | Record Qualifier | Free or standardized text describing the condition of the specimen. Example: AUTOLYZED. | Perm | |
TFLAT | Specimen Laterality within Subject | Char | Variable Qualifier | Qualifier for laterality of the specimen within the subject for paired specimens. Examples: LEFT, RIGHT, BILATERAL. | Perm | |
TFDIR | Specimen Directionality within Subject | Char | Variable Qualifier | Qualifier for directionality of the specimen within the subject. Examples: DORSAL, PROXIMAL. | Perm | |
TFMETHOD | Method of Test or Examination | Char | Record Qualifier | Method of the test or examination. This could be different types of staining used for the slides. Example: H&E. | Perm | |
TFEVAL | Evaluator | Char | Record Qualifier | Role of the person who provided the evaluation. Example: TOX PATHOLOGIST, PEER REVIEW, SPONSOR PATHOLOGIST. | Perm | |
TFDTHREL | Relationship to Death | Char | Record Qualifier | Describes the relationship of a particular finding to the death of a subject. Example: Y if the tumor was the cause of death, N if the tumor was not the cause of death, or U for Unknown. Null cannot be used because the variable is required. | Req | |
TFDTC | Date/Time | Char | ISO 8601 | Timing | For a specimen collected or observed post mortem, this is the date/time of subject disposition, in ISO 8601 format. | Perm |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
TFDY | Study Day | Num | Timing | For a specimen collected or observed post mortem, this is the study day of subject disposition, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | |
TFDETECT | Time in Days to Detection of Tumor | Num | Timing | The number of days from the start of dosing to the earliest detection of the tumor in the experimental phase. This variable must be populated for every tumor discovered during the experimental phase. | Req |
Assumptions for Tumor Findings (TF) Domain Model
The TF domain captures the post-mortem tumor findings of the study. Records in this domain are a subset of records in the Microscopic Findings (MI) domain.
This domain is necessary if the SEND datasets are the basis for creation of the tumor.xpt dataset (as described in the FDA Study Data Technical Conformance Guide). See Appendix C, Mapping to Tumor xpt File.
One subject may have multiple records for any organ, if multiple tumors were found.
The TFDETECT variable is the number of days relative to the first day of treatment when the tumor was first detected. Depending on how the tumor was detected, this could be derived from CLDTC, PMDTC, or DSSTDTC.
If the tumor was detected as a clinical sign, then TFDETECT is based on the Clinical Observations (CL) domain start date/time of observation variable (CLDTC). This is calculated as (CLDTC – EXSTDTC) + 1.
If the tumor was detected as a palpable mass, then TFDETECT is based on the Palpable Masses (PM) domain start date/time of observation variable (PMDTC). This is calculated as (PMDTC – EXSTDTC) + 1.
If the tumor was initially detected during necropsy (the MA domain), then TFDETECT is based on the Disposition (DS) domain start date/time of observation variable (DSSTDTC). This is calculated as (DSSTDTC – EXSTDTC) + 1.
If the tumor was initially detected during histopathology examination (the MI domain), then TFDETECT is based off the DS domain variable DSSTDTC. This is calculated as (DSSTDTC – EXSTDTC) + 1.
The TFSPID variable is intended to reflect the mass identification. This variable should be used to link in-life findings with pathology findings. The mass identifier in --SPID should be consistent across domains (CL, PM, MA, MI, and TF).
Examples for Tumor Findings (TF) Domain Model
Example 1
This example shows some tumor findings for subject ABC-113.
tf.xpt
Row | STUDYID | DOMAIN | USUBJID | TFSEQ | TFGRPID | TFSPID | TFTESTCD | TFTEST | TFORRES | TFSTRESC | TFRESCAT | TFSPEC | TFANTREG | TFLAT | TFDTHREL | TFDETECT |
1 | ABC | TF | ABC-113 | 1 | MASS A | TUMEX | Tumor Examination | ACINAR CELL ADENOMA, PRIMARY | ADENOMA, ACINAR CELL, BENIGN | BENIGN | PANCREAS | N | 699 | |||
2 | ABC | TF | ABC-113 | 2 | 1 | MASS B | TUMEX | Tumor Examination | HISTIOCYTIC SARCOMA, PRIMARY | SARCOMA, HISTIOCYTIC, MALIGNANT | MALIGNANT | KIDNEY | LEFT | N | 699 | |
3 | ABC | TF | ABC-113 | 3 | MASS C | TUMEX | Tumor Examination | FIBROSARCOMA, PRIMARY | FIBROSARCOMA, MALIGNANT | MALIGNANT | SKIN | SUBCUTIS | U | 699 | ||
4 | ABC | TF | ABC-113 | 4 | 1 | MASS D | TUMEX | Tumor Examination | HISTIOCYTIC SARCOMA, SECONDARY | SARCOMA, HISTIOCYTIC, MALIGNANT | METASTATIC | OVARY | BILATERAL | N | 699 | |
5 | ABC | TF | ABC-113 | 5 | 2 | MASS E | TUMEX | Tumor Examination | LYMPHOMA, MALIGNANT, MULTICENTRIC | LYMPHOMA, MALIGNANT | METASTATIC | LIVER | PORTAL TRIAD | Y | 673 | |
6 | ABC | TF | ABC-113 | 6 | 2 | MASS F | TUMEX | Tumor Examination | LYMPHOMA, MALIGNANT, MULTICENTRIC | LYMPHOMA, MALIGNANT | METASTATIC | SPLEEN | Y | 673 | ||
7 | ABC | TF | ABC-113 | 7 | 2 | MASS G | TUMEX | Tumor Examination | LYMPHOMA, MALIGNANT, MULTICENTRIC | LYMPHOMA, MALIGNANT | MALIGNANT | SITE, UNCERTAIN PRIMARY | Y | 673 |
These rows show the supplemental qualifier records for the modifiers associated with the findings in Example 1.
supptf.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
1 | ABC | TF | ABC-113 | TFSEQ | 1 | TFRESMOD | Result Modifiers | PRIMARY | COLLECTED |
2 | ABC | TF | ABC-113 | TFSEQ | 2 | TFRESMOD | Result Modifiers | PRIMARY | COLLECTED |
3 | ABC | TF | ABC-113 | TFSEQ | 3 | TFRESMOD | Result Modifiers | PRIMARY | COLLECTED |
4 | ABC | TF | ABC-113 | TFSEQ | 4 | TFRESMOD | Result Modifiers | SECONDARY | COLLECTED |
5 | ABC | TF | ABC-113 | TFSEQ | 5 | TFRESMOD | Result Modifiers | MULTICENTRIC | COLLECTED |
6 | ABC | TF | ABC-113 | TFSEQ | 6 | TFRESMOD | Result Modifiers | MULTICENTRIC | COLLECTED |
7 | ABC | TF | ABC-113 | TFSEQ | 7 | TFRESMOD | Result Modifiers | MULTICENTRIC | COLLECTED |
Example 2
This example shows a single tumor finding for subject ABC-101 in a carcinogenicity study.This tumor was not the cause of death (TFDTHREL="N") and it was not discovered during the in-life phase, so TFDETECT is populated with death day. However, the finding relates to a necropsy finding of raised focus of the lung, so a RELREC record is created for this relationship.
tf.xpt
Row | STUDYID | DOMAIN | USUBJID | TFSEQ | TFSPID | TFTESTCD | TFTEST | TFORRES | TFSTRESC | TFRESCAT | TFSPEC | TFLAT | TFDTHREL | TFDETECT |
1 | ABC | TF | ABC-101 | 1 | MASS A | TUMEX | Tumor Examination | BRONCHIOLO- ALVEOLAR CARCINOMA | CARCINOMA, BRONCHIOLOALVEOLAR, MALIGNANT | MALIGNANT | LUNG | LEFT | N | 702 |
This RELREC example is included as part of the comment in row 1.
relrec.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
1 | ABC | TF | ABC-101 | TFSEQ | 1 | 1 | |
2 | ABC | MA | ABC-101 | MASEQ | 10 | 1 |
Example 3
This example shows a tumor finding for subject ABC-245.
This record shows a malignant (TFRESCAT) tumor that was the cause of death for the animal (TFDTHREL="Y"). In addition, this tumor was palpated during the experimental phase. It was determined that the earliest onset day for this tumor was study day 653 for this subject. This record is related to records in other domains as indicated by the RELREC example that follows.
tf.xpt
Row | STUDYID | DOMAIN | USUBJID | TFSEQ | TFSPID | TFTESTCD | TFTEST | TFORRES | TFSTRESC | TFRESCAT | TFSPEC | TFDTHREL | TFDETECT |
1 | ABC | TF | ABC-245 | 45 | MASS 4 | TUMEX | Tumor Examination | HISTIOCYTIC SARCOMA | SARCOMA, HISTIOCYTIC, MALIGNANT | MALIGNANT | BONE, FEMUR | Y | 653 |
This RELREC example is included as part of the comment in row 1.
relrec.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
1 | ABC | TF | ABC-245 | TFSPID | MASS 4 | 2 | |
2 | ABC | CL | ABC-245 | CLSPID | MASS 4 | 2 | |
3 | ABC | PM | ABC-245 | PMSPID | MASS 4 | 2 | |
4 | ABC | MI | ABC-245 | MISPID | MASS 4 | 2 | |
5 | ABC | MA | ABC-245 | MASPID | MASS 4 | 2 |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
DOMAIN | Domain Abbreviation | Char | VS | Identifier | Two-character abbreviation for the domain. | Req |
USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | |
VSSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | |
VSGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. This is not the treatment group number. | Perm | |
VSSPID | Sponsor-Defined Identifier | Char | Identifier | Sponsor-defined reference identifier | Perm | |
VSTESTCD | Vital Signs Test Short Name | Char | (SVSTSTCD) | Topic | Short name of the measurement described in VSTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in VSTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). VSTESTCD cannot contain characters other than letters, numbers, or underscores. | Req |
VSTEST | Vital Signs Test Name | Char | (SVSTST) | Synonym Qualifier | Long name for VSTESTCD. The value in VSTEST cannot be longer than 40 characters. | Req |
VSCAT | Category for Vital Signs | Char | Grouping Qualifier | Used to define a category of the vital signs measurement performed. | Perm | |
VSSCAT | Subcategory for Vital Signs | Char | Grouping Qualifier | A further categorization of the vital signs measurement performed. | Perm | |
VSPOS | Vital Signs Position of Subject | Char | Record Qualifier | Position of the subject during the measurement. If the subject is restrained, populate with the position (example SITTING or STANDING). | Perm |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
VSORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the vital signs measurement as originally received or collected. | Exp | |
VSORRESU | Unit of the Original Result | Char | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology (http://www.cdisc.org/terminology) list. | Exp | |
VSSTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from VSORRES in a standard format or standard units. VSSTRESC should store all results in character format; if results are numeric, they should also be submited in numeric format in VSSTRESN. | Exp | |
VSSTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of VSSTRESC. VSSTRESN should store all numeric test results or findings. | Exp | |
VSSTRESU | Unit of the Standardized Result | Char | Variable Qualifier | Standardized unit used for VSSTRESC and VSSTRESN. | Exp | |
VSSTAT | Completion Status | Char | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in VSORRES. | Perm | |
VSREASND | Reason Not Done | Char | Record Qualifier | Describes why VSSTAT is NOT DONE, such as BROKEN EQUIPMENT. | Perm | |
VSLOC | Location of Vital Signs Measurement | Char | Record Qualifier | Location relevant to the collection of the vital signs measurement. Example: RECTAL for Temperature. | Perm | |
VSCSTATE | Consciousness State | Char | Record Qualifier | Consciousness state of the subject at the time of measurement. Examples: CONSCIOUS, SEMI- CONSCIOUS, UNCONSCIOUS. | Perm | |
VSBLFL | Baseline Flag | Char | Record Qualifier | A baseline indicator may be used to calculate differences or changes from baseline. Value should be Y or null. The baseline flag is sponsor defined. | Exp | |
VSDRVFL | Derived Flag | Char | Record Qualifier | Used to indicate a derived record. The value should be Y or null. | Perm | |
VSEXCLFL | Exclusion Flag | Char | Record Qualifier | Y if the result should be excluded from all calculations, otherwise null. | Perm | |
VSREASEX | Reason for Exclusion | Char | Record Qualifier | The reason the result should be excluded from all calculations. Used only when VSEXCLFL is Y. | Perm | |
VSUSCHFL | Unscheduled Flag | Char | Record Qualifier | Indicates whether the timing of the performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null. | Perm | |
VISITDY | Planned Study Day of Collection | Num | Timing | Planned day of the vital signs measurement. Should be an integer. | Perm | |
VSDTC | Date/Time of Measurement | Char | ISO 8601 | Timing | Date/Time of the vital sign measurement, in ISO 8601 format. For indicating measurement over a period, DTC should be populated with the start date/time of collection. | Exp |
VSENDTC | End Date/Time of Measurement | Char | ISO 8601 | Timing | Date/Time of the end of the vital sign measurement, in ISO 8601 format. Should be populated for continuous period only. | Perm |
VSDY | Study Day of Vital Signs Measurement | Num | Timing | Study day of vital signs measurements, in integer days. For indicating measurement over a continuous period, VSDY can be used to indicate start day of that interval. The algorithm for | Perm |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | ||||||
VSENDY | Study Day of End of Measurement | Num | Timing | Study day of the end of the vital signs measurement, in integer days. Can be populated when VSDY represents the start day of a continuous evaluation interval. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | |
VSNOMDY | Nominal Study Day for Tabulations | Num | Timing | Nominal study day used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer. | Exp | |
VSNOMLBL | Label for Nominal Study Day | Char | Timing | A label for a given value of VSNOMDY as presented in the study report. Examples: Pre-Treatment, Week 4, Day 28. | Perm | |
VSTPT | Planned Time Point Name | Char | Timing | Text description of time when the vital signs measurement should be taken. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See VSTPTNUM and VSTPTREF. Examples: Predose, 1 Hour Postdose. | Perm | |
VSTPTNUM | Planned Time Point Number | Num | Timing | Numerical version of VSTPT to aid in sorting. | Perm | |
VSELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 | Timing | Planned elapsed time (in ISO 8601 format) relative to a planned fixed reference (VSTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as a duration in ISO 8601 format. Examples: '-PT15M' to represent the period of 15 minutes prior to the reference point indicated by VSTPTREF or 'PT8H' to represent the period of 8 hours after the reference point indicated by VSTPTREF. | Perm |
VSTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by VSELTM, if used for VSTPTNUM, and VSTPT. It is recommended that VSTPTREF be as descriptive as possible so the reference time point can be inferred without looking at other variables. Examples: DAY 1 DOSE, DAY 1 MEAL. | Perm | |
VSRFTDTC | Date/Time of Time Point Reference | Char | ISO 8601 | Timing | Date/Time of the reference time point, VSTPTREF. | Perm |
Assumptions for Vital Signs (VS) Domain Model
1. The VS domain is intended to hold vital signs measurements (e.g., body temperature) that are not otherwise covered in domains for respiratory and cardiovascular test data.
Examples for Vital Signs (VS) Domain Model
Example 1
This example shows vital signs collected for subject ABC-001-001.
vs.xpt
Row | STUDYID | DOMAIN | USUBJID | VSSEQ | VSTESTCD | VSTEST | VSORRES | VSORRESU | VSSTRESC | VSSTRESN | VSSTRESU | VSSTAT | VSREASND | VSLOC | VSBLFL | VSDTC | VSDY | VSNOMDY |
1 | ABC | VS | ABC-001-001 | 8 | TEMP | Temperature | 34.7 | C | 34.7 | 34.7 | C | RECTAL | 1999-06-19T08:45 | 1 | 1 | |||
2 | ABC | VS | ABC-001-001 | 9 | TEMP | Temperature | 36.2 | C | 36.2 | 36.2 | C | RECTAL | Y | 1999-06-19T09:00 | 1 | 1 | ||
3 | ABC | VS | ABC-001-001 | 14 | TEMP | Temperature | 97.2 | F | 36.2 | 36.2 | C | RECTAL | 1999-07-21T9:04 | 33 | 33 | |||
4 | ABC | VS | ABC-001-001 | 15 | TEMP | Temperature | NOT DONE | Equipment failure | 1999-07-31 | 43 | 43 |
Example 2
This example shows a collection of vital signs for subject ABC-001-001, where the time was not collected. The dosing regimen is once-weekly administration, which is why the first dose of the study (VSTPTREF) is on study day 1 (VSDY) and the second dose is on study day 8.
vs.xpt
Row | STUDYID | DOMAIN | USUBJID | VSSEQ | VSTESTCD | VSTEST | VSORRES | VSORRESU | VSSTRESC | VSSTRESN | VSSTRESU | VSBLFL | VSDTC | VSDY | VSNOMDY | VSTPT | VSTPTNUM | VSELTM | VSTPTREF |
1 | ABC | VS | ABC-001-001 | 1 | TEMP | Temperature | 34.7 | C | 34.7 | 34.7 | C | Y | 2012-10-25 | 1 | 1 | PREDOSE | 1 | PT0H | Day 1 Dose |
2 | ABC | VS | ABC-001-001 | 2 | TEMP | Temperature | 36.2 | C | 36.2 | 36.2 | C | 2012-10-25 | 1 | 1 | 30 MIN | 2 | PT0.5H | Day 1 Dose | |
3 | ABC | VS | ABC-001-001 | 3 | TEMP | Temperature | 37.1 | C | 37.1 | 37.1 | C | 2012-10-25 | 1 | 1 | 1H | 3 | PT1H | Day 1 Dose | |
4 | ABC | VS | ABC-001-001 | 4 | TEMP | Temperature | 34.3 | C | 34.3 | 34.3 | C | 2012-10-25 | 1 | 1 | 4H-6H | 4 | PT4H | Day 1 Dose | |
5 | ABC | VS | ABC-001-001 | 5 | TEMP | Temperature | 35.2 | C | 35.2 | 35.2 | C | 2012-11-01 | 8 | 8 | PREDOSE | 1 | PT0H | Day 2 Dose | |
6 | ABC | VS | ABC-001-001 | 6 | TEMP | Temperature | 35.9 | C | 35.9 | 35.9 | C | 2012-11-01 | 8 | 8 | 30 MIN | 2 | PT0.5H | Day 2 Dose | |
7 | ABC | VS | ABC-001-001 | 7 | TEMP | Temperature | 36.5 | C | 36.5 | 36.5 | C | 2012-11-01 | 8 | 8 | 1H | 3 | PT1H | Day 2 Dose | |
8 | ABC | VS | ABC-001-001 | 8 | TEMP | Temperature | 34.9 | C | 34.9 | 34.9 | C | 2012-11-01 | 8 | 8 | 4H-6H | 4 | PT4H | Day 2 Dose |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
DOMAIN | Domain Abbreviation | Char | EG | Identifier | Two-character abbreviation for the domain. | Req |
USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req | |
EGSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | |
EGGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. This is not the treatment group number. | Perm | |
EGREFID | ECG Reference Identifier | Char | Identifier | Internal or external ECG identifier. Example: UUID. | Perm | |
EGSPID | Sponsor-Defined Identifier | Char | Identifier | Sponsor-defined reference identifier. | Perm | |
EGTESTCD | ECG Test Short Name | Char | Topic | Short name of the measurement, test, or examination described in EGTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in EGTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). EGTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: EGHRMN, QTMAX. | Req | |
EGTEST | ECG Test Name | Char | Synonym Qualifier | Long name for EGTESTCD. The value in EGTEST cannot be longer than 40 characters. Examples: ECG Mean Heart Rate, Summary (Max) QT Duration. | Req | |
EGCAT | Category for ECG | Char | Grouping Qualifier | Used to define a category of the ECG test performed. Examples: MEASUREMENT, DIAGNOSIS, INTERPRETATION. | Perm | |
EGPOS | ECG Position of Subject | Char | Record Qualifier | Position of the subject during a measurement or examination. If the subject is restrained, populate with the position (example SITTING or STANDING); otherwise, populate with UNCONSTRAINED. | Exp | |
EGORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the ECG measurement or finding as originally received or collected. | Exp | |
EGORRESU | Unit of the Original Result | Char | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology (http://www.cdisc.org/terminology) list. | Exp | |
EGSTRESC | Standardized Result in Character Format | Char | (EGSTRESC) | Result Qualifier | Contains the result value for all findings, copied or derived from EGORRES, in a standard format or standard units. EGSTRESC should store all results or findings in character format, using controlled terminology, where possible. If results are numeric, they should also be stored in numeric format in EGSTRESN. | Exp |
EGSTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for numeric results or findings in standard format; contains the numeric form of EGSTRESC. EGSTRESN should store all numeric test results or findings. | Exp |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
EGSTRESU | Unit of the Standardized Result | Char | Variable Qualifier | Standardized unit used for EGSTRESC and EGSTRESN. | Exp | |
EGSTAT | Completion Status | Char | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in EGORRES. | Perm | |
EGREASND | Reason Not Done | Char | Record Qualifier | Describes why EGSTAT is NOT DONE, such as BROKEN EQUIPMENT. | Perm | |
EGXFN | ECG External File Name | Char | Record Qualifier | File name and path for the external ECG Waveform file. Would be used if sponsor is requested to submit waveform. | Perm | |
EGNAM | Laboratory Name | Char | Record Qualifier | Name or identifier of the laboratory or vendor that provided the test results. | Perm | |
EGMETHOD | Method of ECG Test | Char | Record Qualifier | Method of the test or examination. Examples: 12 LEAD STANDARD, 6 LEAD STANDARD. | Exp | |
EGLEAD | Lead Used for Measurement | Char | Record Qualifier | Lead identified to capture the measurement. | Exp | |
EGCSTATE | Consciousness State | Char | Record Qualifier | Consciousness state of the subject at the time of measurement. Examples: CONSCIOUS, SEMI- CONSCIOUS, UNCONSCIOUS. | Exp | |
EGBLFL | Baseline Flag | Char | Record Qualifier | A baseline indicator may be used to calculate differences or changes from baseline. Value should be Y or null. The baseline flag is sponsor defined. | Exp | |
EGDRVFL | Derived Flag | Char | Record Qualifier | Used to indicate a derived record. The value should be Y or null. Records that represent the average of other records, or that are not as originally received or collected, are examples of records that might be derived for the submission datasets. | Perm | |
EGEVAL | Evaluator | Char | Record Qualifier | Role of the person who provided the evaluation. Should be null for records that contain collected or derived data. Examples: RESPONSIBLE SCIENTIST, PRINCIPAL INVESTIGATOR, PEER REVIEWER. | Perm | |
EGEXCLFL | Exclusion Flag | Char | Record Qualifier | Y if the result should be excluded from all calculations, otherwise null. | Perm | |
EGREASEX | Reason for Exclusion | Char | Record Qualifier | The reason the result should be excluded from all calculations. Used only when EGEXCLFL is Y. | Perm | |
EGUSCHFL | Unscheduled Flag | Char | Record Qualifier | Indicates whether the timing of the performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null. | Perm | |
VISITDY | Planned Study Day of Collection | Num | Timing | Planned study day of collection. Should be an integer. | Perm | |
EGDTC | Date/Time of ECG Collection | Char | ISO 8601 | Timing | Date/Time of ECG data collection, in ISO 8601 format. For indicating measurement over a continuous period, DTC should be used to indicate start date/time of collection. | Exp |
EGENDTC | End Date/Time of ECG Collection | Char | ISO 8601 | Timing | Date/Time of end of the ECG data collection, in ISO 8601 format. Should be populated for measurement over a continuous period only. | Perm |
EGDY | Study Day of ECG Collection | Num | Timing | Study day of the ECG measurement collection, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
EGENDY | Study Day of End of ECG Collection | Num | Timing | Study day of the end of the ECG measurement collection, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | |
EGNOMDY | Nominal Study Day for Tabulations | Num | Timing | Nominal study day used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer. | Exp | |
EGNOMLBL | Label for Nominal Study Day | Char | Timing | A label for a given value of EGNOMDY as presented in the study report. Examples: Pre-Treatment, Week 4, Day 28. | Perm | |
EGTPT | Planned Time Point Name | Char | Timing | Text description of time when ECG data should be collected. Note: This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See EGTPTNUM and EGTPTREF. Examples: Predose, 1 Hour Postdose. | Perm | |
EGTPTNUM | Planned Time Point Number | Num | Timing | Numerical version of EGTPT to aid in sorting. | Perm | |
EGELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 | Timing | Planned elapsed time (in ISO 8601 format) relative to a fixed time point reference (EGTPTREF). This variable is useful where there are repetitive measures. Not a clock-time or a date-time variable. Represented as an ISO 8601 duration. Examples: "-PT15M" to represent the period of 15 minutes prior to the reference point indicated by EGTPTREF, or "PT8H" to represent the period of 8 hours after the reference point indicated by EGTPTREF. | Perm |
EGTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by EGELTM, if used for EGTPTNUM, and EGTPT. It is recommended that EGTPTREF be as descriptive as possible so the reference time point can be inferred without looking at others variables. Example: DAY 1 FIRST DOSE. | Perm | |
EGRFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 | Timing | Date/Time of the reference time point, EGTPTREF. | Perm |
EGEVLINT | Evaluation Interval | Char | ISO 8601 | Timing | Length of evaluation interval in ISO 8601 duration format. Used in place of EGSTINT and EGENINT when EGTPTREF is not available. | Perm |
EGSTINT | Planned Start of Assessment Interval | Char | ISO 8601 | Timing | Planned Start of an asessment interval relative to Time Point Reference (EGTPTREF) in ISO 8601 duration format. | Perm |
EGENINT | Planned End of Assessment Interval | Char | ISO 8601 | Timing | Planned End of an assessment interval relative to Time Point Reference (EGTPTREF) in ISO 8601 duration format. | Perm |
Assumptions for ECG Test Results (EG) Domain Model
The EG domain captures electrocardiographic (ECG)-specific parameters, as well as interpretations and diagnoses derived from those measurements.
The timing variables EGDTC, EGENDTC, EGDY and EGENDY are used to represent the actual start and end of the evaluation period during which data that contributed to the reported result were collected. This may be a portion of a longer period over which the instrument was continuously collecting data.
EGPOS, EGLEAD, EGMETHOD, and EGCSTATE are considered important for comparison purposes and should be populated whenever available or collected.
Examples for ECG Test Results (EG) Domain Model
The Cardiovascular Test Results (CV), EG, and Respiratory Test Results (RE) domains are very similar in structure. Note that the examples provided in this section represent uses of timing variables, which could apply to any of these domains, regardless of study type or design.
Example 1
This example contains ECG measurements during a repeat dose study. Results are for a discrete observation period with a target time point (e.g., 1 hour post-dose). The duration of the ECG recording could be based on a defined period of time (e.g., a cardiologist examining a 2-hour recording and selecting a segment of waveforms for analysis) or number of complexes (e.g., after 200 good complexes are recorded). As a result, EGSTINT and EGENINT are not populated, because the specific assessment interval is not planned.
eg.xpt
Row | STUDYID | DOMAIN | USUBJID | EGSEQ | EGTESTCD | EGTEST | EGPOS | EGORRES | EGORRESU | EGSTRESC | EGSTRESN | EGSTRESU | EGLEAD | EGMETHOD | EGCSTATE | EGBLFL | EGDTC | EGDY | EGNOMDY | EGTPT | EGTPTNUM | EGELTM | EGTPTREF | EGRFTDTC |
1 | TSA1397 | EG | 1 | 1 | EGHRMN | ECG Mean | SLING | 89 | beats/min | 89 | 89 | beats/min | LEAD II | 6 LEAD | CONSCIOUS | 2008-10- | -14 | -14 | Pretest | 1 | -P14D | Day 1 Dose | 2008-11- | |
Heart Rate | STANDARD | 28T07:46 | 11T08:54 | |||||||||||||||||||||
2 | TSA1397 | EG | 1 | 2 | EGHRMN | ECG Mean | SLING | 91 | beats/min | 91 | 91 | beats/min | LEAD II | 6 LEAD | CONSCIOUS | Y | 2008-12- | 23 | 23 | Predose | 2 | -PT5M | Day 23 | 2008-12- |
Heart Rate | STANDARD | 03T09:05 | Dose | 03T09:10 | ||||||||||||||||||||
3 | TSA1397 | EG | 1 | 3 | EGHRMN | ECG Mean | SLING | 116 | beats/min | 116 | 116 | beats/min | LEAD II | 6 LEAD | CONSCIOUS | 2008-12- | 23 | 23 | 2 Hour | 3 | PT120M | Day 23 | 2008-12- | |
Heart Rate | STANDARD | 03T11:03 | Postdose | Dose | 03T09:10 | |||||||||||||||||||
4 | TSA1397 | EG | 1 | 4 | QRSAG | QRS | SLING | 0.050 | sec | 50 | 50 | msec | LEAD II | 6 LEAD | CONSCIOUS | 2008-10- | -14 | -14 | Pretest | 1 | -P14D | Day 1 Dose | 2008-11- | |
Duration, | STANDARD | 28T07:46 | 11T08:54 | |||||||||||||||||||||
Aggregate | ||||||||||||||||||||||||
5 | TSA1397 | EG | 1 | 5 | QRSAG | QRS | SLING | 0.038 | sec | 38 | 38 | msec | LEAD II | 6 LEAD | CONSCIOUS | Y | 2008-12- | 23 | 23 | Predose | 2 | -PT5M | Day 23 | 2008-12- |
Duration, | STANDARD | 03T09:05 | Dose | 03T09:10 | ||||||||||||||||||||
Aggregate | ||||||||||||||||||||||||
6 | TSA1397 | EG | 1 | 6 | QRSAG | QRS | SLING | 0.039 | sec | 39 | 39 | msec | LEAD II | 6 LEAD | CONSCIOUS | 2008-12- | 23 | 23 | 2 Hour | 3 | PT120M | Day 23 | 2008-12- | |
Duration, | STANDARD | 03T11:03 | Postdose | Dose | 03T09:10 | |||||||||||||||||||
Aggregate | ||||||||||||||||||||||||
7 | TSA1397 | EG | 1 | 7 | PPAG | PP Interval, | SLING | 0.073 | sec | 73 | 73 | msec | LEAD II | 6 LEAD | CONSCIOUS | 2008-10- | -14 | -14 | Pretest | 1 | -P14D | Day 1 Dose | 2008-11- | |
Aggregate | STANDARD | 28T07:46 | 11T08:54 | |||||||||||||||||||||
8 | TSA1397 | EG | 1 | 8 | PPAG | PP Interval, | SLING | 0.083 | sec | 83 | 83 | msec | LEAD II | 6 LEAD | CONSCIOUS | Y | 2008-12- | 23 | 23 | Predose | 2 | -PT5M | Day 23 | 2008-12- |
Aggregate | STANDARD | 03T09:05 | Dose | 03T09:10 | ||||||||||||||||||||
9 | TSA1397 | EG | 1 | 9 | PPAG | PP Interval, | SLING | 0.076 | sec | 76 | 76 | msec | LEAD II | 6 LEAD | CONSCIOUS | 2008-12- | 23 | 23 | 2 Hour | 3 | PT120M | Day 23 | 2008-12- | |
Aggregate | STANDARD | 03T11:03 | Postdose | Dose | 03T09:10 | |||||||||||||||||||
10 | TSA1397 | EG | 1 | 10 | QTAG | QT Interval, | SLING | 0.209 | sec | 209 | 209 | msec | LEAD II | 6 LEAD | CONSCIOUS | 2008-10- | -14 | -14 | Pretest | 1 | -P14D | Day 1 Dose | 2008-11- | |
Aggregate | STANDARD | 28T07:46 | 11T08:54 | |||||||||||||||||||||
11 | TSA1397 | EG | 1 | 11 | QTAG | QT Interval, | SLING | 0.222 | sec | 222 | 222 | msec | LEAD II | 6 LEAD | CONSCIOUS | Y | 2008-12- | 23 | 23 | Predose | 2 | -PT5M | Day 23 | 2008-12- |
Aggregate | STANDARD | 03T09:05 | Dose | 03T09:10 | ||||||||||||||||||||
12 | TSA1397 | EG | 1 | 12 | QTAG | QT Interval, | SLING | 0.192 | sec | 192 | 192 | msec | LEAD II | 6 LEAD | CONSCIOUS | 2008-12- | 23 | 23 | 2 Hour | 3 | PT120M | Day 23 | 2008-12- | |
Aggregate | STANDARD | 03T11:03 | Postdose | Dose | 03T09:10 | |||||||||||||||||||
13 | TSA1397 | EG | 1 | 13 | QTCFAG | QTcF | SLING | 0.238 | sec | 238 | 238 | msec | LEAD II | 6 LEAD | CONSCIOUS | 2008-10- | -14 | -14 | Pretest | 1 | -P14D | Day 1 Dose | 2008-11- | |
Interval, | STANDARD | 28T07:46 | 11T08:54 | |||||||||||||||||||||
Aggregate | ||||||||||||||||||||||||
14 | TSA1397 | EG | 1 | 14 | QTAG | QT Interval, | SLING | 0.255 | sec | 255 | 255 | msec | LEAD II | 6 LEAD | CONSCIOUS | Y | 2008-12- | 23 | 23 | Predose | 2 | -PT5M | Day 23 | 2008-12- |
Aggregate | STANDARD | 03T09:05 | Dose | 03T09:10 | ||||||||||||||||||||
15 | TSA1397 | EG | 1 | 15 | QTAG | QT Interval, | SLING | 0.240 | sec | 240 | 240 | msec | LEAD II | 6 LEAD | CONSCIOUS | 2008-12- | 23 | 23 | 2 Hour | 3 | PT120M | Day 23 | 2008-12- | |
Aggregate | STANDARD | 03T11:03 | Postdose | Dose | 03T09:10 |
Row | STUDYID | DOMAIN | USUBJID | EGSEQ | EGTESTCD | EGTEST | EGPOS | EGORRES | EGORRESU | EGSTRESC | EGSTRESN | EGSTRESU | EGLEAD | EGMETHOD | EGCSTATE | EGBLFL | EGDTC | EGDY | EGNOMDY | EGTPT | EGTPTNUM | EGELTM | EGTPTREF | EGRFTDTC |
16 | TSA1397 | EG | 1 | 16 | QTCVAG | QTcV | SLING | 0.237 | sec | 237 | 237 | msec | LEAD II | 6 LEAD | CONSCIOUS | 2008-10- | -14 | -14 | Pretest | 1 | -P14D | Day 1 Dose | 2008-11- | |
Interval, | STANDARD | 28T07:46 | 11T08:54 | |||||||||||||||||||||
Aggregate | ||||||||||||||||||||||||
17 | TSA1397 | EG | 1 | 17 | QTCVAG | QTcV | SLING | 0.252 | sec | 252 | 252 | msec | LEAD II | 6 LEAD | CONSCIOUS | Y | 2008-12- | 23 | 23 | Predose | 2 | -PT5M | Day 23 | 2008-12- |
Interval, | STANDARD | 03T09:05 | Dose | 03T09:10 | ||||||||||||||||||||
Aggregate | ||||||||||||||||||||||||
18 | TSA1397 | EG | 1 | 18 | QTCVAG | QTcV | SLING | 0.234 | sec | 234 | 234 | msec | LEAD II | 6 LEAD | CONSCIOUS | 2008-12- | 23 | 23 | 2 Hour | 3 | PT120M | Day 23 | 2008-12- | |
Interval, | STANDARD | 03T11:03 | Postdose | Dose | 03T09:10 | |||||||||||||||||||
Aggregate |
Example 2
This example is for a cardiovascular assessment in telemetered animals where the results are averages derived by the equipment/device from multiple 1-hour intervals during a continuous 48-hour collection period. Means have been calculated from waveform data for 6 specific intervals within the entire collection period. A single planned dose, described in EGTPTREF, was given on day 1 at 06:15
(EGRFTDTC="2009-04-15T06:15"). The planned 1-hour intervals are represented by the start (EGSTINT) and end (EGENINT) of the evaluation relative to the referenced dose (EGTPTREF). Each of the 6 intervals has a text label (e.g., "Predose", "1 hr Postdose") indicated in the EGTPT variable. The sponsor has defined the labels to be the end of the interval relative to the referenced dose. The entry in EGTPT is represented in ISO 8601 format in the EGELTM variable. The actual start and end date/time variables (EGDTC and EGENDTC) are the start and end of the evaluation interval, not the date and time of the entire continuous collection period.
Row | STUDYID | DOMAIN | USUBJID | EGSEQ | EGTESTCD | EGTEST | EGPOS | EGORRES | EGORRESU | EGSTRESC | EGSTRESN | EGSTRESU | EGLEAD | EGMETHOD | EGCSTATE | EGBLFL | EGDTC | EGDY | EGENDTC | EGENDY | EGNOMDY | EGTPT | EGTPTNUM | EGELTM | EGTPTREF | EGRFTDTC | EGSTINT | EGENINT |
1 | XYZ | EG | XYZ-001- 001 | 1 | RRAG | RR Interval, Aggregate | UNCONSTRAINED | 248.11 | msec | 248.11 | 248.11 | msec | LEAD I | 12 LEAD STANDARD | CONSCIOUS | Y | 2009-04- 15T05:12:15 | 1 | 2009-04- 15T06:12:15 | 1 | 1 | Predose | 0 | PT0H | DAY 1 DOSING | 2009-04- 15T06:15 | -PT1H | PT0H |
2 | XYZ | EG | XYZ-001- 001 | 2 | EGHR | ECG Mean Heart Rate | UNCONSTRAINED | 241.8 | beats/min | 241.8 | 241.8 | beats/min | LEAD I | 12 LEAD STANDARD | CONSCIOUS | Y | 2009-04- 15T05:12:15 | 1 | 2009-04- 15T06:12:15 | 1 | 1 | Predose | 0 | PT0H | DAY 1 DOSING | 2009-04- 15T06:15 | -PT1H | PT0H |
3 | XYZ | EG | XYZ-001- 001 | 3 | QTAG | QT Interval, Aggregate | UNCONSTRAINED | 132.17 | msec | 132.17 | 132.17 | msec | LEAD I | 12 LEAD STANDARD | CONSCIOUS | Y | 2009-04- 15T05:12:15 | 1 | 2009-04- 15T06:12:15 | 1 | 1 | Predose | 0 | PT0H | DAY 1 DOSING | 2009-04- 15T06:15 | -PT1H | PT0H |
4 | XYZ | EG | XYZ-001- 001 | 4 | QTCFAG | QTcF Interval, Aggregate | UNCONSTRAINED | 211.91 | msec | 211.91 | 211.91 | msec | LEAD I | 12 LEAD STANDARD | CONSCIOUS | Y | 2009-04- 15T05:12:15 | 1 | 2009-04- 15T06:12:15 | 1 | 1 | Predose | 0 | PT0H | DAY 1 DOSING | 2009-04- 15T06:15 | -PT1H | PT0H |
5 | XYZ | EG | XYZ-001- 001 | 5 | RRAG | RR Interval, Aggregate | UNCONSTRAINED | 354.13 | msec | 354.13 | 354.13 | msec | LEAD I | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 15T06:12:15 | 1 | 2009-04- 15T07:12:15 | 1 | 1 | 1h Postdose | 1 | PT1H | DAY 1 DOSING | 2009-04- 15T06:15 | PT0H | PT1H | |
6 | XYZ | EG | XYZ-001- 001 | 6 | EGHR | ECG Mean Heart Rate | UNCONSTRAINED | 169.4 | beats/min | 169.4 | 169.4 | beats/min | LEAD I | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 15T06:12:15 | 1 | 2009-04- 15T07:12:15 | 1 | 1 | 1h Postdose | 1 | PT1H | DAY 1 DOSING | 2009-04- 15T06:15 | PT0H | PT1H | |
7 | XYZ | EG | XYZ-001- 001 | 7 | QTAG | QT Interval, Aggregate | UNCONSTRAINED | 150.19 | msec | 150.19 | 150.19 | msec | LEAD I | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 15T06:12:15 | 1 | 2009-04- 15T07:12:15 | 1 | 1 | 1h Postdose | 1 | PT1H | DAY 1 DOSING | 2009-04- 15T06:15 | PT0H | PT1H | |
8 | XYZ | EG | XYZ-001- 001 | 8 | QTCFAG | QTcF Interval, Aggregate | UNCONSTRAINED | 213.34 | msec | 213.34 | 213.34 | msec | LEAD I | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 15T06:12:15 | 1 | 2009-04- 15T07:12:15 | 1 | 1 | 1h Postdose | 1 | PT1H | DAY 1 DOSING | 2009-04- 15T06:15 | PT0H | PT1H | |
9 | XYZ | EG | XYZ-001- 001 | 9 | RRAG | RR Interval, Aggregate | UNCONSTRAINED | 363.43 | msec | 363.43 | 363.43 | msec | LEAD I | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 15T07:12:15 | 1 | 2009-04- 15T08:12:15 | 1 | 1 | 2h Postdose | 2 | PT2H | DAY 1 DOSING | 2009-04- 15T06:15 | PT1H | PT2H | |
10 | XYZ | EG | XYZ-001- 001 | 10 | EGHR | ECG Mean Heart Rate | UNCONSTRAINED | 165.1 | beats/min | 165.1 | 165.1 | beats/min | LEAD I | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 15T07:12:15 | 1 | 2009-04- 15T08:12:15 | 1 | 1 | 2h Postdose | 2 | PT2H | DAY 1 DOSING | 2009-04- 15T06:15 | PT1H | PT2H |
Row | STUDYID | DOMAIN | USUBJID | EGSEQ | EGTESTCD | EGTEST | EGPOS | EGORRES | EGORRESU | EGSTRESC | EGSTRESN | EGSTRESU | EGLEAD | EGMETHOD | EGCSTATE | EGBLFL | EGDTC | EGDY | EGENDTC | EGENDY | EGNOMDY | EGTPT | EGTPTNUM | EGELTM | EGTPTREF | EGRFTDTC | EGSTINT | EGENINT |
11 | XYZ | EG | XYZ-001- 001 | 11 | QTAG | QT Interval, Aggregate | UNCONSTRAINED | 150.82 | msec | 150.82 | 150.82 | msec | LEAD I | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 15T07:12:15 | 1 | 2009-04- 15T08:12:15 | 1 | 1 | 2h Postdose | 2 | PT2H | DAY 1 DOSING | 2009-04- 15T06:15 | PT1H | PT2H | |
12 | XYZ | EG | XYZ-001- 001 | 12 | QTCFAG | QTcF Interval, Aggregate | UNCONSTRAINED | 212.35 | msec | 212.35 | 212.35 | msec | LEAD I | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 15T07:12:15 | 1 | 2009-04- 15T08:12:15 | 1 | 1 | 2h Postdose | 2 | PT2H | DAY 1 DOSING | 2009-04- 15T06:15 | PT1H | PT2H | |
13 | XYZ | EG | XYZ-001- 001 | 13 | RRAG | RR Interval, Aggregate | UNCONSTRAINED | 361.04 | msec | 361.04 | 361.04 | msec | LEAD I | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 15T08:12:15 | 1 | 2009-04- 15T09:12:15 | 1 | 1 | 3h Postdose | 3 | PT3H | DAY 1 DOSING | 2009-04- 15T06:15 | PT2H | PT3H | |
14 | XYZ | EG | XYZ-001- 001 | 14 | EGHR | ECG Mean Heart Rate | UNCONSTRAINED | 166.2 | beats/min | 166.2 | 166.2 | beats/min | LEAD I | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 15T08:12:15 | 1 | 2009-04- 15T09:12:15 | 1 | 1 | 3h Postdose | 3 | PT3H | DAY 1 DOSING | 2009-04- 15T06:15 | PT2H | PT3H | |
15 | XYZ | EG | XYZ-001- 001 | 15 | QTAG | QT Interval, Aggregate | UNCONSTRAINED | 149.01 | msec | 149.01 | 149.01 | msec | LEAD I | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 15T08:12:15 | 1 | 2009-04- 15T09:12:15 | 1 | 1 | 3h Postdose | 3 | PT3H | DAY 1 DOSING | 2009-04- 15T06:15 | PT2H | PT3H | |
16 | XYZ | EG | XYZ-001- 001 | 16 | QTCFAG | QTcF Interval, Aggregate | UNCONSTRAINED | 210.76 | msec | 210.76 | 210.76 | msec | LEAD I | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 15T08:12:15 | 1 | 2009-04- 15T09:12:15 | 1 | 1 | 3h Postdose | 3 | PT3H | DAY 1 DOSING | 2009-04- 15T06:15 | PT2H | PT3H | |
17 | XYZ | EG | XYZ-001- 001 | 17 | RRAG | RR Interval, Aggregate | UNCONSTRAINED | 360.23 | msec | 360.23 | 360.23 | msec | LEAD I | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 16T05:12:15 | 2 | 2009-04- 16T06:12:15 | 2 | 1 | 24h Postdose | 4 | PT24H | DAY 1 DOSING | 2009-04- 15T06:15 | PT23H | PT24H | |
18 | XYZ | EG | XYZ-001- 001 | 18 | EGHR | ECG Mean Heart Rate | UNCONSTRAINED | 166.6 | beats/min | 166.6 | 166.6 | beats/min | LEAD I | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 16T05:12:15 | 2 | 2009-04- 16T06:12:15 | 2 | 1 | 24h Postdose | 4 | PT24H | DAY 1 DOSING | 2009-04- 15T06:15 | PT23H | PT24H | |
19 | XYZ | EG | XYZ-001- 001 | 19 | QTAG | QT Interval, Aggregate | UNCONSTRAINED | 147.98 | msec | 147.98 | 147.98 | msec | LEAD I | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 16T05:12:15 | 2 | 2009-04- 16T06:12:15 | 2 | 1 | 24h Postdose | 4 | PT24H | DAY 1 DOSING | 2009-04- 15T06:15 | PT23H | PT24H | |
20 | XYZ | EG | XYZ-001- 001 | 20 | QTCFAG | QTcF Interval, Aggregate | UNCONSTRAINED | 209.40 | msec | 209.40 | 209.40 | msec | LEAD I | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 16T05:12:15 | 2 | 2009-04- 16T06:12:15 | 2 | 1 | 24h Postdose | 4 | PT24H | DAY 1 DOSING | 2009-04- 15T06:15 | PT23H | PT24H | |
21 | XYZ | EG | XYZ-001- 001 | 21 | RRAG | RR Interval, Aggregate | UNCONSTRAINED | 259.89 | msec | 259.89 | 259.89 | msec | LEAD I | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 17T05:12:15 | 3 | 2009-04- 17T06:12:15 | 3 | 1 | 48h Postdose | 5 | PT48H | DAY 1 DOSING | 2009-04- 15T06:15 | PT47H | PT48H | |
22 | XYZ | EG | XYZ-001- 001 | 22 | EGHR | ECG Mean Heart Rate | UNCONSTRAINED | 230.9 | beats/min | 230.9 | 230.9 | beats/min | LEAD I | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 17T05:12:15 | 3 | 2009-04- 17T06:12:15 | 3 | 1 | 48h Postdose | 5 | PT48H | DAY 1 DOSING | 2009-04- 15T06:15 | PT47H | PT48H | |
23 | XYZ | EG | XYZ-001- 001 | 23 | QTAG | QT Interval, Aggregate | UNCONSTRAINED | 133.67 | msec | 133.67 | 133.67 | msec | LEAD I | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 17T05:12:15 | 3 | 2009-04- 17T06:12:15 | 3 | 1 | 48h Postdose | 5 | PT48H | DAY 1 DOSING | 2009-04- 15T06:15 | PT47H | PT48H | |
24 | XYZ | EG | XYZ-001- 001 | 24 | QTCFAG | QTcF Interval, Aggregate | UNCONSTRAINED | 210.99 | msec | 210.99 | 210.99 | msec | LEAD I | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 17T05:12:15 | 3 | 2009-04- 17T06:12:15 | 3 | 1 | 48h Postdose | 5 | PT48H | DAY 1 DOSING | 2009-04- 15T06:15 | PT47H | PT48H |
As previously noted, in the above example, the sponsor has defined the interval labels to be the end of the interval relative to the referenced dose. However, sponsors may label time points differently, such as from the beginning or midpoint of the interval, or use another form of labeling. In these cases, the period of evaluation (defined by EGSTINT and EGENINT) does not change, just the label (EGTPT) and its standard representation (EGELTM).
The following is a sampling of rows from the above example, with only the timing variables. Regardless of the method of labeling for the time points, the same periods of evaluation apply.
eg.xpt
Row | EGDTC | EGDY | EGENDTC | EGENDY | EGNOMDY | EGTPT | EGTPTNUM | EGELTM | EGTPTREF | EGRFTDTC | EGSTINT | EGENINT |
1 | 2009-04-15T05:12:15 | 1 | 2009-04-15T06:12:15 | 1 | 1 | (see below) | 0 | (see below) | DAY 1 DOSING | 2009-04-15T06:15 | -PT1H | PT0H |
5 | 2009-04-15T06:12:15 | 1 | 2009-04-15T07:12:15 | 1 | 1 | (see below) | 1 | (see below) | DAY 1 DOSING | 2009-04-15T06:15 | PT0H | PT1H |
9 | 2009-04-15T07:12:15 | 1 | 2009-04-15T08:12:15 | 1 | 1 | (see below) | 2 | (see below) | DAY 1 DOSING | 2009-04-15T06:15 | PT1H | PT2H |
13 | 2009-04-15T08:12:15 | 1 | 2009-04-15T09:12:15 | 1 | 1 | (see below) | 3 | (see below) | DAY 1 DOSING | 2009-04-15T06:15 | PT2H | PT3H |
The following are variations on the time point labeling (EGTPT) and duration to the time point (EGELTM) for the same periods of evaluation.
End-based | Start-based | Midpoint-based | Range Description | |||||||||||
Row | EGTPT | EGELTM | Row | EGTPT | EGELTM | Row | EGTPT | EGELTM | Row | EGTPT | EGELTM | |||
1 | Predose | PT0H | 1 | -1 hour predose | -PT1H | 1 | Predose | -PT30M | 1 | -1 to 0 hour post | ||||
5 | 1h Postdose | PT1H | 5 | 0 hour postdose | PT0H | 5 | 30 min | PT30M | 5 | 0 to 1 hour post | ||||
9 | 2h Postdose | PT2H | 9 | 1 hour postdose | PT1H | 9 | 1 hr 30 min | PT1H30M | 9 | 1 to 2 hour post | ||||
In this case, intervals are labeled based on the end of the interval (e.g., the 1- to 2-hour post-dose interval is labeled as "2h Postdose"). This example is the same as that used in the full example above. | In this case, intervals are labeled based on the start of the interval (e.g., the 1- to 2-hour post-dose interval is labeled as "1 hour postdose”. | In this case, intervals are labeled based on the midpoint of the interval (e.g., the 1- to 2-hour post-dose interval is labeled as "1 hr 30 min”. | In this case, intervals are labeled based on the time range (e.g., the 1- to 2-hour post-dose interval is labeled as "1 to 2 hour post"). The time point does not have a determinate time from the reference point, so EGELTM is blank. | |||||||||||
Example 3
This example shows how ECG measurements, interpretations, and diagnoses may be shown within the EG domain.
eg.xpt
Row | STUDYID | DOMAIN | USUBJID | EGSEQ | EGGRPID | EGTESTCD | EGTEST | EGCAT | EGPOS | EGORRES | EGORRESU | EGSTRESC | EGSTRESN | EGSTRESU | EGLEAD | EGMETHOD | EGCSTATE | EGBLFL | EGEVAL | EGDTC | EGDY | EGNOMDY | EGTPT | EGTPTNUM | EGTPTREF | EGRFTDTC |
1 | XYZ | EG | XYZ-001- 001 | 1 | 1 | QTAG | QT Interval, Aggregate | MEASUREMENT | UNCONSTRAINED | 132.172 | msec | 132.172 | 132.172 | msec | LEAD I | 12 LEAD STANDARD | CONSCIOUS | 2009-01- 15T06:00 | 1 | 1 | Predose | 0 | Day 1 Dose | 2009-01- 15T07:00 | ||
2 | XYZ | EG | XYZ-001- 001 | 2 | 1 | INTP | Interpretation | INTERPRETATION | UNCONSTRAINED | QT MEAN POSSIBLY ABNORMAL | QT MEAN POSSIBLY ABNORMAL | TECHNICIAN | 2009-01- 15T06:00 | 1 | 1 | Predose | 0 | Day 1 Dose | 2009-01- 15T07:00 | |||||||
3 | XYZ | EG | XYZ-001- 001 | 3 | 1 | INTP | Interpretation | DIAGNOSIS | UNCONSTRAINED | PROLONGED QT | PROLONGED QT | CARDIOLOGIST | 2009-01- 15T06:00 | 1 | 1 | Predose | 0 | Day 1 Dose | 2009-01- 15T07:00 | |||||||
4 | XYZ | EG | XYZ-001- 002 | 1 | 2 | TWARAG | T Wave Area, Aggregate | MEASUREMENT | UNCONSTRAINED | -211.905 | msec | -211.905 | -211.905 | msec | LEAD I | 12 LEAD STANDARD | CONSCIOUS | 2009-01- 15T06:00 | 1 | 1 | Predose | 0 | Day 1 Dose | 2009-01- 15T07:00 | ||
5 | XYZ | EG | XYZ-001- 002 | 2 | 2 | INTP | Interpretation | INTERPRETATION | UNCONSTRAINED | T WAVE INVERSION | T WAVE ABNORMALITY | ECG ANALYST | 2009-01- 15T06:00 | 1 | 1 | Predose | 0 | Day 1 Dose | 2009-01- 15T07:00 | |||||||
6 | XYZ | EG | XYZ-001- 002 | 3 | 2 | INTP | Interpretation | DIAGNOSIS | UNCONSTRAINED | LEFT VENTRICULAR HYPERTROPHY | LEFT VENTRICULAR HYPERTROPHY | CARDIOLOGIST | 2009-01- 15T06:00 | 1 | 1 | Predose | 0 | Day 1 Dose | 2009-01- 15T07:00 | |||||||
7 | XYZ | EG | XYZ-001- 002 | 4 | 2 | INTP | Interpretation | DIAGNOSIS | UNCONSTRAINED | JUNCTIONAL TACHYCARDIA | JUNCTIONAL TACHYCARDIA | CARDIOLOGIST | 2009-01- 15T06:00 | 1 | 1 | Predose | 0 | Day 1 Dose | 2009-01- 15T07:00 |
Example 4
The study design for this example is to determine a suspected toxicity of the heart. The same test parameters were collected from different leads identifiers, using different methods, and summarized at different time points. The data is summarized for an hour-long interval after the day 1 dose, as indicated by EGSTINT and EGENINT.
eg.xpt
Row | STUDYID | DOMAIN | USUBJID | EGSEQ | EGTESTCD | EGTEST | EGPOS | EGORRES | EGORRESU | EGSTRESC | EGSTRESN | EGSTRESU | EGLEAD | EGMETHOD | EGCSTATE | EGBLFL | EGDTC | EGDY | EGNOMDY | EGTPT | EGTPTNUM | EGELTM | EGTPTREF | EGRFTDTC | EGSTINT | EGENINT |
1 | XYZ | EG | XYZ-101- 101 | 1 | RRAG | RR Interval, Aggregate | UNCONSTRAINED | 248.105 | msec | 248.105 | 248.105 | msec | LEAD CV5RL | 6 LEAD STANDARD | CONSCIOUS | 2009-04- 15T07:00 | 1 | 1 | 1H POSTDOSE | 1 | PT1H | Day 1 Dose | 2009-04- 15T06:00 | PT0H | PT1H | |
2 | XYZ | EG | XYZ-101- 101 | 2 | EGHRMN | ECG Mean Heart Rate | UNCONSTRAINED | 241.833 | beats/min | 241.833 | 241.833 | beats/min | LEAD CV5RL | 6 LEAD STANDARD | CONSCIOUS | 2009-04- 15T07:00 | 1 | 1 | 1H POSTDOSE | 1 | PT1H | Day 1 Dose | 2009-04- 15T06:00 | PT0H | PT1H | |
3 | XYZ | EG | XYZ-101- 101 | 3 | QTAG | QT Interval, Aggregate | UNCONSTRAINED | 132.172 | msec | 132.172 | 132.172 | msec | LEAD CV5RL | 6 LEAD STANDARD | CONSCIOUS | 2009-04- 15T07:00 | 1 | 1 | 1H POSTDOSE | 1 | PT1H | Day 1 Dose | 2009-04- 15T06:00 | PT0H | PT1H | |
4 | XYZ | EG | XYZ-101- 101 | 4 | QTCFAG | QTcF Interval, Aggregate | UNCONSTRAINED | 211.905 | msec | 211.905 | 211.905 | msec | LEAD CV5RL | 6 LEAD STANDARD | CONSCIOUS | 2009-04- 15T07:00 | 1 | 1 | 1H POSTDOSE | 1 | PT1H | Day 1 Dose | 2009-04- 15T06:00 | PT0H | PT1H | |
5 | XYZ | EG | XYZ-201- 201 | 5 | RRAG | RR Interval, Aggregate | STANDING | 354.13 | msec | 354.13 | 354.13 | msec | LEAD II | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 15T07:00 | 1 | 1 | 1H POSTDOSE | 1 | PT1H | Day 1 Dose | 2009-04- 15T06:00 | PT0H | PT1H | |
6 | XYZ | EG | XYZ-201- 201 | 6 | EGHRMN | ECG Mean Heart Rate | STANDING | 169.429 | beats/min | 169.429 | 169.429 | beats/min | LEAD II | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 15T07:00 | 1 | 1 | 1H POSTDOSE | 1 | PT1H | Day 1 Dose | 2009-04- 15T06:00 | PT0H | PT1H | |
7 | XYZ | EG | XYZ-201- 201 | 7 | QTAG | QT Interval, Aggregate | STANDING | 150.19 | msec | 150.19 | 150.19 | msec | LEAD II | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 15T07:00 | 1 | 1 | 1H POSTDOSE | 1 | PT1H | Day 1 Dose | 2009-04- 15T06:00 | PT0H | PT1H | |
8 | XYZ | EG | XYZ-201- 201 | 8 | QTCFAG | QTcF Interval, Aggregate | STANDING | 213.335 | msec | 213.335 | 213.335 | msec | LEAD II | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 15T07:00 | 1 | 1 | 1H POSTDOSE | 1 | PT1H | Day 1 Dose | 2009-04- 15T06:00 | PT0H | PT1H | |
9 | XYZ | EG | XYZ-301- 301 | 9 | RRAG | RR Interval, Aggregate | UNCONSTRAINED | 363.428 | msec | 363.428 | 363.428 | msec | LEAD I | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 15T07:00 | 1 | 1 | 1H POSTDOSE | 1 | PT1H | Day 1 Dose | 2009-04- 15T06:00 | PT0H | PT1H | |
10 | XYZ | EG | XYZ-301- 301 | 10 | EGHRMN | ECG Mean Heart Rate | UNCONSTRAINED | 165.1 | beats/min | 165.1 | 165.1 | beats/min | LEAD I | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 15T07:00 | 1 | 1 | 1H POSTDOSE | 1 | PT1H | Day 1 Dose | 2009-04- 15T06:00 | PT0H | PT1H | |
11 | XYZ | EG | XYZ-301- 301 | 11 | QTAG | QT Interval, Aggregate | UNCONSTRAINED | 150.819 | msec | 150.819 | 150.819 | msec | LEAD I | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 15T07:00 | 1 | 1 | 1H POSTDOSE | 1 | PT1H | Day 1 Dose | 2009-04- 15T06:00 | PT0H | PT1H | |
12 | XYZ | EG | XYZ-301- 301 | 12 | QTCFAG | QTcF Interval, Aggregate | UNCONSTRAINED | 212.351 | msec | 212.351 | 212.351 | msec | LEAD I | 12 LEAD STANDARD | CONSCIOUS | 2009-04- 15T07:00 | 1 | 1 | 1H POSTDOSE | 1 | PT1H | Day 1 Dose | 2009-04- 15T06:00 | PT0H | PT1H |
Cardiovascular Test Results – CV
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
DOMAIN | Domain Abbreviation | Char | CV | Identifier | Two-character abbreviation for the domain. | Req |
USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all application or submissions involving the product. | Req | |
CVSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | |
CVGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject and can be used to support relationships within the domain and between domains using RELREC. This is not the treatment group number. | Perm | |
CVSPID | Sponsor-Defined Identifier | Char | Identifier | Sponsor-defined reference identifier | Perm | |
CVTESTCD | Test Short Name | Char | Topic | Short name of the measurement, test, or examination described in CVTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in CVTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). CVTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: DIABP, HR, MAP, SYSBP. | Req | |
CVTEST | Test Name | Char | Synonym Qualifier | Long name for CVTESTCD. The value in CVTEST cannot be longer than 40 characters. Examples: Diastolic Blood Pressure, Heart Rate, Mean Arterial Pressure, Systolic Blood Pressure. | Req | |
CVPOS | Position of Subject During Test | Char | Record Qualifier | Position of the subject during the measurement or examination. If the subject is restrained, populate with the position (example SITTING or STANDING); otherwise, populate with UNCONSTRAINED. | Exp | |
CVORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp | |
CVORRESU | Unit of the Original Result | Char | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology (http://www.cdisc.org/terminology) list. | Exp | |
CVSTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from CVORRES in a standard format or standard units. CVSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in CVSTRESN. | Exp | |
CVSTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for continuous or numeric results or findings in standard format; contains the numeric form of CVSTRESC. CVSTRESN should store all numeric test results or findings. | Exp | |
CVSTRESU | Unit of the Standardized Result | Char | Variable Qualifier | Standardized unit used for CVSTRESC and CVSTRESN. | Exp | |
CVSTAT | Completion Status | Char | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in CVORRES. | Perm |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
CVREASND | Reason Not Done | Char | Record Qualifier | Describes why CVSTAT is NOT DONE, such as BROKEN EQUIPMENT. | Perm | |
CVMETHOD | Method of Test | Char | Record Qualifier | Method of the test or examination. Examples: Intravascular, External Cuff. | Exp | |
CVCSTATE | Consciousness State | Char | Record Qualifier | Consciousness state of the subject at the time of measurement. Examples: CONSCIOUS, SEMI- CONSCIOUS, UNCONSCIOUS. | Exp | |
CVBLFL | Baseline Flag | Char | Record Qualifier | A baseline indicator may be used to calculate differences or changes from baseline. Value should be Y or null. The baseline flag is sponsor defined. | Exp | |
CVDRVFL | Derived Flag | Char | Record Qualifier | Used to indicate a derived record. The value should be Y or null. | Perm | |
CVEXCLFL | Exclusion Flag | Char | Record Qualifier | Y if the result should be excluded from all calculations, otherwise null. | Perm | |
CVREASEX | Reason for Exclusion | Char | Record Qualifier | The reason the result should be excluded from all calculations. Used only when CVEXCLFL is Y. | Perm | |
CVUSCHFL | Unscheduled Flag | Char | Record Qualifier | Indicates whether the timing of the performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null. | Perm | |
CVDTC | Date/Time of Cardiovascular Test | Char | ISO 8601 | Timing | Date/Time of cardiovascular data collection, in ISO 8601 format. For measurements related to a continuous evaluation interval, CVDTC should be used to indicate the start date/time of that interval. | Exp |
CVENDTC | End Date/Time of Cardiovascular Test | Char | ISO 8601 | Timing | Date/Time of end of a cardiovascular evaluation interval, in ISO 8601 format. Should be populated when CVDTC represents the start date/time of a continuous evaluation interval. | Perm |
CVDY | Study Day of Cardiovascular Test | Num | Timing | Study day of cardiovascular data collection, in integer days. For measurements related to a continuous evaluation interval, CVDY can be used to indicate start day of that interval. The algorithm for calculating the day must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | |
CVENDY | Study Day of End of Cardiovascular Test | Num | Timing | Study day of the end of a cardiovascular evaluation interval, in integer days. Can be populated when CVDY represents the start day of a continuous evaluation interval. The algorithm for calculating the day must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | |
CVNOMDY | Nominal Study Day for Tabulations | Num | Timing | Nominal study day used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer. | Exp | |
CVNOMLBL | Label for Nominal Study Day | Char | Timing | A label for a given value of CVNOMDY as presented in the study report Examples: Pretreatment, Week 4, Day 28. | Perm | |
CVTPT | Planned Time Point Name | Char | Timing | Text description of time when data should be collected. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See CVTPTNUM and CVTPTREF. Examples: Predose, 1 Hour Postdose. | Exp | |
CVTPTNUM | Planned Time Point Number | Num | Timing | Numerical version of CVTPT to aid in sorting. | Exp |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
CVELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 | Timing | Planned elapsed time (in ISO 8601 format) relative to a fixed time point reference (CVTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: "-PT15M" to represent the period of 15 minutes prior to the reference point indicated by CVTPTREF, or "PT8H" to represent the period of 8 hours after the reference point indicated by CVTPTREF. | Exp |
CVTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by CVELTM, if used for CVTPTNUM, and CVTPT. It is recommended that CVTPTREF be as descriptive as possible so the reference time point can be inferred without looking at others variables. Example: DAY 1 FIRST DOSE. | Exp | |
CVRFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 | Timing | Date/Time of the reference time point, CVTPTREF. | Perm |
CVEVLINT | Evaluation Interval | Char | ISO 8601 | Timing | Length of evaluation interval in ISO 8601 duration format. Used in place of CVSTINT and CVENINT when CVTPTREF is not available. | Perm |
CVSTINT | Planned Start of Assessment Interval | Char | ISO 8601 | Timing | Planned start of an assessment interval relative to Time Point Reference (CVTPTREF) in ISO 8601 duration format. Example: When the evaluation interval is from 1 to 2 hours after dosing, the value would be PT1H. | Exp |
CVENINT | Planned End of Assessment Interval | Char | ISO 8601 | Timing | Planned end of an assessment interval relative to Time Point Reference (CVTPTREF) in ISO 8601 duration format. Example: When the evaluation interval is from 1 to 2 hours after dosing, the value would be PT2H. | Exp |
Assumptions for Cardiovascular (CV) Domain Model
The DV domain contains dynamic measurements, collected or derived, related to the cardiovascular system, except those that follow the definition of the measurements in the ECG Test Results (EG) domain.
The timing variables CVDTC, CVENDTC, CVDY, and CVENDY are used to represent the actual start and end of the evaluation period during which data that contributed to the reported result were collected. This may be a portion of a longer period over which the instrument was continuously collecting data.
CVSTINT and CVENINT should be used to describe a known assessment interval whenever there is a reference time point (CVTPTREF).
CVMETHOD and CVCSTATE are considered important for comparison purposes and should be populated whenever available or collected.
Examples for Cardiovascular (CV) Domain Model
The CV, ECG Test Results (EG), and Respiratory Test Results (RE) domains are very similar in structure. Note that the examples provided in this section represent uses of timing variables which could apply to any of these domains, regardless of study type or design.
Example 1
This example shows different cardiovascular endpoints collected for 1 subject, including examples of both collected and derived baseline measurements. These endpoints were measured at a single point in time at 8 hours post-dose (CVELTM = "PT8H"), per the study protocol. Since the time point is not an interval with a planned start and end, CVSTINT and CVENINT are null.
cv.xpt
Row | STUDYID | DOMAIN | USUBJID | CVSEQ | CVTESTCD | CVTEST | CVPOS | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVMETHOD | CVCSTATE | CVBLFL | CVDRVFL | CVDTC | CVDY | CVNOMDY | CVTPT | CVTPTNUM | CVELTM | CVTPTREF | CVSTINT | CVENINT |
1 | ABC | CV | ABC-001- | 1 | SYSBP | Systolic | SITTING | 154 | mmHg | 154 | 154 | mmHg | External | CONSCIOUS | 1999-06- | 1 | 1 | 8 hours | 1 | PT8H | Day 1 Dose | ||||
001 | Blood | Cuff | 19T08:45 | postdose | |||||||||||||||||||||
Pressure | |||||||||||||||||||||||||
2 | ABC | CV | ABC-001- | 2 | SYSBP | Systolic | SITTING | 152 | mmHg | 152 | 152 | mmHg | External | CONSCIOUS | 1999-06- | 1 | 1 | 8 hours | 1 | PT8H | Day 1 Dose | ||||
001 | Blood | Cuff | 19T09:00 | postdose | |||||||||||||||||||||
Pressure | |||||||||||||||||||||||||
3 | ABC | CV | ABC-001- | 3 | SYSBP | Systolic | SITTING | 153 | mmHg | 153 | 153 | mmHg | External | CONSCIOUS | Y | Y | 1999-06- | 1 | 1 | 8 hours | 1 | PT8H | Day 1 Dose | ||
001 | Blood | Cuff | 19 | postdose | |||||||||||||||||||||
Pressure | |||||||||||||||||||||||||
4 | ABC | CV | ABC-001- | 4 | DIABP | Diastolic | SITTING | 44 | mmHg | 44 | 44 | mmHg | External | CONSCIOUS | 1999-06- | 1 | 1 | 8 hours | 1 | PT8H | Day 1 Dose | ||||
001 | Blood | Cuff | 19T08:45 | postdose | |||||||||||||||||||||
Pressure | |||||||||||||||||||||||||
5 | ABC | CV | ABC-001- | 5 | DIABP | Diastolic | SITTING | 48 | mmHg | 48 | 48 | mmHg | External | CONSCIOUS | 1999-06- | 1 | 1 | 8 hours | 1 | PT8H | Day 1 Dose | ||||
001 | Blood | Cuff | 19T09:00 | postdose | |||||||||||||||||||||
Pressure | |||||||||||||||||||||||||
6 | ABC | CV | ABC-001- | 6 | DIABP | Diastolic | SITTING | 46 | mmHg | 46 | 46 | mmHg | External | CONSCIOUS | Y | Y | 1999-06- | 1 | 1 | 8 hours | 1 | PT8H | Day 1 Dose | ||
001 | Blood | Cuff | 19 | postdose | |||||||||||||||||||||
Pressure | |||||||||||||||||||||||||
7 | ABC | CV | ABC-001- | 7 | PULSEPR | Pulse | SITTING | 107 | mmHg | 72 | 72 | mmHg | External | CONSCIOUS | Y | 1999-06- | 1 | 1 | 8 hours | 1 | PT8H | Day 1 Dose | |||
001 | Pressure | Cuff | 19 | postdose |
Example 2
This example shows measurements on 2 animals at 3 time points (baseline, 120 minutes, 240 minutes) relative to the administration of the third dose level of a Latin square design (with CVTPTREF as "Dose 3"). At each time point, several measurements were assessed (arterial diastolic pressure, arterial heart rate, arterial mean blood pressure). Each measurement summarizes data collected for a planned evaluation interval of 60 minutes that ended at time 0 min, 120 min, and 240 min after the dose. Subject 1003 received the third dose level on day 15 of the study and subject 1008 received this dose level on day 1. The method "Intravascular" is used for measurements taken directly from the vasculature.
cv.xpt
Row | STUDYID | DOMAIN | USUBJID | CVSEQ | CVTESTCD | CVTEST | CVPOS | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVMETHOD | CVCSTATE | CVBLFL | CVDTC | CVDY | CVNOMDY | CVTPT | CVTPTNUM | CVELTM | CVTPTREF | CVRFTDTC | CVSTINT | CVENINT |
1 | AA222 | CV | 1003 | 1 | DIABP | Diastolic Blood Pressure | UNCONSTRAINED | 50.94 | mmHg | 50.94 | 50.94 | mmHg | Intravascular | CONSCIOUS | Y | 2006-09- 15 | 15 | 15 | 0 min | 0 | PT0M | Dose 3 | 2006-09- 15T10:30 | -PT60M | PT0M |
2 | AA222 | CV | 1003 | 2 | DIABP | Diastolic Blood Pressure | UNCONSTRAINED | 50.68 | mmHg | 50.68 | 50.68 | mmHg | Intravascular | CONSCIOUS | 2006-09- 15 | 15 | 15 | 120 min | 120 | PT120M | Dose 3 | 2006-09- 15T10:30 | PT60M | PT120M | |
3 | AA222 | CV | 1003 | 3 | DIABP | Diastolic Blood Pressure | UNCONSTRAINED | 49.37 | mmHg | 49.37 | 49.37 | mmHg | Intravascular | CONSCIOUS | 2006-09- 15 | 15 | 15 | 240 min | 240 | PT240M | Dose 3 | 2006-09- 15T10:30 | PT180M | PT240M | |
4 | AA222 | CV | 1003 | 4 | HR | Heart Rate | UNCONSTRAINED | 139.2 | beats/min | 139.2 | 139.2 | beats/min | Intravascular | CONSCIOUS | Y | 2006-09- 15 | 15 | 15 | 0 min | 0 | PT0M | Dose 3 | 2006-09- 15T10:30 | -PT60M | PT0M |
5 | AA222 | CV | 1003 | 5 | HR | Heart Rate | UNCONSTRAINED | 128.3 | beats/min | 128.3 | 128.3 | beats/min | Intravascular | CONSCIOUS | 2006-09- 15 | 15 | 15 | 120 min | 120 | PT120M | Dose 3 | 2006-09- 15T10:30 | PT60M | PT120M |
Row | STUDYID | DOMAIN | USUBJID | CVSEQ | CVTESTCD | CVTEST | CVPOS | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVMETHOD | CVCSTATE | CVBLFL | CVDTC | CVDY | CVNOMDY | CVTPT | CVTPTNUM | CVELTM | CVTPTREF | CVRFTDTC | CVSTINT | CVENINT |
6 | AA222 | CV | 1003 | 6 | HR | Heart Rate | UNCONSTRAINED | 118.4 | beats/min | 118.4 | 118.4 | beats/min | Intravascular | CONSCIOUS | 2006-09- 15 | 15 | 15 | 240 min | 240 | PT240M | Dose 3 | 2006-09- 15T10:30 | PT180M | PT240M | |
7 | AA222 | CV | 1003 | 7 | MAP | Mean Arterial Pressure | UNCONSTRAINED | 66.96 | mmHg | 66.96 | 66.96 | mmHg | Intravascular | CONSCIOUS | Y | 2006-09- 15 | 15 | 15 | 0 min | 0 | PT0M | Dose 3 | 2006-09- 15T10:30 | -PT60M | PT0M |
8 | AA222 | CV | 1003 | 8 | MAP | Mean Arterial Pressure | UNCONSTRAINED | 66.66 | mmHg | 66.66 | 66.66 | mmHg | Intravascular | CONSCIOUS | 2006-09- 15 | 15 | 15 | 120 min | 120 | PT120M | Dose 3 | 2006-09- 15T10:30 | PT60M | PT120M | |
9 | AA222 | CV | 1003 | 9 | MAP | Mean Arterial Pressure | UNCONSTRAINED | 65.99 | mmHg | 65.99 | 65.99 | mmHg | Intravascular | CONSCIOUS | 2006-09- 15 | 15 | 15 | 240 min | 240 | PT240M | Dose 3 | 2006-09- 15T10:30 | PT180M | PT240M | |
10 | AA1111 | CV | 1008 | 10 | DIABP | Diastolic Blood Pressure | UNCONSTRAINED | 34.11 | mmHg | 34.11 | 34.11 | mmHg | Intravascular | CONSCIOUS | Y | 2006-09- 01 | 1 | 1 | 0 min | 0 | PT0M | Dose 3 | 2006-09- 01T10:30 | -PT60M | PT0M |
11 | AA1111 | CV | 1008 | 11 | DIABP | Diastolic Blood Pressure | UNCONSTRAINED | 28.63 | mmHg | 28.63 | 28.63 | mmHg | Intravascular | CONSCIOUS | 2006-09- 01 | 1 | 1 | 120 min | 120 | PT120M | Dose 3 | 2006-09- 01T10:30 | PT60M | PT120M | |
12 | AA1111 | CV | 1008 | 12 | DIABP | Diastolic Blood Pressure | UNCONSTRAINED | 28.96 | mmHg | 28.96 | 28.96 | mmHg | Intravascular | CONSCIOUS | 2006-09- 01 | 1 | 1 | 240 min | 240 | PT240M | Dose 3 | 2006-09- 01T10:30 | PT180M | PT240M | |
13 | AA1111 | CV | 1008 | 13 | HR | Heart Rate | UNCONSTRAINED | 186.1 | beats/min | 186.1 | 186.1 | beats/min | Intravascular | CONSCIOUS | Y | 2006-09- 01 | 1 | 1 | 0 min | 0 | PT0M | Dose 3 | 2006-09- 01T10:30 | -PT60M | PT0M |
14 | AA1111 | CV | 1008 | 14 | HR | Heart Rate | UNCONSTRAINED | 168.3 | beats/min | 168.3 | 168.3 | beats/min | Intravascular | CONSCIOUS | 2006-09- 01 | 1 | 1 | 120 min | 120 | PT120M | Dose 3 | 2006-09- 01T10:30 | PT60M | PT120M | |
15 | AA1111 | CV | 1008 | 15 | HR | Heart Rate | UNCONSTRAINED | 150.8 | beats/min | 150.8 | 150.8 | beats/min | Intravascular | CONSCIOUS | 2006-09- 01 | 1 | 1 | 240 min | 240 | PT240M | Dose 3 | 2006-09- 01T10:30 | PT180M | PT240M | |
16 | AA1111 | CV | 1008 | 16 | MAP | Mean Arterial Pressure | UNCONSTRAINED | 53.48 | mmHg | 53.48 | 53.48 | mmHg | Intravascular | CONSCIOUS | Y | 2006-09- 01 | 1 | 1 | 0 min | 0 | PT0M | Dose 3 | 2006-09- 01T10:30 | -PT60M | PT0M |
17 | AA1111 | CV | 1008 | 17 | MAP | Mean Arterial Pressure | UNCONSTRAINED | 47.67 | mmHg | 47.67 | 47.67 | mmHg | Intravascular | CONSCIOUS | 2006-09- 01 | 1 | 1 | 120 min | 120 | PT120M | Dose 3 | 2006-09- 01T10:30 | PT60M | PT120M | |
18 | AA1111 | CV | 1008 | 18 | MAP | Mean Arterial Pressure | UNCONSTRAINED | 46.48 | mmHg | 46.48 | 46.48 | mmHg | Intravascular | CONSCIOUS | 2006-09- 01 | 1 | 1 | 240 min | 240 | PT240M | Dose 3 | 2006-09- 01T10:30 | PT180M | PT240M |
Example 3
This example shows heart rates for a single animal where the evaluation intervals changed across the study. The sponsor chose to label its time points (CVTPT) based on the hours, minutes, and seconds of the planned time away from dose, based on the end of the evaluation interval.
Row | STUDYID | DOMAIN | USUBJID | CVSEQ | CVTESTCD | CVTEST | CVPOS | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVMETHOD | CVCSTATE | CVBLFL | CVDTC | CVDY | CVNOMDY | CVTPT | CVTPTNUM | CVELTM | CVTPTREF | CVRFTDTC | CVSTINT | CVENINT |
1 | ABC-123 | CV | 101 | 1 | HR | Heart Rate | UNCONSTRAINED | 162 | beats/min | 162 | 162 | beats/min | Intravascular | CONSCIOUS | Y | 2012-03-22 | 1 | 1 | 00:00:00 | 1 | PT0M | Day 1 Dose | 2012-03-22T09:52 | -PT1H | PT0M |
2 | ABC-123 | CV | 101 | 2 | HR | Heart Rate | UNCONSTRAINED | 158 | beats/min | 158 | 158 | beats/min | Intravascular | CONSCIOUS | 2012-03-22 | 1 | 1 | 00:15:00 | 2 | PT15M | Day 1 Dose | 2012-03-22T09:52 | PT0M | PT15M | |
3 | ABC-123 | CV | 101 | 3 | HR | Heart Rate | UNCONSTRAINED | 152 | beats/min | 152 | 152 | beats/min | Intravascular | CONSCIOUS | 2012-03-22 | 1 | 1 | 00:30:00 | 3 | PT30M | Day 1 Dose | 2012-03-22T09:52 | PT15M | PT30M | |
4 | ABC-123 | CV | 101 | 4 | HR | Heart Rate | UNCONSTRAINED | 141 | beats/min | 141 | 141 | beats/min | Intravascular | CONSCIOUS | 2012-03-22 | 1 | 1 | 00:45:00 | 4 | PT45M | Day 1 Dose | 2012-03-22T09:52 | PT30M | PT45M | |
5 | ABC-123 | CV | 101 | 5 | HR | Heart Rate | UNCONSTRAINED | 120 | beats/min | 120 | 120 | beats/min | Intravascular | CONSCIOUS | 2012-03-22 | 1 | 1 | 01:00:00 | 5 | PT1H | Day 1 Dose | 2012-03-22T09:52 | PT45M | PT1H | |
6 | ABC-123 | CV | 101 | 6 | HR | Heart Rate | UNCONSTRAINED | 113 | beats/min | 113 | 113 | beats/min | Intravascular | CONSCIOUS | 2012-03-22 | 1 | 1 | 01:15:00 | 6 | PT1H15M | Day 1 Dose | 2012-03-22T09:52 | PT1H | PT1H15M | |
7 | ABC-123 | CV | 101 | 7 | HR | Heart Rate | UNCONSTRAINED | 123 | beats/min | 123 | 123 | beats/min | Intravascular | CONSCIOUS | 2012-03-22 | 1 | 1 | 01:30:00 | 7 | PT1H30M | Day 1 Dose | 2012-03-22T09:52 | PT1H15M | PT1H30M | |
8 | ABC-123 | CV | 101 | 8 | HR | Heart Rate | UNCONSTRAINED | 143 | beats/min | 143 | 143 | beats/min | Intravascular | CONSCIOUS | 2012-03-22 | 1 | 1 | 01:45:00 | 8 | PT1H45M | Day 1 Dose | 2012-03-22T09:52 | PT1H30M | PT1H45M | |
9 | ABC-123 | CV | 101 | 9 | HR | Heart Rate | UNCONSTRAINED | 146 | beats/min | 146 | 146 | beats/min | Intravascular | CONSCIOUS | 2012-03-22 | 1 | 1 | 02:00:00 | 9 | PT2H | Day 1 Dose | 2012-03-22T09:52 | PT1H45M | PT2H |
Row | STUDYID | DOMAIN | USUBJID | CVSEQ | CVTESTCD | CVTEST | CVPOS | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVMETHOD | CVCSTATE | CVBLFL | CVDTC | CVDY | CVNOMDY | CVTPT | CVTPTNUM | CVELTM | CVTPTREF | CVRFTDTC | CVSTINT | CVENINT |
10 | ABC-123 | CV | 101 | 10 | HR | Heart Rate | UNCONSTRAINED | 166 | beats/min | 166 | 166 | beats/min | Intravascular | CONSCIOUS | 2012-03-22 | 1 | 1 | 03:00:00 | 10 | PT3H | Day 1 Dose | 2012-03-22T09:52 | PT2H | PT3H | |
11 | ABC-123 | CV | 101 | 11 | HR | Heart Rate | UNCONSTRAINED | 146 | beats/min | 146 | 146 | beats/min | Intravascular | CONSCIOUS | 2012-03-22 | 1 | 1 | 04:00:00 | 11 | PT4H | Day 1 Dose | 2012-03-22T09:52 | PT3H | PT4H | |
12 | ABC-123 | CV | 101 | 12 | HR | Heart Rate | UNCONSTRAINED | 149 | beats/min | 149 | 149 | beats/min | Intravascular | CONSCIOUS | 2012-03-22 | 1 | 1 | 05:00:00 | 12 | PT5H | Day 1 Dose | 2012-03-22T09:52 | PT4H | PT5H | |
13 | ABC-123 | CV | 101 | 13 | HR | Heart Rate | UNCONSTRAINED | 123 | beats/min | 123 | 123 | beats/min | Intravascular | CONSCIOUS | 2012-03-22 | 1 | 1 | 06:00:00 | 13 | PT6H | Day 1 Dose | 2012-03-22T09:52 | PT5H | PT6H | |
14 | ABC-123 | CV | 101 | 14 | HR | Heart Rate | UNCONSTRAINED | 105 | beats/min | 105 | 105 | beats/min | Intravascular | CONSCIOUS | 2012-03-22 | 1 | 1 | 08:00:00 | 14 | PT8H | Day 1 Dose | 2012-03-22T09:52 | PT6H | PT8H | |
15 | ABC-123 | CV | 101 | 15 | HR | Heart Rate | UNCONSTRAINED | 100 | beats/min | 100 | 100 | beats/min | Intravascular | CONSCIOUS | 2012-03-22 | 1 | 1 | 10:00:00 | 15 | PT10H | Day 1 Dose | 2012-03-22T09:52 | PT8H | PT10H | |
16 | ABC-123 | CV | 101 | 16 | HR | Heart Rate | UNCONSTRAINED | 113 | beats/min | 113 | 113 | beats/min | Intravascular | CONSCIOUS | 2012-03-22 | 1 | 1 | 12:00:00 | 16 | PT12H | Day 1 Dose | 2012-03-22T09:52 | PT10H | PT12H |
Respiratory Test Results – RE
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
DOMAIN | Domain Abbreviation | Char | RE | Identifier | Two-character abbreviation for the domain. | Req |
USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify a subject across all studies for all application or submissions involving the product. | Req | |
RESEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | |
REGRPID | Group Identifier | Char | Identifier | Used to tie together a block of related records in a single domain for a subject and can be used to support relationships within the domain and between domains using RELREC. This is not the treatment group number. | Perm | |
RESPID | Sponsor-Defined Identifier | Char | Identifier | Sponsor-defined reference identifier. | Perm | |
RETESTCD | Test Short Name | Char | Topic | Short name of the measurement, test, or examination described in RETEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in RETESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). RETESTCD cannot contain characters other than letters, numbers, or underscores. Examples: RESPRATE, TIDALVOL, MV. | Req | |
RETEST | Test Name | Char | Synonym Qualifier | Long name for RETESTCD. The value in RETEST cannot be longer than 40 characters. Examples: Respiratory Rate, Tidal Volume, Minute Volume. | Req | |
REPOS | Position of Subject During Test | Char | Record Qualifier | Position of the subject during the measurement or examination, If the subject is restrained, populate with the position (example SITTING or STANDING); otherwise, populate with UNCONSTRAINED. | Exp | |
REORRES | Result or Findings as Collected | Char | Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp | |
REORRESU | Unit of the Original Result | Char | Variable Qualifier | The unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology (http://www.cdisc.org/terminology) list. | Exp | |
RESTRESC | Standardized Result in Character Format | Char | Result Qualifier | Contains the result value for all findings, copied or derived from REORRES in a standard format or standard units. RESTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in RESTRESN. | Exp | |
RESTRESN | Standardized Result in Numeric Format | Num | Result Qualifier | Used for continuous or numeric results or findings in standard format; contains the numeric form of RESTRESC. RESTRESN should store all numeric test results or findings. | Exp | |
RESTRESU | Unit of the Standardized Result | Char | Variable Qualifier | Standardized unit used for RESTRESC and RESTRESN. | Exp | |
RESTAT | Completion Status | Char | Record Qualifier | Used to indicate when a test is not done or result is missing. Should be null if a result exists in REORRES. | Perm |
REREASND | Reason Not Done | Char | Record Qualifier | Describes why RESTAT is NOT DONE, such as BROKEN EQUIPMENT. | Perm | |
REMETHOD | Method of Test | Char | Record Qualifier | Method of the test or examination. Examples: Whole body plethysmograph, Head-out plethysmograph, Invasive. | Exp | |
RECSTATE | Consciousness State | Char | Record Qualifier | Consciousness state of the subject at the time of measurement. Examples: CONSCIOUS, SEMI- CONSCIOUS, UNCONSCIOUS | Exp | |
REBLFL | Baseline Flag | Char | Record Qualifier | A baseline indicator may be used to calculate differences or changes from baseline. Value should be Y or null. The baseline flag is sponsor defined. | Exp | |
REDRVFL | Derived Flag | Char | Record Qualifier | Used to indicate a derived record. The value should be Y or null. | Perm | |
REEXCLFL | Exclusion Flag | Char | Record Qualifier | Y if the result should be excluded from all calculations, otherwise null. | Perm | |
REREASEX | Reason for Exclusion | Char | Record Qualifier | The reason the result should be excluded from all calculations. Used only when REEXCLFL is Y. | Perm | |
REUSCHFL | Unscheduled Flag | Char | Record Qualifier | Indicates whether the timing of the performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null. | Perm | |
REDTC | Date/Time of Respiratory Measurement | Char | ISO 8601 | Timing | Date/Time of respiratory data collection, in ISO 8601 format. For measurements related to a continuous evaluation interval, REDTC should be used to indicate the start date/time of that interval. | Exp |
REENDTC | End Date/Time of Respiratory Measurement | Char | ISO 8601 | Timing | Date/Time of end of the respiratory evaluation interval, in ISO 8601 format. Should be populated when REDTC represents the start date/time of a continuous evaluation interval. | Perm |
REDY | Study Day of Respiratory Measurement | Num | Timing | Study day of respiratory data collection, in integer days. For measurements related to a continuous evaluation interval, REDY can be used to indicate start day of that interval. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | |
REENDY | End Study Day of Respiratory Measurement | Num | Timing | Study day of the respiratory data collection, in integer days. Can be populated when REDY represents the start day of a continuous evaluation interval. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain. | Perm | |
RENOMDY | Nominal Study Day for Tabulations | Num | Timing | Nominal study day used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer. | Exp | |
RENOMLBL | Label for Nominal Study Day | Char | Timing | A label for a given value of RENOMDY as presented in the study report. Examples: Pretreatment, Week 4, Day 28. | Perm | |
RETPT | Planned Time Point Name | Char | Timing | Text description of time when respiratory data should be collected. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See RETPTNUM and RETPTREF. Examples: Predose, 1 Hour Postdose. | Exp | |
RETPTNUM | Planned Time Point Number | Num | Timing | Numerical version of RETPT to aid in sorting. | Exp | |
REELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 | Timing | Planned elapsed time (in ISO 8601 format) relative to a fixed time point reference (RETPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as an ISO 8601 duration. Examples: "-PT15M" to represent the period of 15 minutes prior to the reference point indicated by RETPTREF, or "PT8H" to represent the period of 8 hours after the reference point indicated by RETPTREF. | Exp |
RETPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by REELTM, if used for RETPTNUM, and RETPT. It is recommended that RETPTREF be as descriptive as possible so the reference time point can be inferred without looking at others variables. Example: DAY 1 FIRST DOSE. | Exp | |
RERFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 | Timing | Date/Time of the reference time point, RETPTREF. | Perm |
REEVLINT | Evaluation Interval | Char | ISO 8601 | Timing | Length of evaluation interval in ISO 8601 duration format. Used in place of RESTINT and REENINT when RETPTREF is not available. | Perm |
RESTINT | Planned Start of Assessment Interval | Char | ISO 8601 | Timing | Planned start of an assessment interval relative to Time Point Reference (RETPTREF) in ISO 8601 duration format. Example: When the evaluation interval is from 1 to 2 hours after dosing, the value would be PT1H. | Exp |
REENINT | Planned End of Assessment Interval | Char | ISO 8601 | Timing | Planned end of an assessment interval relative to Time Point Reference (RETPTREF) in ISO 8601 duration format. Example: When the evaluation interval is from 1 to 2 hours after dosing, the value would be PT2H. | Exp |
Assumptions for Respiratory Test Results (RE) Domain Model
The RE domain contains dynamic measurements, collected or derived, related to the respiratory system.
The actual timing variables REDTC, REENDTC, REDY and REENDY are used to represent the start and end of the evaluation period during which data that contributed to the reported result were collected. This may be a portion of a longer period over which the instrument was continuously collecting data.
RESTINT and REENINT should be used to describe a known assessment interval whenever there is a reference time point (RETPTREF).
REMETHOD and RECSTATE are considered important for comparison purposes and should be populated whenever available or collected.
Examples for Respiratory Test Results (RE) Domain Model
The Cardiovascular Test Results (CV), ECG Results (EG), and RE domains are very similar in structure. Note that the examples provided in this section represent uses of timing variables, which could apply to any of these domains, regardless of study type or design.
Example 1
This example shows measurements for 2 animals. At each time point (baseline, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours), the previous 15 minutes of data are aggregated to represent a result.
-PT30M to -PT15M) are aggregated.
re.xpt
Row | STUDYID | DOMAIN | USUBJID | RESEQ | RETESTCD | RETEST | REPOS | REORRES | REORRESU | RESTRESC | RESTRESN | RESTRESU | REMETHOD | RECSTATE | REBLFL | REDTC | REDY | RENOMDY | RETPT | RETPTNUM | REELTM | RETPTREF | RERFTDTC | RESTINT | REENINT |
1 | AA1111 | RE | AA111-3 | 1 | RESPRATE | Respiratory Rate | SITTING | 115.25 | breaths/min | 115.25 | 115.25 | breaths/min | plethysmograph | CONSCIOUS | Y | 2005-12-15 | 1 | 1 | baseline | 0 | -PT15M | Day 1 Dose | 2005-12-15T10:00 | -PT30M | -PT15M |
2 | AA1111 | RE | AA111-3 | 2 | RESPRATE | Respiratory Rate | SITTING | 127.11 | breaths/min | 127.11 | 127.11 | breaths/min | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 30 Minutes | 2 | PT30M | Day 1 Dose | 2005-12-15T10:00 | P15M | PT30M | |
3 | AA1111 | RE | AA111-3 | 3 | RESPRATE | Respiratory Rate | SITTING | 111.57 | breaths/min | 111.57 | 111.57 | breaths/min | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 60 Minutes | 4 | PT60M | Day 1 Dose | 2005-12-15T10:00 | P45M | PT60M | |
4 | AA1111 | RE | AA111-3 | 4 | RESPRATE | Respiratory Rate | SITTING | 140.28 | breaths/min | 140.28 | 140.28 | breaths/min | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 90 Minutes | 6 | PT90M | Day 1 Dose | 2005-12-15T10:00 | P75M | PT90M | |
5 | AA1111 | RE | AA111-3 | 5 | RESPRATE | Respiratory Rate | SITTING | 109.87 | breaths/min | 109.87 | 109.87 | breaths/min | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 2 Hours | 8 | PT2H | Day 1 Dose | 2005-12-15T10:00 | P105M | PT2H | |
6 | AA1111 | RE | AA111-3 | 6 | RESPRATE | Respiratory Rate | SITTING | 85.84 | breaths/min | 85.84 | 85.84 | breaths/min | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 4 Hours | 16 | PT4H | Day 1 Dose | 2005-12-15T10:00 | P225M | PT4H | |
7 | AA1111 | RE | AA111-3 | 7 | TIDALVOL | Tidal Volume | SITTING | 1.48 | mL | 1.48 | 1.48 | mL | plethysmograph | CONSCIOUS | Y | 2005-12-15 | 1 | 1 | baseline | 0 | -PT15M | Day 1 Dose | 2005-12-15T10:00 | -PT30M | -PT15M |
8 | AA1111 | RE | AA111-3 | 8 | TIDALVOL | Tidal Volume | SITTING | 1.46 | mL | 1.46 | 1.46 | mL | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 30 Minutes | 2 | PT30M | Day 1 Dose | 2005-12-15T10:00 | P15M | PT30M | |
9 | AA1111 | RE | AA111-3 | 9 | TIDALVOL | Tidal Volume | SITTING | 1.34 | mL | 1.34 | 1.34 | mL | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 60 Minutes | 4 | PT60M | Day 1 Dose | 2005-12-15T10:00 | P45M | PT60M | |
10 | AA1111 | RE | AA111-3 | 10 | TIDALVOL | Tidal Volume | SITTING | 1.11 | mL | 1.11 | 1.11 | mL | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 90 Minutes | 6 | PT90M | Day 1 Dose | 2005-12-15T10:00 | P75M | PT90M | |
11 | AA1111 | RE | AA111-3 | 11 | TIDALVOL | Tidal Volume | SITTING | 1.29 | mL | 1.29 | 1.29 | mL | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 2 Hours | 8 | PT2H | Day 1 Dose | 2005-12-15T10:00 | P105M | PT2H | |
12 | AA1111 | RE | AA111-3 | 12 | TIDALVOL | Tidal Volume | SITTING | 1.58 | mL | 1.58 | 1.58 | mL | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 4 Hours | 16 | PT4H | Day 1 Dose | 2005-12-15T10:00 | P225M | PT4H | |
13 | AA1111 | RE | AA111-3 | 13 | MV | Minute Volume | SITTING | 170.43 | mL/min | 170.43 | 170.43 | mL/min | plethysmograph | CONSCIOUS | Y | 2005-12-15 | 1 | 1 | baseline | 0 | -PT15M | Day 1 Dose | 2005-12-15T10:00 | -PT30M | -PT15M |
14 | AA1111 | RE | AA111-3 | 14 | MV | Minute Volume | SITTING | 184.98 | mL/min | 184.98 | 184.98 | mL/min | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 30 Minutes | 2 | PT30M | Day 1 Dose | 2005-12-15T10:00 | P15M | PT30M | |
15 | AA1111 | RE | AA111-3 | 15 | MV | Minute Volume | SITTING | 149.27 | mL/min | 149.27 | 149.27 | mL/min | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 60 Minutes | 4 | PT60M | Day 1 Dose | 2005-12-15T10:00 | P45M | PT60M | |
16 | AA1111 | RE | AA111-3 | 16 | MV | Minute Volume | SITTING | 155.19 | mL/min | 155.19 | 155.19 | mL/min | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 90 Minutes | 6 | PT90M | Day 1 Dose | 2005-12-15T10:00 | P75M | PT90M | |
17 | AA1111 | RE | AA111-3 | 17 | MV | Minute Volume | SITTING | 141.95 | mL/min | 141.95 | 141.95 | mL/min | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 2 Hours | 8 | PT2H | Day 1 Dose | 2005-12-15T10:00 | P105M | PT2H | |
18 | AA1111 | RE | AA111-3 | 18 | MV | Minute Volume | SITTING | 135.34 | mL/min | 135.34 | 135.34 | mL/min | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 4 Hours | 16 | PT4H | Day 1 Dose | 2005-12-15T10:00 | P225M | PT4H | |
19 | AA1111 | RE | AA111-7 | 19 | RESPRATE | Respiratory Rate | SITTING | 123.06 | breaths/min | 123.06 | 123.06 | breaths/min | plethysmograph | CONSCIOUS | Y | 2005-12-15 | 1 | 1 | baseline | 0 | -PT15M | Day 1 Dose | 2005-12-15T10:00 | -PT30M | -PT15M |
20 | AA1111 | RE | AA111-7 | 20 | RESPRATE | Respiratory Rate | SITTING | 149.42 | breaths/min | 149.42 | 149.42 | breaths/min | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 30 Minutes | 2 | PT30M | Day 1 Dose | 2005-12-15T10:00 | P15M | PT30M | |
21 | AA1111 | RE | AA111-7 | 21 | RESPRATE | Respiratory Rate | SITTING | 122.17 | breaths/min | 122.17 | 122.17 | breaths/min | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 60 Minutes | 4 | PT60M | Day 1 Dose | 2005-12-15T10:00 | P45M | PT60M | |
22 | AA1111 | RE | AA111-7 | 22 | RESPRATE | Respiratory Rate | SITTING | 140.47 | breaths/min | 140.47 | 140.47 | breaths/min | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 90 Minutes | 6 | PT90M | Day 1 Dose | 2005-12-15T10:00 | P75M | PT90M | |
23 | AA1111 | RE | AA111-7 | 23 | RESPRATE | Respiratory Rate | SITTING | 117.75 | breaths/min | 117.75 | 117.75 | breaths/min | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 2 Hours | 8 | PT2H | Day 1 Dose | 2005-12-15T10:00 | P105M | PT2H | |
24 | AA1111 | RE | AA111-7 | 24 | RESPRATE | Respiratory Rate | SITTING | 116.00 | breaths/min | 116.00 | 116 | breaths/min | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 4 Hours | 16 | PT4H | Day 1 Dose | 2005-12-15T10:00 | P225M | PT4H | |
25 | AA1111 | RE | AA111-7 | 25 | TIDALVOL | Tidal Volume | SITTING | 1.24 | mL | 1.24 | 1.24 | mL | plethysmograph | CONSCIOUS | Y | 2005-12-15 | 1 | 1 | baseline | 0 | -PT15M | Day 1 Dose | 2005-12-15T10:00 | -PT30M | -PT15M |
26 | AA1111 | RE | AA111-7 | 26 | TIDALVOL | Tidal Volume | SITTING | 1.33 | mL | 1.33 | 1.33 | mL | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 30 Minutes | 2 | PT30M | Day 1 Dose | 2005-12-15T10:00 | P15M | PT30M | |
27 | AA1111 | RE | AA111-7 | 27 | TIDALVOL | Tidal Volume | SITTING | 1.45 | mL | 1.45 | 1.45 | mL | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 60 Minutes | 4 | PT60M | Day 1 Dose | 2005-12-15T10:00 | P45M | PT60M | |
28 | AA1111 | RE | AA111-7 | 28 | TIDALVOL | Tidal Volume | SITTING | 1.27 | mL | 1.27 | 1.27 | mL | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 90 Minutes | 6 | PT90M | Day 1 Dose | 2005-12-15T10:00 | P75M | PT90M | |
29 | AA1111 | RE | AA111-7 | 29 | TIDALVOL | Tidal Volume | SITTING | 1.42 | mL | 1.42 | 1.42 | mL | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 2 Hours | 8 | PT2H | Day 1 Dose | 2005-12-15T10:00 | P105M | PT2H | |
30 | AA1111 | RE | AA111-7 | 30 | TIDALVOL | Tidal Volume | SITTING | 1.50 | mL | 1.50 | 1.5 | mL | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 4 Hours | 16 | PT4H | Day 1 Dose | 2005-12-15T10:00 | P225M | PT4H | |
31 | AA1111 | RE | AA111-7 | 31 | MV | Minute Volume | SITTING | 153.09 | mL/min | 153.09 | 153.09 | mL/min | plethysmograph | CONSCIOUS | Y | 2005-12-15 | 1 | 1 | baseline | 0 | -PT15M | Day 1 Dose | 2005-12-15T10:00 | -PT30M | -PT15M |
32 | AA1111 | RE | AA111-7 | 32 | MV | Minute Volume | SITTING | 198.06 | mL/min | 198.06 | 198.06 | mL/min | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 30 Minutes | 2 | PT30M | Day 1 Dose | 2005-12-15T10:00 | P15M | PT30M | |
33 | AA1111 | RE | AA111-7 | 33 | MV | Minute Volume | SITTING | 176.67 | mL/min | 176.67 | 176.67 | mL/min | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 60 Minutes | 4 | PT60M | Day 1 Dose | 2005-12-15T10:00 | P45M | PT60M | |
34 | AA1111 | RE | AA111-7 | 34 | MV | Minute Volume | SITTING | 178.20 | mL/min | 178.20 | 178.2 | mL/min | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 90 Minutes | 6 | PT90M | Day 1 Dose | 2005-12-15T10:00 | P75M | PT90M | |
35 | AA1111 | RE | AA111-7 | 35 | MV | Minute Volume | SITTING | 167.47 | mL/min | 167.47 | 167.47 | mL/min | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 2 Hours | 8 | PT2H | Day 1 Dose | 2005-12-15T10:00 | P105M | PT2H | |
36 | AA1111 | RE | AA111-7 | 36 | MV | Minute Volume | SITTING | 174.18 | mL/min | 174.18 | 174.18 | mL/min | plethysmograph | CONSCIOUS | 2005-12-15 | 1 | 1 | 4 Hours | 16 | PT4H | Day 1 Dose | 2005-12-15T10:00 | P225M | PT4H |
Example 2
This example shows measurements for 2 animals with continuous collection summarized into 1-hour measurements. The protocol defines the individual time points as the start of the assessment interval relative to the dosing. The REELTM shows the start of the planned assessment interval relative to the RETPTREF (day 1 dose).
re.xpt
Row | STUDYID | DOMAIN | USUBJID | RESEQ | RETESTCD | RETEST | REPOS | REORRES | REORRESU | RESTRESC | RESTRESN | RESTRESU | REMETHOD | RECSTATE | REBLFL | REDTC | REDY | RENOMDY | RETPT | RETPTNUM | REELTM | RETPTREF | RERFTDTC | RESTINT | REENINT |
1 | XY123 | RE | XY123_101 | 1 | RESPRATE | Respiratory Rate | UNCONSTRAINED | 115.25 | breaths/min | 115.25 | 115.25 | breaths/min | plethysmograph | CONSCIOUS | Y | 2010-04- 06 | 1 | 1 | Predose | 0 | -PT1H | Day 1 Dose | 2010-04- 06T11:32:58 | -PT1H | PT0H |
2 | XY123 | RE | XY123_101 | 2 | RESPRATE | Respiratory Rate | UNCONSTRAINED | 127.11 | breaths/min | 127.11 | 127.11 | breaths/min | plethysmograph | CONSCIOUS | 2010-04- 06 | 1 | 1 | 0 Hour | 1 | PT0H | Day 1 Dose | 2010-04- 06T11:32:58 | PT0H | PT1H | |
3 | XY123 | RE | XY123_101 | 3 | RESPRATE | Respiratory Rate | UNCONSTRAINED | 111.57 | breaths/min | 111.57 | 111.57 | breaths/min | plethysmograph | CONSCIOUS | 2010-04- 06 | 1 | 1 | 1 Hour | 2 | PT1H | Day 1 Dose | 2010-04- 06T11:32:58 | PT1H | PT2H | |
4 | XY123 | RE | XY123_101 | 4 | TIDALVOL | Tidal Volume | UNCONSTRAINED | 1.48 | mL | 1.48 | 1.48 | mL | plethysmograph | CONSCIOUS | Y | 2010-04- 06 | 1 | 1 | Predose | 0 | -PT1H | Day 1 Dose | 2010-04- 06T11:32:58 | -PT1H | PT0H |
5 | XY123 | RE | XY123_101 | 5 | TIDALVOL | Tidal Volume | UNCONSTRAINED | 1.46 | mL | 1.46 | 1.46 | mL | plethysmograph | CONSCIOUS | 2010-04- 06 | 1 | 1 | 0 Hour | 1 | PT0H | Day 1 Dose | 2010-04- 06T11:32:58 | PT0H | PT1H | |
6 | XY123 | RE | XY123_101 | 6 | TIDALVOL | Tidal Volume | UNCONSTRAINED | 1.34 | mL | 1.34 | 1.34 | mL | plethysmograph | CONSCIOUS | 2010-04- 06 | 1 | 1 | 1 Hour | 2 | PT1H | Day 1 Dose | 2010-04- 06T11:32:58 | PT1H | PT2H | |
7 | XY123 | RE | XY123_101 | 7 | MV | Minute Volume | UNCONSTRAINED | 170.43 | mL/min | 170.43 | 170.43 | mL/min | plethysmograph | CONSCIOUS | Y | 2010-04- 06 | 1 | 1 | Predose | 0 | -PT1H | Day 1 Dose | 2010-04- 06T11:32:58 | -PT1H | PT0H |
8 | XY123 | RE | XY123_101 | 8 | MV | Minute Volume | UNCONSTRAINED | 184.98 | mL/min | 184.98 | 184.98 | mL/min | plethysmograph | CONSCIOUS | 2010-04- 06 | 1 | 1 | 0 Hour | 1 | PT0H | Day 1 Dose | 2010-04- 06T11:32:58 | PT0H | PT1H | |
9 | XY123 | RE | XY123_101 | 9 | MV | Minute Volume | UNCONSTRAINED | 149.27 | mL/min | 149.27 | 149.27 | mL/min | plethysmograph | CONSCIOUS | 2010-04- 06 | 1 | 1 | 1 Hour | 2 | PT1H | Day 1 Dose | 2010-04- 06T11:32:58 | PT1H | PT2H | |
10 | XY123 | RE | XY123_102 | 10 | RESPRATE | Respiratory Rate | UNCONSTRAINED | 123.06 | breaths/min | 123.06 | 123.06 | breaths/min | plethysmograph | CONSCIOUS | Y | 2010-04- 06 | 1 | 1 | Predose | 0 | -PT1H | Day 1 Dose | 2010-04- 06T11:33:02 | -PT1H | PT0H |
11 | XY123 | RE | XY123_102 | 11 | RESPRATE | Respiratory Rate | UNCONSTRAINED | 149.42 | breaths/min | 149.42 | 149.42 | breaths/min | plethysmograph | CONSCIOUS | 2010-04- 06 | 1 | 1 | 0 Hour | 1 | PT0H | Day 1 Dose | 2010-04- 06T11:33:02 | PT0H | PT1H | |
12 | XY123 | RE | XY123_102 | 12 | RESPRATE | Respiratory Rate | UNCONSTRAINED | 122.17 | breaths/min | 122.17 | 122.17 | breaths/min | plethysmograph | CONSCIOUS | 2010-04- 06 | 1 | 1 | 1 Hour | 2 | PT1H | Day 1 Dose | 2010-04- 06T11:33:02 | PT1H | PT2H | |
13 | XY123 | RE | XY123_102 | 13 | TIDALVOL | Tidal Volume | UNCONSTRAINED | 1.24 | mL | 1.24 | 1.24 | mL | plethysmograph | CONSCIOUS | Y | 2010-04- 06 | 1 | 1 | Predose | 0 | -PT1H | Day 1 Dose | 2010-04- 06T11:33:02 | -PT1H | PT0H |
14 | XY123 | RE | XY123_102 | 14 | TIDALVOL | Tidal Volume | UNCONSTRAINED | 1.33 | mL | 1.33 | 1.33 | mL | plethysmograph | CONSCIOUS | 2010-04- 06 | 1 | 1 | 0 Hour | 1 | PT0H | Day 1 Dose | 2010-04- 06T11:33:02 | PT0H | PT1H | |
15 | XY123 | RE | XY123_102 | 15 | TIDALVOL | Tidal Volume | UNCONSTRAINED | 1.45 | mL | 1.45 | 1.45 | mL | plethysmograph | CONSCIOUS | 2010-04- 06 | 1 | 1 | 1 Hour | 2 | PT1H | Day 1 Dose | 2010-04- 06T11:33:02 | PT1H | PT2H | |
16 | XY123 | RE | XY123_102 | 16 | MV | Minute Volume | UNCONSTRAINED | 153.09 | mL/min | 153.09 | 153.09 | mL/min | plethysmograph | CONSCIOUS | Y | 2010-04- 06 | 1 | 1 | Predose | 0 | -PT1H | Day 1 Dose | 2010-04- 06T11:33:02 | -PT1H | PT0H |
17 | XY123 | RE | XY123_102 | 17 | MV | Minute Volume | UNCONSTRAINED | 198.06 | mL/min | 198.06 | 198.06 | mL/min | plethysmograph | CONSCIOUS | 2010-04- 06 | 1 | 1 | 0 Hour | 1 | PT0H | Day 1 Dose | 2010-04- 06T11:33:02 | PT0H | PT1H | |
18 | XY123 | RE | XY123_102 | 18 | MV | Minute Volume | UNCONSTRAINED | 176.67 | mL/min | 176.67 | 176.67 | mL/min | plethysmograph | CONSCIOUS | 2010-04- 06 | 1 | 1 | 1 Hour | 2 | PT1H | Day 1 Dose | 2010-04- 06T11:33:02 | PT1H | PT2H |
Introduction to Trial Design Model Datasets
Purpose of Trial Design Model
The Trial Design Model in the SENDIG provides a standardized way to describe those aspects of the planned conduct of a nonclinical study, as shown in the study design diagram examples within this section. The Trial Design Model in the SENDIG is equivalent to the Trial Design Model within the SDTMIG for clinical trials. Trial Design datasets contain study-level, rather than subject-level, information. Note that generally the term "trial" is equivalent to "study" in the nonclinical context. In addition, "subjects" are equivalent to "animals."
The Trial Design datasets will allow:
Clear and quick understanding of the design of nonclinical studies (or trials)
Comparison of the designs of different studies (or trials)
Comparison of planned and actual treatments and sponsor-defined groups for subjects (or animals) in a study (or trial)
Modeling a nonclinical study in this standardized way requires the explicit statement of certain decision rules that may not be addressed or may not be as explicit in the textual description of the approved study protocol (or study plan). Prospective modeling of the design of a study could contribute to a more complete and wholly representative protocol. Retrospective modeling of the study design provides a reviewer with a clear description of how the study was conducted.
Definitions of Trial Design Concepts
A nonclinical study is a scientific experiment, typically involving animal subjects, which is intended to address certain scientific questions that are the objectives of the study.
Branch | In a study with multiple arms, the protocol plans for each subject to be assigned to 1 arm. The time within the study at which this assignment takes place is often the point at which arms with common elements diverge into uncommon or nonshared elements, and is referred to as a "branch point." Many studies have a single branch point. Subjects are assigned to an arm all at the same time. For other studies, there may be 2 or more branches that collectively assign a subject to individual arms. The process that makes this assignment may be a randomization, but this is not always the case, as branch points are protocol-defined. |
Element | An element is a basic building block in the study design. All elements are related to the administration of planned interventions, which may involve treatment or no treatment, during a period of time. Elements for which the planned intervention does not involve treatment would include screening, wash-out, and recovery. |
Epoch | As part of the design of a study, the planned periods or phases of subjects' participation in the study are divided into epochs. Each epoch is a period of time that serves a purpose in the study as a whole. Typically, the purpose of an epoch will be to expose subjects to a treatment, or to prepare for such a treatment period (e.g., pretreatment or screening period, wash-out previous treatments) or to gather data on subjects after a treatment has ended (e.g., recovery phase). It is possible for epochs to span multiple elements for some or all trial arms present on a study. For example, there may be 2 sequential (but different) treatment elements planned for a group; the sponsor might choose to include both of these in a single treatment epoch. |
Treatment | The word "treatment" may be used in connection with epochs or elements, but has somewhat different meanings in each context: element treatment might specify twice-daily dosing of 100-mg/kg doses of compound X. In this case, ELEMENT may be populated as "Study Drug 100 mg/kg Administered Twice Daily". |
Because epochs cut across arms, an epoch involving treatment is a higher-level concept that may not specify anything that differs between arms. For example, in a 3-period crossover study of 3 doses of compound X, each treatment epoch is associated with compound X, but not with a specific dose. In this case, EPOCH may be populated as "Study Treatment".
An element may be fairly detailed. For example, for an element representing repeated dosing, an
Trial arm | A trial arm is a planned path through the study based upon a planned sequence of elements. This path covers the entire time of the study. Each sponsor-defined protocol group may contain subjects from several arms, 1 arm, or part of an arm. Each subject is assigned to 1 and only 1 planned arm. |
Trial design | The design of a study is a plan outlining the activities subjects will experience and what data will be collected during the course of the study in order to address the study's objectives. |
Trial group | A "group" describes the sponsor-defined protocol structure commonly used in nonclinical studies, where study subjects are allocated to study groups within the study protocol. These groups may be defined for a variety of experimental purposes. Groups are frequently defined to separate subjects receiving different treatments, but there may be other considerations involved in the design of any particular study. For purposes of SEND, a trial group is a collection of subjects which have been designated with the same sponsor-defined protocol group code. A trial group consists of 1 or more trial sets. |
Trial set | A trial set is a collection of subjects that have a common set of parameters defined in the protocol, where those parameters include experimental parameters (e.g., diet restriction), treatment parameters, and/or sponsor-defined attributes (e.g., control-group designation). There should be no planned parameters of interest that could further subdivide a trial set. Each subject must be assigned to 1 and only 1 trial set. Each trial set should be assigned to a single group. Each set should be assigned to a single trial arm. |
Trial summary | As part of the Trial Design datasets, trial summary provides important or key study-level information. |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
DOMAIN | Domain Abbreviation | Char | TE | Identifier | Two-character abbreviation for the domain. | Req |
ETCD | Element Code | Char | Topic | ETCD (the short form of ELEMENT) is limited to 8 characters and does not have special character restrictions. | Req | |
ELEMENT | Description of Element | Char | Synonym Qualifier | The name of the Element. | Req | |
TESTRL | Rule for Start of Element | Char | Rule | Expresses rule for beginning Element. | Req | |
TEENRL | Rule for End of Element | Char | Rule | Expresses rule for ending Element. Either TEENRL or TEDUR must be present for each Element; both may be present. | Perm | |
TEDUR | Planned Duration of Element | Char | ISO 8601 | Timing | Planned duration of Element in ISO 8601 format. Use when an Element represents a fixed duration. TEENRL or TEDUR must be present for each Element; both may be present. | Perm |
Assumptions for Trial Elements (TE) Domain Model
Trial elements are the building blocks of arms. Arms consisting of elements are the paths that subjects will follow throughout a trial. All elements are related to study treatment. Therefore, an element is defined by the treatment (or lack of treatment) to be administered to subjects during the element, as well as either the planned duration or start/end rules of the element.
Elements with different start and end rules are different elements and must be represented as unique values in ELEMENT and ETCD (i.e., elements involving the same treatment but different durations are different elements). The same applies to nontreatment elements (e.g., a wash-out with a fixed duration of 14 days is different from a wash-out that ends after 7 days if drug cannot be detected in a blood sample or after 14 days if drug can be detected in a blood sample).
ELEMENT and ETCD values in TE, Subject Elements (SE), and Trial Arms (TA) must coincide (ELEMENT and ETCD are defined as the planned trial elements in TE, and the planned elements are then applied to subjects in SE and to arms in TA).
Additional factors beyond treatment, start rule, and either end rule or duration do not distinguish separate elements. For example, a restricted vs. ad libitum diet for the same treatment does not necessarily imply different treatment elements for the subjects experiencing these conditions, even though the subjects may be analyzed differently or be assigned to different groups or trial sets.
Elements often appear in more than one arm or epoch and can be reused within the same arm or epoch and across arms and epochs. Therefore, it is not recommended that the values of ETCD and ELEMENT refer to arms or epochs.
There are no gaps between elements. The instant one element ends, the next element begins. A subject spends no time "between" elements.
The ELEMENT variable contains the description of the element and often indicates the treatment being administered during an element. If no treatment is administered, as is often the case with a screening element, the other activities that define this period of time (as related to a treatment element) become the value of ELEMENT (e.g., "Screening," "Recovery," "Washout," where screening, recovery, and wash-out all take place within the context of the treatment element).
For treatment elements, the ELEMENT variable may include the following information (if appropriate for the element): treatment amount; treatment frequency; and total daily dose, if different from treatment amount.
TESTRL is the rule that defines the start of element. TESTRL identifies the event that marks the transition into an element. For elements that involve treatment, TESTRL is usually populated with a value that indicates treatment administration.
The start of the study for a particular arm is defined by the value of TESTRL for the first element within that arm.
TESTRL for a treatment element may be thought of as active while the start rule for a nontreatment element, particularly a recovery or wash-out element, may be passive. The start of a treatment element will not occur until a dose is given, no matter how long that dose is delayed. Note that the date/time of the event that starts an element, which is described in TESTRL, will be used to populate the SESTDTC date/times in the SE dataset. Therefore, TESTRL should refer to an event of that the date/time will be captured during the course of the study.
TESTRL and TEENRL should be expressed without referring to arm or epoch.
TEENRL describes the circumstances under which an element ends, causing subjects to enter into another element. Element end rules may depend on a variety of conditions. The TA dataset, not the TE dataset, describes where the subject moves next; therefore, TEENRL values must be expressed independently of arms.
For elements that do not involve treatment, TESTRL can be more difficult to define. For wash-out and recovery elements, which often follow treatment elements, the start of the element may be defined relative to the end of a preceding treatment. For example, a wash-out period might be defined as starting after the last dose of drug for the preceding treatment element. This type of definition will place constraints on how the element can be sequenced within the TA dataset.
Defining a clear starting point for the start of a nontreatment element that always follows another nontreatment element can be particularly difficult. The transition may be defined by a decision-making activity such as randomization. For example, every arm of a study that involves treating disease episodes might start with a screening element followed by an element that consists of waiting until a disease episode occurs after an initial randomization of subjects. The activity that marks the beginning of the wait
element might then be the randomization.
Examples for Trial Elements (TE) Domain Model
Example 1: Simple Parallel Design
This is a simple study design example, including element start (TESTRL) and end (TEENRL) rules as well as element duration (TEDUR).
te.xpt
Row | STUDYID | DOMAIN | ETCD | ELEMENT | TESTRL | TEENRL | TEDUR |
1 | EXP1 | TE | SCRN | Screen | Start of Pretreatment | 1 week after start of Element | P7D |
2 | EXP1 | TE | TRT01 | Vehicle Control | First day of dosing with vehicle control | 28 days after start of Element | P28D |
3 | EXP1 | TE | TRT02 | 100 mg/kg Drug A, once daily | First day of dosing with 100 mg/kg Drug A | 28 days after start of Element | P28D |
4 | EXP1 | TE | TRT03 | 500 mg/kg Drug A, once daily | First day of dosing with 500 mg/kg Drug A | 28 days after start of Element | P28D |
Example 2: Study with a Nonfixed Duration Element
This example includes the nonfixed duration for pretest phase where the end rule is not a definite time, but when the subject achieves a specified body weight. In order to completely understand the experimental design of a trial, the TA and TS datasets are needed (see Section 7.3, Trial Arms, and Section 7.4, Trial Sets).
te.xpt
Row | STUDYID | DOMAIN | ETCD | ELEMENT | TESTRL | TEENRL | TEDUR |
1 | EXP7 | TE | PRETEST | Pretreatment Feeding Period | Start of pretreatment period | When subject's body weight is at least 750 g | |
2 | EXP7 | TE | CONTROL | Control Period | After completion of PRETEST Element | 30 days after start of Element | P30D |
3 | EXP7 | TE | TREAT2 | 100 mg/kg Drug A, once daily | After completion of PRETEST Element | 30 days after start of Element | P30D |
4 | EXP7 | TE | TREAT3 | 200 mg/kg Drug A, once daily | After completion of PRETEST Element | 30 days after start of Element | P30D |
5 | EXP7 | TE | TREAT4 | 300 mg/kg Drug A, once daily | After completion of PRETEST Element | 30 days after start of Element | P30D |
6 | EXP7 | TE | TREAT5 | 100 mg/kg Drug B, twice daily doses of 50 mg/kg each | After completion of PRETEST Element | 30 days after start of Element | P30D |
7 | EXP7 | TE | TREAT6 | 200 mg/kg Drug B, twice daily doses of 100 mg/kg each | After completion of PRETEST Element | 30 days after start of Element | P30D |
8 | EXP7 | TE | TREAT7 | 400 mg/kg Drug B, twice daily doses of 200 mg/kg each | After completion of PRETEST Element | 30 days after start of Element | P30D |
9 | EXP7 | TE | RECOVERY | Recovery Period | After last dose with treatment or vehicle control | 14 days after start of Element | P14D |
See also Section 7.5, Additional Examples of Trial Elements, Trial Arms, and Trial Sets.
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
DOMAIN | Domain Abbreviation | Char | TA | Identifier | Two-character abbreviation for the domain. | Req |
ARMCD | Planned Arm Code | Char | Topic | Short name of a specific ARM (may be up to 20 characters) used for sorting and programming. Should be populated in Demographics when Arms have been defined in this domain. | Req | |
ARM | Description of Planned Arm | Char | Synonym Qualifier | Descriptive name given to a specific Trial Arm (e.g., Low Dose, Mid Dose, 10 mg/kg/day dose). | Req |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
TAETORD | Order of Element within Arm | Num | Timing | Number that provides the order of the planned Element within the Arm. This value should be an integer. | Req | |
ETCD | Element Code | Char | Record Qualifier | ETCD (the companion to ELEMENT) is limited to 8 characters and does not have special character restrictions. | Req | |
ELEMENT | Description of Element | Char | Synonym Qualifier | The name of the Element. | Perm | |
TABRANCH | Branch | Char | Rule | Conditions subjects meet, occurring at the end of an Element, which cause an Arm to branch off from other Arms (e.g., randomization to control group). | Perm | |
TATRANS | Transition Rule | Char | Rule | If the study design allows for a subject to transition to an Element other than the next sequential Element, as defined by TAETORD, then the conditions for transitioning to those other Elements, as well as the alternative Element sequences, are specified in this rule (e.g., TATRANS = 'Subject with Hypoactivity Transitions to Rest Period to Treatment 2'). | Perm | |
EPOCH | Trial Epoch | Char | Timing | Name of the study Epoch with which this Element of the Arm is associated (e.g., Treatment, Screen). Equivalent to 'Phase' or 'Period.' | Exp |
Assumptions for Trial Arms (TA) Domain Model
The Trial Arms (TA) dataset provides a record of the complete planned sequence of elements for each arm.
ARM and ARMCD values in Demographics (DM) and TA must coincide (ARM and ARMCD are defined as the planned trial arms in TA, and the planned arms are then applied to subjects in DM).
TAETORD is an integer and is used to order the elements within an arm. In general the value of TAETORD is "1" for the first element in each arm, "2" for the second element in each arm, and so on. Occasionally, the sequential order of the elements may not be known in advance, in which case the TA domain is populated after the study has been conducted (e.g., for an unknown number of cycles of treatment and recovery in a group). Although the values of TAETORD need not always be consecutive, the values must always be populated according to the correct order of the elements within an arm, with the first element equivalent to the lowest value of TAETORD and the last element equivalent to the highest value of TAETORD.
The values of ETCD used in the TA dataset must match values for the same element in the Trial Elements (TE) dataset.
The elements in each arm must be consecutive in time; it is not correct to leave any gaps in time between elements. If a multiday pause in treatment is part of the study design, that should either be reflected within one of the existing element definitions, or a new element representing the lack of treatment should be included.
Elements in different arms with the same value of TAETORD may or may not happen at the same time, depending on the design of the study.
The same element may occur more than once within an arm.
TABRANCH describes the outcome of a branch decision point in the trial design for subjects in the arm. A branch decision point takes place between epochs and is associated with the element end, at which point the branching decision is made. For instance, if subjects are assigned to an arm where they receive treatment a through a randomization at the end of element X, the value of TABRANCH for element X would be "Randomized to A".
Branch decision points may be based on decision processes other than randomizations, such as clinical evaluations of disease response.
There is usually some gap in time between the performance of a randomization and the start of randomized treatment. However, in many studies this gap in time is small and it is not intended that subjects will leave the study between randomization and treatment. In these circumstances, the study does not need to be modeled with this time period between randomization and start of treatment as a separate element.
TATRANS describes the decision points that may lead to a shortened path within an arm (e.g. if some elements within the arm are skipped). If an element does not end with a decision that could lead to a shortened path within the arm, then TATRANS will be null. If there is a decision being represented within the value of TATRANS, the TATRANS rule should be populated as an "if-then" statement (e.g., "If condition X is true, then go to element with TAETORD = Z").
EPOCH is the conceptual basis for comparisons between arms. EPOCH is not strictly necessary for describing the sequence of elements in an arm path. The values of EPOCH should provide a description of a time period that is independent of the value of ARM.
EPOCH should be assigned in such a way that elements from different arms with the same value of EPOCH are comparable in some sense (e.g., EPOCH="Treatment", where specific treatments may be different across arms but the subjects are all being treated in some manner).
Example for Trial Arms (TA) Domain Model
Example 1: Simple Parallel Design, No Recovery
This example assumes a simple parallel design in which the sponsor-defined protocol specifies the following information. All subjects are to be screened for 7 days prior to randomization into 3 protocol groups:
Group 1 is a control group of 20 subjects, 10 male and 10 female, dosed with vehicle once per day for 28 days.
Group 2 is a low-dose group of 20 subjects, 10 male and 10 female, dosed at 100 mg/kg once per day for 28 days.
Group 3 is a high-dose group of 20 subjects, 10 male and 10 female, dosed at 500 mg/kg once per day for 28 days.
There are no other experimental factors of interest specified in the study design. This example corresponds to TE Example 1 (see Section 7.2.1.2, Examples for Trial Elements (TE) Domain Model) and TS Example 1 (Section 7.4.1.2, Example for Trial Sets (TX) Domain Model). In this case, the design consists of 3 trial arms, because there are 3 distinct sequences of elements, depicted as follows.
ta.xpt
Row | STUDYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT | TABRANCH | EPOCH |
1 | EXP1 | TA | 1 | Control | 1 | SCRN | Screen | Randomized to Group 1 | Screen |
2 | EXP1 | TA | 1 | Control | 2 | TRT01 | Vehicle Control | Treatment | |
3 | EXP1 | TA | 2 | 100 mg/kg | 1 | SCRN | Screen | Randomized to Group 2 | Screen |
4 | EXP1 | TA | 2 | 100 mg/kg | 2 | TRT02 | 100 mg/kg Drug A | Treatment | |
5 | EXP1 | TA | 3 | 500 mg/kg | 1 | SCRN | Screen | Randomized to Group 3 | Screen |
6 | EXP1 | TA | 3 | 500 mg/kg | 2 | TRT03 | 500 mg/kg Drug A | Treatment |
See also Section 7.5, Additional Examples of Trial Elements, Trial Arms, and Trial Sets.
The Trial Sets (TS) domain is intended to allow the sponsor to define the planned sets of subjects that result as a combination of the experimental factors of interest on a study (including experimental parameters, treatment strategies, inherent characteristics, and sponsor-defined attributes). By providing a list of these sets in the submission, the sponsor can provide information on which sets have various combinations of experimental factors as defined in the trial protocol. This also allows the sponsor to include information about the groups defined in the protocol.
A trial set is a collection of subjects that have a common set of parameters defined in the protocol, where those parameters include experimental parameters, treatment strategies, inherent characteristics (such as strain)
parameters, and/or sponsor-defined attributes (e.g., control group designation). There should be no planned parameters of interest that could further subdivide a trial set. Each trial set can be assigned to a group. Each trial set can be assigned to an arm, and several trial sets can be assigned to 1 trial arm.
A trial group is a collection of subjects that have been designated with the same sponsor-defined protocol group code. A group consists of 1 or more sets, so this relationship is hierarchical. Note that the relationship between a group and an arm is not hierarchical: A group may contain subjects from several arms, 1 arm, or part of 1 arm. As a result, each group cannot always be assigned to a single arm.
A well-defined trial set has the following characteristics:
A trial set is a planned set of one or more subjects, possessing experimental factors, treatment factors, or sponsor-defined attributes that differentiate the set from other trial sets on the same trial.
Any subject that is selected for the study will be in one and only one trial set (i.e., trial sets are mutually exclusive and do not overlap).
The trial set is associated with a single trial arm (the set of subjects assigned to a treatment strategy). More than 1 trial set may be associated with the same arm; however, any trial set should be associated with only 1 arm. If a trial set appears to be associated with multiple trial arms, then it should be further subdivided into trial sets, each of which is associated with 1 arm through the use of treatment strategy as an experimental factor.
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
DOMAIN | Domain Abbreviation | Char | TX | Identifier | Two-character abbreviation for the domain. | Req |
SETCD | Set Code | Char | Identifier | Short name of the Trial Set. The same element may occur more than once within an Arm. Maximum 8 characters. This represents the Trial Set for which parameters are being submitted. | Req | |
SET | Set Description | Char | Synonym Qualifier | Long description of a specific Trial Set, as defined by the sponsor. | Req | |
TXSEQ | Sequence Number | Num | Identifier | Unique number for this record within this dataset. (This sequence should be unique within the entire dataset because there is no USUBJID.) | Req | |
TXPARMCD | Trial Set Parameter Short Name | Char | Topic | Short character value for the Trial Set parameter described in TXPARM. Maximum 8 characters. | Req | |
TXPARM | Trial Set Parameter | Char | Synonym Qualifier | Term for the Trial Set parameter. Maximum 40 characters. | Req | |
TXVAL | Trial Set Parameter Value | Char | Result Qualifier | Value of the Trial Set parameter (e.g., Fed ad libitum or Restricted Feeding when TXPARM is FEEDREG). Some parameters may be subject to controlled terminology. See the Controlled Terms, Codelist, or Format column in Section 7.4.2 that lists all defined Trial Set parameters. | Req |
Assumptions for Trial Sets (TX) Domain Model
The Trial Sets (TX) domain provides the list of distinct sets of subjects having different experimental factors, treatment factors, inherent characteristics, or distinct sponsor designations as specified in the trial design.
Each trial set must be identified by a SETCD that is unique within the trial. The SETCD is assigned by the sponsor.
Each trial set should have a SPGRPCD in TXPARMCD with corresponding parameter value under TXVAL. In many cases, more than 1 trial set may be assigned the same group number in the protocol. The inclusion of this parameter facilitates the ability to reference information in the protocol provided and as part of the submission.
The SPGRPCD parameter value may be used for sorting when viewing the data. Sponsors should consider utilizing values that will sort alphabetically in an order intended by the sponsor.
Trial sets should be designed so that each individual subject shall participate in 1 and only 1 trial set.
The ARMCD parameter should be used to associate each trial set with a trial arm as defined in the Trial Arms (TA) table. Each trial set should only have 1 ARMCD parameter, but more than 1 trial set may have the same value of the ARMCD parameter.
The TXPARMCD and TXPARM list may be extended by the sponsor as needed to provide the information on experimental factors that differentiate trial sets.
In general, each set should have a distinct combination of TXPARMCD, TXPARM, and TXVAL whenever possible. If 2 trial sets (identified by distinct SETCD values) have the same set of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must contain information that distinguishes the sets from each other.
The sponsor may choose to define subjects of different sexes as distinct trial sets if this is appropriate based upon the trial design. Alternatively, if all other parameters are the same, sets can be defined to contain both sexes under the assumption that it is common practice to analyze male and female subjects separately.
The TXPARMCD values marked as "Yes" in the Should Include column in Section 7.4.2, Trial Set Codes, should be included in a well-formed TX domain submission. These TXPARMCD values are expected to occur in almost all studies and may be necessary for clear interpretation of the data package.
Some --PARMCD values are available to both the Trial Summary (TS) and TX domains in order to allow for further description of how those values apply to individual trial sets. However, if the attributes (TXPARMCD) are identical across trial set, including them in TS is sufficient.
Example for Trial Sets (TX) Domain Model
Example 1: Simple Parallel Design, No Recovery
This example assumes a simple parallel design in which the sponsor-defined protocol specifies the following information. All subjects are to be screened for 7 days prior to randomization into 3 protocol groups:
Group 1 is a control group of 20 subjects, 10 male and 10 female, dosed with vehicle once per day for 28 days.
Group 2 is a low-dose group of 20 subjects, 10 male and 10 female, dosed at 100 mg/kg once per day for 28 days.
Group 3 is a high-dose group of 20 subjects, 10 male and 10 female, dosed at 500 mg/kg once per day for 28 days.
There are no other experimental factors of interest specified in the study design. This example corresponds to Trial Elements Example 1 (see Section 7.2.1.2, Examples for Trial Elements (TE) Domain Model) and the Trial Arms example (see Section 7.3.1.2, Example for Trial Arms (TA) Domain Model). There are only 3 trial sets in this scenario, because there are no nontreatment factors to consider. In this example, the sponsor has chosen to provide a small amount of additional information about each trial set, including the associated arm code, sponsor-defined protocol group number, control group type, group label, and dose level and units, and the sponsor has made the assumption that male and female animals will be compared separately when relevant.
tx.xpt
Row | STUDYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
1 | EXP1 | TX | 1 | Control Group, Vehicle Control once daily | 1 | ARMCD | Arm Code | 1 |
2 | EXP1 | TX | 1 | Control Group, Vehicle Control once daily | 2 | SPGRPCD | Sponsor-Defined Group Code | 1 |
Row | STUDYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
3 | EXP1 | TX | 1 | Control Group, Vehicle Control once daily | 3 | TCNTRL | Control Type | Vehicle Control |
4 | EXP1 | TX | 1 | Control Group, Vehicle Control once daily | 4 | GRPLBL | Group Label | Group 1, Control |
5 | EXP1 | TX | 1 | Control Group, Vehicle Control once daily | 5 | TRTDOS | Dose Level | 0 |
6 | EXP1 | TX | 1 | Control Group, Vehicle Control once daily | 6 | TRTDOSU | Dose Units | mg/kg/day |
7 | EXP1 | TX | 2 | Low-Dose Group, 100 mg/kg Drug a once daily | 7 | ARMCD | Arm Code | 2 |
8 | EXP1 | TX | 2 | Low-Dose Group, 100 mg/kg Drug a once daily | 8 | SPGRPCD | Sponsor-Defined Group Code | 2 |
9 | EXP1 | TX | 2 | Low-Dose Group, 100 mg/kg Drug a once daily | 9 | GRPLBL | Group Label | Group 2, 100 mg/kg/day |
10 | EXP1 | TX | 2 | Low-Dose Group, 100 mg/kg Drug a once daily | 10 | TRTDOS | Dose Level | 100 |
11 | EXP1 | TX | 2 | Low-Dose Group, 100 mg/kg Drug a once daily | 11 | TRTDOSU | Dose Units | mg/kg/day |
12 | EXP1 | TX | 3 | High-Dose Group, 500 mg/kg Drug a once daily | 12 | ARMCD | Arm Code | 3 |
13 | EXP1 | TX | 3 | High-Dose Group, 500 mg/kg Drug a once daily | 13 | SPGRPCD | Sponsor-Defined Group Code | 3 |
14 | EXP1 | TX | 3 | High-Dose Group, 500 mg/kg Drug a once daily | 14 | GRPLBL | Group Label | Group 3, 500 mg/kg/day |
15 | EXP1 | TX | 3 | High-Dose Group, 500 mg/kg Drug a once daily | 15 | TRTDOS | Dose Level | 500 |
16 | EXP1 | TX | 3 | High-Dose Group, 500 mg/kg Drug a once daily | 16 | TRTDOSU | Dose Units | mg/kg/day |
See also Section 7.5, Additional Examples of Trial Elements, Trial Arms, and Trial Sets.
The following is an extensible list of parameters that may be used to describe a Trial Set. The parameters listed as "Yes" in the "Should Include" column provide a relationship between Trial Sets and other information (the trial protocol or the Trial Arms dataset) and should be included in a well-formed TX domain submission. These TXPARMCD values are expected to occur in almost all studies and may be necessary for clear interpretation of the data package.
Should Include | TXPARMCD | TXPARM | Type | Controlled Terms, Codelist, or Format | CDISC Notes |
Yes | ARMCD | Arm Code | Char | The Arm Code of the Trial Arm that is associated with this Trial Set. Each Trial Set should be associated with a single Trial Arm. | |
Yes | SPGRPCD | Sponsor-Defined Group Code | Char | The identifier for the sponsor-defined group (usually a number) to which this Trial Set belongs. In many cases, there will be multiple Trial Sets with the same value of the SPGRPCD variable. This value may be used by the recipient of the submission to reference an external protocol/report document or information submitted in other forms (e.g., summary tables in a PDF submission). | |
Yes | GRPLBL | Group Label | Char | The reporting label for the associated SPGRPCD group. | |
Yes | TRTDOS | Dose Level | Char | Numeric representation of the planned test article dose level. For dose levels that vary over time within a set, a semicolon-delimited string without spaces can be used (e.g., 100;150;7). For more complex dosing regimens, sponsor should enter "SEE PROTOCOL." | |
Yes | TRTDOSU | Dose Units | Char | (UNIT) | Dose level unit for TRTDOS. For more complex dosing regimens, sponsor should enter "SEE PROTOCOL" to match the associated TRTDOS value. |
See CDISC Notes | TCNTRL | Control Type | Char | This parameter should be included if the Trial Set is considered to be a control for this study (or part of a control). This parameter should be used to define the type of control (e.g., Vehicle Control, Positive Control, etc.). | |
BEDCHNG | Bedding Change | Char | Describes the planned frequency of bedding changes for the subjects in this Set (e.g., Every other day, Every 5 days, Every week, etc.). | ||
BEDDING | Bedding | Char | Planned type of bedding material available to the subjects in this Set (e.g., Straw, Corn cob, Shavings, etc.). | ||
DIET | Basal Diet | Char | Describes the planned type of diet to be offered to the subjects in this Set (e.g., Standard diet, Nutrient restricted, etc.). | ||
DOSENDTC | End Date/Time of Dose Interval | Char | ISO 8601 | The planned end date of the dosing interval for this Set, in ISO 8601 format. | |
DOSSTDTC | Start Date/Time of Dose Interval | Char | ISO 8601 | The planned start date of the dosing interval for this Set, in ISO 8601 format. | |
ENVTEMP | Environmental Temperature | Char | The planned environmental temperature for the subjects in this Set. Can be expressed as a single value (80), or a range (75-80). | ||
ENVTEMPU | Environmental Temperature Units | Char | (UNIT) | The units associated with the environmental temperature. Only "C" or "F" is acceptable. | |
FEEDREG | Feeding Regimen | Char | Describes the planned subject feeding regimen for this Set (e.g., Fed ad libitum, Restricted Feeding, Entire Study Fasted, etc.). | ||
HOUSEGRP | Housing Group | Char | The planned grouping of subjects in housing for this Set (e.g., Single-housed, Pair-housed, Triple-housed, Group-housed, etc.). | ||
HOUSETYP | Housing Type | Char | Describes the planned type of housing provided for the subjects in this Set (e.g., Ventilated caging system (IVC), Plastic caging (suspended), Stainless steel caging (suspended), Plastic Micro- barrier caging, Primate Horizontal caging, Primate Vertical caging, Kennel, Pen, Stable, Feline Colony housing, Battery cages, Egg Laying cages, Poultry isolators, Bio-containment Unit, Other, etc.). | ||
HUMIDT | Housing Humidity | Char | The planned housing humidity for the test subjects in this Set. Can be expressed as a single value (75), or as a range (60-70). | ||
HUMIDTU | Housing Humidity Units | Char | (UNIT) | The units associated with the housing humidity. | |
IDMETH | Method of Identification | Char | Describes the planned method of uniquely identifying the subjects for this Set (e.g., Ear tag, Tattoo, Collar, Microchip, etc.). | ||
LIGHT | Light Cycle | Char | Defines the planned light/dark hour cycle for the subjects in this Set. E.g., an entry of "12 / 12" indicates that the subjects will be exposed to 12 hours of light and 12 hours of darkness. Text entry field in the format of nn / nn or nn/nn where n = number. | ||
MTHTRM | Method of Termination | Char | (MTHTRM) | Describes the planned sacrifice procedure for subjects in this Set (e.g., CO2, ANESTHETIZED CERVICAL DISLOCATION, ANESTHETIZED EXSANGUINATION, etc.). | |
PLANFSUB | Planned Number of Female Subjects | Num | Defined as the planned number of Female subjects that will be part of this Set. | ||
PLANMSUB | Planned Number of Male Subjects | Num | Defined as the planned number of Male subjects that will be part of this Set. | ||
SPLANSUB | Planned Number of Subjects | Num | Defined as the planned number of subjects that will be part of this Set. | ||
SETLBL | Set Label | Char | Sponsor-defined label for this Trial Set. This may be used to provide a concise or summary version of the information in the SET variable. | ||
SEXPOP | Sex of Participants | Char | (SEXPOP) | Identifies which sexes of subjects are planned to participate in this Set. | |
SPECIES | Species | Char | (SPECIES) | Used to identify the common species name of the subject (i.e., test system) under study (e.g., MOUSE, RAT, DOG, MONKEY) for this Set. | |
STRAIN | Strain/Substrain | Char | (STRAIN) | Used to identify the vendor-supplied strain, substrain, or breed designation for the test system under study. It may combine the background strain, substrain, and associated genetic modifications as supplied by the vendor (e.g., C57BL/6, A/J, B6.129- |
Pparg<tm2Rev>/J, FISCHER 344, SPRAGUE-DAWLEY IGS, WISTAR Kyoto, BEAGLE, CYNOMOLGUS, and CHIMPANZEE). The SEND Controlled Terminology codelist consists of commonly used wild type and genertically modified strains. It is extensible to accommodate strains not listed and genetically modified substrains for the subjects in this Set. Country or origin for non- human primates should not go into STRAIN. In geneneral, details related to coat color (e.g., White and Red designations for New Zealand Rabbits) should not go into STRAIN. | |||||
SBSTRAIN | Strain/Substrain Details | Char | Free-text field that allows the sponsor to enter additional details regarding the subject (i.e., test system) under study, such as a description of a specific genetic alteration, country of origin for non-human primates, details related to coat color (e.g., White and Red designations for New Zealand Rabbits), and important animal husbandry information (e.g., SPF, BR, VAF). At a subject level, this is recorded in the Demographics (DM) domain. | ||
SPLRLOC | Test Subject Supplier Site | Char | City, state, and country of the subject supplier for subjects in this Set. | ||
SPLRNAM | Test Subject Supplier | Char | The name of the subject supplier for subjects in this Set. | ||
TKDESC | Toxicokinetic Description | Char | This parameter allows the sponsor to provide additional information about whether this Set will (or will not) have samples drawn for toxicokinetic analysis. The text may be simple (TK or NON-TK) or descriptive (Sampled at six time points on Day 1 and end of dosing period). | ||
WATER | Drinking Water | Char | The type of drinking water that is planned to be provided to the subjects in this Set (e.g., Tap water, Acidified, Reverse osmosis, etc.). | ||
WTRDLVRY | Water Delivery | Char | Describes the methods of water delivery systems available for the test subjects in this Set (e.g., Bottled water, Ad lib, Restricted, etc.) |
Additional Examples of Trial Elements, Trial Arms, and Trial Sets
The following examples are intended to show how a variety of study designs would be represented in the Trial Elements, Trial Arms, and Trial Sets domains.
Example 1. Parallel Design with Some Subjects Moving To Recovery
This example assumes a design in which the sponsor-defined protocol specifies the following information. All subjects are to be screened for 7 days prior to randomization into 3 protocol groups:
Group 1 is a control group of 20 subjects, 10 male and 10 female, dosed with vehicle once per day for 28 days. After 28 days, 5 subjects/sex will be terminated and the other half will go on to a 7-day recovery period prior to termination.
Group 2 is a low-dose group of 20 subjects, 10 male and 10 female, dosed at 100 mg/kg once per day for 28 days. After 28 days, 5 subjects/sex will be terminated and the other half will go on to a 7-day recovery period prior to termination.
Group 3 is a high-dose group of 20 subjects, 10 male and 10 female, dosed at 500 mg/kg once per day for 28 days. After 28 days, 5 subjects/sex will be terminated and the other half will go on to a 7-day recovery period prior to termination.
Group Number | Group Label | Dose Level | Number of Animals (Both Sexes Combined) | |
Nonrecovery | Recovery | |||
1 | Group 1, Control | Vehicle Control | 10 | 10 |
2 | Group 2, 100 mg/kg | 100 mg/kg/day | 10 | 10 |
3 | Group 3, 500 mg/kg | 500 mg/kg/day | 10 | 10 |
There are no other experimental factors of interest specified in the study design. In this case, the design consists of 6 trial arms, because there are 6 distinct sequences of elements, as depicted in the following figure.
Trial Elements
This example includes the start and end rule for the recovery element starting after last dose of the drug or vehicle.
te.xpt
Row | STUDYID | DOMAIN | ETCD | ELEMENT | TESTRL | TEENRL | TEDUR |
1 | TDM1 | TE | SCRN | Screen | Start of Pretreatment | 1 week after start of Element | P7D |
2 | TDM1 | TE | TRT01 | Vehicle Control | First day of dosing with vehicle control | 28 days after start of Element | P28D |
3 | TDM1 | TE | TRT02 | 100 mg/kg Drug A, once daily | First day of dosing with 100 mg/kg Drug A | 28 days after start of Element | P28D |
4 | TDM1 | TE | TRT03 | 500 mg/kg Drug A, once daily | First day of dosing with 500 mg/kg Drug A | 28 days after start of Element | P28D |
5 | TDM1 | TE | RECO | Recovery | First day of Recovery | 7 days after start of Element | P7D |
Trial Arms
The 6 trial arms of this study can be depicted as follows:
ta.xpt
Row | STUDYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT | TABRANCH | EPOCH |
1 | TDM1 | TA | 01 | Control | 1 | SCRN | Screen | Randomized to Group 1 | Screen |
2 | TDM1 | TA | 01 | Control | 2 | TRT01 | Vehicle Control | Treatment | |
3 | TDM1 | TA | 01R | Control w/ Recovery | 1 | SCRN | Screen | Randomized to Group 1, planned for recovery | Screen |
4 | TDM1 | TA | 01R | Control w/ Recovery | 2 | TRT01 | Vehicle Control | Treatment | |
5 | TDM1 | TA | 01R | Control w/ Recovery | 3 | RECO | Recovery | Recovery | |
6 | TDM1 | TA | 02 | Low Dose | 1 | SCRN | Screen | Randomized to Group 2 | Screen |
7 | TDM1 | TA | 02 | Low Dose | 2 | TRT02 | 100 mg/kg Drug A | Treatment | |
8 | TDM1 | TA | 02R | Low Dose w/ Recovery | 1 | SCRN | Screen | Randomized to Group 2, planned for recovery | Screen |
9 | TDM1 | TA | 02R | Low Dose w/ Recovery | 2 | TRT02 | 100 mg/kg Drug A | Treatment | |
10 | TDM1 | TA | 02R | Low Dose w/ Recovery | 3 | RECO | Recovery | Recovery | |
11 | TDM1 | TA | 03 | High Dose | 1 | SCRN | Screen | Randomized to Group 3 | Screen |
12 | TDM1 | TA | 03 | High Dose | 2 | TRT03 | 500 mg/kg Drug A | Treatment |
Row | STUDYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT | TABRANCH | EPOCH |
13 | TDM1 | TA | 03R | High Dose w/ Recovery | 1 | SCRN | Screen | Randomized to Group 3, planned for recovery | Screen |
14 | TDM1 | TA | 03R | High Dose w/ Recovery | 2 | TRT03 | 500 mg/kg Drug A | Treatment | |
15 | TDM1 | TA | 03R | High Dose w/ Recovery | 3 | RECO | Recovery | Recovery |
Trial Sets
As noted, there are 6 distinct trial sets. The experimental factors of interest are the dose level to be received during the treatment period and whether the subjects are planned for termination on day 28 or will enter a recovery period.
In this example, the sponsor is providing the arm code, sponsor-defined group code, group label, set label, dose level and units, control type, and planned number of males and females for each set.
tx.xpt
Row | STUDYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
1 | TDM1 | TX | 1NR | Control Group, Vehicle Control once daily, Nonrecovery | 1 | ARMCD | Arm Code | 01 |
2 | TDM1 | TX | 1NR | Control Group, Vehicle Control once daily, Nonrecovery | 2 | SPGRPCD | Sponsor-Defined Group Code | 1 |
3 | TDM1 | TX | 1NR | Control Group, Vehicle Control once daily, Nonrecovery | 3 | GRPLBL | Group Label | Group 1, Control |
4 | TDM1 | TX | 1NR | Control Group, Vehicle Control once daily, Nonrecovery | 4 | SETLBL | Set Label | Group 1, Control - Nonrec |
5 | TDM1 | TX | 1NR | Control Group, Vehicle Control once daily, Nonrecovery | 5 | TRTDOS | Dose Level | 0 |
6 | TDM1 | TX | 1NR | Control Group, Vehicle Control once daily, Nonrecovery | 6 | TRTDOSU | Dose Units | mg/kg/day |
7 | TDM1 | TX | 1NR | Control Group, Vehicle Control once daily, Nonrecovery | 7 | TCNTRL | Control Type | Vehicle Control |
8 | TDM1 | TX | 1NR | Control Group, Vehicle Control once daily, Nonrecovery | 8 | PLANMSUB | Planned Number of Male Subjects | 5 |
9 | TDM1 | TX | 1NR | Control Group, Vehicle Control once daily, Nonrecovery | 9 | PLANFSUB | Planned Number of Female Subjects | 5 |
10 | TDM1 | TX | 1R | Control Group, Vehicle Control once daily, Recovery | 10 | ARMCD | Arm Code | 01R |
11 | TDM1 | TX | 1R | Control Group, Vehicle Control once daily, Recovery | 11 | SPGRPCD | Sponsor-Defined Group Code | 1 |
12 | TDM1 | TX | 1R | Control Group, Vehicle Control once daily, Recovery | 12 | GRPLBL | Group Label | Group 1, Control |
13 | TDM1 | TX | 1R | Control Group, Vehicle Control once daily, Recovery | 13 | SETLBL | Set Label | Group 1, Control - Rec |
14 | TDM1 | TX | 1R | Control Group, Vehicle Control once daily, Recovery | 14 | TRTDOS | Dose Level | 0 |
15 | TDM1 | TX | 1R | Control Group, Vehicle Control once daily, Recovery | 15 | TRTDOSU | Dose Units | mg/kg/day |
16 | TDM1 | TX | 1R | Control Group, Vehicle Control once daily, Recovery | 16 | TCNTRL | Control Type | Vehicle Control |
17 | TDM1 | TX | 1R | Control Group, Vehicle Control once daily, Recovery | 17 | PLANMSUB | Planned Number of Male Subjects | 5 |
18 | TDM1 | TX | 1R | Control Group, Vehicle Control once daily, Recovery | 18 | PLANFSUB | Planned Number of Female Subjects | 5 |
19 | TDM1 | TX | 2NR | Low-Dose Group, 100 mg/kg Drug a once daily, Nonrecovery | 19 | ARMCD | Arm Code | 02 |
20 | TDM1 | TX | 2NR | Low-Dose Group, 100 mg/kg Drug a once daily, Nonrecovery | 20 | SPGRPCD | Sponsor-Defined Group Code | 2 |
21 | TDM1 | TX | 2NR | Low-Dose Group, 100 mg/kg Drug a once daily, Nonrecovery | 21 | GRPLBL | Group Label | Group 2, 100 mg/kg |
22 | TDM1 | TX | 2NR | Low-Dose Group, 100 mg/kg Drug a once daily, Nonrecovery | 22 | SETLBL | Set Label | Group 2, 100 mg/kg - Nonrec |
Row | STUDYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
23 | TDM1 | TX | 2NR | Low-Dose Group, 100 mg/kg Drug a once daily, Nonrecovery | 23 | TRTDOS | Dose Level | 100 |
24 | TDM1 | TX | 2NR | Low-Dose Group, 100 mg/kg Drug a once daily, Nonrecovery | 24 | TRTDOSU | Dose Units | mg/kg/day |
25 | TDM1 | TX | 2NR | Low-Dose Group, 100 mg/kg Drug a once daily, Nonrecovery | 25 | PLANMSUB | Planned Number of Male Subjects | 5 |
26 | TDM1 | TX | 2NR | Low-Dose Group, 100 mg/kg Drug a once daily, Nonrecovery | 26 | PLANFSUB | Planned Number of Female Subjects | 5 |
27 | TDM1 | TX | 2R | Low-Dose Group, 100 mg/kg Drug a once daily, Recovery | 27 | ARMCD | Arm Code | 02R |
28 | TDM1 | TX | 2R | Low-Dose Group, 100 mg/kg Drug a once daily, Recovery | 28 | SPGRPCD | Sponsor-Defined Group Code | 2 |
29 | TDM1 | TX | 2R | Low-Dose Group, 100 mg/kg Drug a once daily, Recovery | 29 | GRPLBL | Group Label | Group 2, 100 mg/kg |
30 | TDM1 | TX | 2R | Low-Dose Group, 100 mg/kg Drug a once daily, Recovery | 30 | SETLBL | Set Label | Group 2, 100 mg/kg - Rec |
31 | TDM1 | TX | 2R | Low-Dose Group, 100 mg/kg Drug a once daily, Recovery | 31 | TRTDOS | Dose Level | 100 |
32 | TDM1 | TX | 2R | Low-Dose Group, 100 mg/kg Drug a once daily, Recovery | 32 | TRTDOSU | Dose Units | mg/kg/day |
33 | TDM1 | TX | 2R | Low-Dose Group, 100 mg/kg Drug a once daily, Recovery | 33 | PLANMSUB | Planned Number of Male Subjects | 5 |
34 | TDM1 | TX | 2R | Low-Dose Group, 100 mg/kg Drug a once daily, Recovery | 34 | PLANFSUB | Planned Number of Female Subjects | 5 |
35 | TDM1 | TX | 3NR | High-Dose Group, 500 mg/kg Drug a once daily, Nonrecovery | 35 | ARMCD | Arm Code | 03 |
36 | TDM1 | TX | 3NR | High-Dose Group, 500 mg/kg Drug a once daily, Nonrecovery | 36 | SPGRPCD | Sponsor-Defined Group Code | 3 |
37 | TDM1 | TX | 3NR | High-Dose Group, 500 mg/kg Drug a once daily, Nonrecovery | 37 | GRPLBL | Group Label | Group 3, 500 mg/kg |
38 | TDM1 | TX | 3NR | High-Dose Group, 500 mg/kg Drug a once daily, Nonrecovery | 38 | SETLBL | Set Label | Group 3, 500 mg/kg - Nonrec |
39 | TDM1 | TX | 3NR | High-Dose Group, 500 mg/kg Drug a once daily, Nonrecovery | 39 | TRTDOS | Dose Level | 500 |
40 | TDM1 | TX | 3NR | High-Dose Group, 500 mg/kg Drug a once daily, Nonrecovery | 40 | TRTDOSU | Dose Units | mg/kg/day |
41 | TDM1 | TX | 3NR | High-Dose Group, 500 mg/kg Drug a once daily, Nonrecovery | 41 | PLANMSUB | Planned Number of Male Subjects | 5 |
42 | TDM1 | TX | 3NR | High-Dose Group, 500 mg/kg Drug a once daily, Nonrecovery | 42 | PLANFSUB | Planned Number of Female Subjects | 5 |
43 | TDM1 | TX | 3R | High-Dose Group, 500 mg/kg Drug a once daily, Recovery | 43 | ARMCD | Arm Code | 03R |
44 | TDM1 | TX | 3R | High-Dose Group, 500 mg/kg Drug a once daily, Recovery | 44 | SPGRPCD | Sponsor-Defined Group Code | 3 |
45 | TDM1 | TX | 3R | High-Dose Group, 500 mg/kg Drug a once daily, Recovery | 45 | GRPLBL | Group Label | Group 3, 500 mg/kg |
46 | TDM1 | TX | 3R | High-Dose Group, 500 mg/kg Drug a once daily, Recovery | 46 | SETLBL | Set Label | Group 3, 500 mg/kg - Rec |
47 | TDM1 | TX | 3R | High-Dose Group, 500 mg/kg Drug a once daily, Recovery | 47 | TRTDOS | Dose Level | 500 |
48 | TDM1 | TX | 3R | High-Dose Group, 500 mg/kg Drug a once daily, Recovery | 48 | TRTDOSU | Dose Units | mg/kg/day |
49 | TDM1 | TX | 3R | High-Dose Group, 500 mg/kg Drug a once daily, Recovery | 49 | PLANMSUB | Planned Number of Male Subjects | 5 |
50 | TDM1 | TX | 3R | High-Dose Group, 500 mg/kg Drug a once daily, Recovery | 50 | PLANFSUB | Planned Number of Female Subjects | 5 |
Example 2. Study With Tk Subjects Within Same Protocol Group and Scheduled Necropsy
This example assumes a design in which the sponsor-defined protocol specifies the following information. All subjects are to be screened for 7 days prior to randomization into 3 protocol groups:
Group 1 is a control group of 20 subjects, 10 male and 10 female, dosed with vehicle once per day for 28 to 30 days. Three subjects of each sex will be subject to blood sampling for the purpose of toxicokinetic (TK) analysis and all remaining animals will be scheduled for necropsy.
Group 2 is a low-dose group of 20 subjects, 10 male and 10 female, dosed at 100 mg/kg once per day for 28 to 30 days. Three subjects of each sex will be subject to blood sampling for the purpose of TK analysis and all remaining animals will be scheduled for necropsy.
Group 3 is a high-dose group of 20 subjects, 10 male and 10 female, dosed at 500 mg/kg once per day for 28 to 30 days. Three subjects of each sex will be subject to blood sampling for the purpose of TK analysis and all remaining animals will be scheduled for necropsy.
Group Number | Group Label | Dose Level | Number of Animals (Both Sexes Combined) | |
Non-Toxicokinetic | Toxicokinetic | |||
1 | Group 1, Control | Vehicle Control | 14 | 6 |
2 | Group 2, 100 mg/kg | 100 mg/kg/day | 14 | 6 |
3 | Group 3, 500 mg/kg | 500 mg/kg/day | 14 | 6 |
There are no other experimental factors of interest specified in the study design. In this case the design consists of 3 trial arms, depicted in the following figure.
Trial Elements
In this study, treatment started on one date and the necropsy is scheduled, for an individual animal, after 28 to 30 days of treatment. The necropsy for a subset of animals per treatment per day will be staggered over a 3-day period.
te.xpt
Row | STUDYID | DOMAIN | ETCD | ELEMENT | TESTRL | TEENRL | TEDUR |
1 | TDM2 | TE | SCRN | Screen | Start of Pretreatment | 1 week after start of Element | P7D |
2 | TDM2 | TE | TRT01 | Vehicle Control | First day of dosing with vehicle control | Date of necropsy: 28 to 30 days after start of Element | |
3 | TDM2 | TE | TRT02 | 100 mg/kg Drug A, once daily | First day of dosing with 100 mg/kg Drug A | Date of necropsy: 28 to 30 days after start of Element | |
4 | TDM2 | TE | TRT03 | 500 mg/kg Drug A, once daily | First day of dosing with 500 mg/kg Drug A | Date of necropsy: 28 to 30 days after start of Element |
Trial Arms
There are three trial arms in this study. The fact that some subjects are being selected for blood sampling is an experimental factor that is separate from the treatment being received; this is described in the TS example.
ta.xpt
Row | STUDYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT | TABRANCH | EPOCH |
1 | TDM2 | TA | 1 | Control | 1 | SCRN | Screen | Randomized to Group 1 | Screen |
2 | TDM2 | TA | 1 | Control | 2 | TRT01 | Vehicle Control | Treatment | |
3 | TDM2 | TA | 2 | 100 mg/kg | 1 | SCRN | Screen | Randomized to Group 2 | Screen |
4 | TDM2 | TA | 2 | 100 mg/kg | 2 | TRT02 | 100 mg/kg Drug A | Treatment | |
5 | TDM2 | TA | 3 | 500 mg/kg | 1 | SCRN | Screen | Randomized to Group 3 | Screen |
6 | TDM2 | TA | 3 | 500 mg/kg | 2 | TRT03 | 500 mg/kg Drug A | Treatment |
Trial Sets
Assuming that the protocol also specifies that subjects with blood sampling for TK analysis are experimentally distinct, the factors of interest are the treatment levels and whether the subject is sampled for TK analysis; this leads to 6 trial sets.
The sponsor has chosen to provide the associated arm code, sponsor-defined group code, group label, set label, dose level and units, control type, whether the trial set is being sampled for TK analysis, and planned number of males and females for each set.
tx.xpt
Row | STUDYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
1 | TDM2 | TX | 1 | Control Group, Vehicle Control once daily, Non-TK | 1 | ARMCD | Arm Code | 1 |
2 | TDM2 | TX | 1 | Control Group, Vehicle Control once daily, Non-TK | 2 | SPGRPCD | Sponsor-Defined Group Code | 1 |
3 | TDM2 | TX | 1 | Control Group, Vehicle Control once daily, Non-TK | 3 | GRPLBL | Group Label | Group 1, Control |
4 | TDM2 | TX | 1 | Control Group, Vehicle Control once daily, Non-TK | 4 | SETLBL | Set Label | Group 1, Control |
5 | TDM2 | TX | 1 | Control Group, Vehicle Control once daily, Non-TK | 5 | TRTDOS | Dose Level | 0 |
6 | TDM2 | TX | 1 | Control Group, Vehicle Control once daily, Non-TK | 6 | TRTDOSU | Dose Units | mg/kg/day |
7 | TDM2 | TX | 1 | Control Group, Vehicle Control once daily, Non-TK | 7 | TCNTRL | Control Type | Vehicle Control |
8 | TDM2 | TX | 1 | Control Group, Vehicle Control once daily, Non-TK | 8 | TKDESC | Toxicokinetic Description | NON-TK |
9 | TDM2 | TX | 1 | Control Group, Vehicle Control once daily, Non-TK | 9 | PLANMSUB | Planned Number of Male Subjects | 7 |
10 | TDM2 | TX | 1 | Control Group, Vehicle Control once daily, Non-TK | 10 | PLANFSUB | Planned Number of Female Subjects | 7 |
11 | TDM2 | TX | 1.TK | Control Group, Vehicle Control once daily, TK | 11 | ARMCD | Arm Code | 1 |
12 | TDM2 | TX | 1.TK | Control Group, Vehicle Control once daily, TK | 12 | SPGRPCD | Sponsor-Defined Group Code | 1 |
13 | TDM2 | TX | 1.TK | Control Group, Vehicle Control once daily, TK | 13 | GRPLBL | Group Label | Group 1, Control |
14 | TDM2 | TX | 1.TK | Control Group, Vehicle Control once daily, TK | 14 | SETLBL | Set Label | Group 1, Control - TK |
15 | TDM2 | TX | 1.TK | Control Group, Vehicle Control once daily, TK | 15 | TRTDOS | Dose Level | 0 |
16 | TDM2 | TX | 1.TK | Control Group, Vehicle Control once daily, TK | 16 | TRTDOSU | Dose Units | mg/kg/day |
17 | TDM2 | TX | 1.TK | Control Group, Vehicle Control once daily, TK | 17 | TCNTRL | Control Type | Vehicle Control |
18 | TDM2 | TX | 1.TK | Control Group, Vehicle Control once daily, TK | 18 | TKDESC | Toxicokinetic Description | TK |
Row | STUDYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
19 | TDM2 | TX | 1.TK | Control Group, Vehicle Control once daily, TK | 19 | PLANMSUB | Planned Number of Male Subjects | 3 |
20 | TDM2 | TX | 1.TK | Control Group, Vehicle Control once daily, TK | 20 | PLANFSUB | Planned Number of Female Subjects | 3 |
21 | TDM2 | TX | 2 | Low-Dose Group, 100 mg/kg Drug a once daily, Non-TK | 21 | ARMCD | Arm Code | 2 |
22 | TDM2 | TX | 2 | Low-Dose Group, 100 mg/kg Drug a once daily, Non-TK | 22 | SPGRPCD | Sponsor-Defined Group Code | 2 |
23 | TDM2 | TX | 2 | Low-Dose Group, 100 mg/kg Drug a once daily, Non-TK | 23 | GRPLBL | Group Label | Group 2, 100 mg/kg/day |
24 | TDM2 | TX | 2 | Low-Dose Group, 100 mg/kg Drug a once daily, Non-TK | 24 | SETLBL | Set Label | Group 2, 100 mg/kg/day |
25 | TDM2 | TX | 2 | Low-Dose Group, 100 mg/kg Drug a once daily, Non-TK | 25 | TRTDOS | Dose Level | 100 |
26 | TDM2 | TX | 2 | Low-Dose Group, 100 mg/kg Drug a once daily, Non-TK | 26 | TRTDOSU | Dose Units | mg/kg/day |
27 | TDM2 | TX | 2 | Low-Dose Group, 100 mg/kg Drug a once daily, Non-TK | 27 | TKDESC | Toxicokinetic Description | NON-TK |
28 | TDM2 | TX | 2 | Low-Dose Group, 100 mg/kg Drug a once daily, Non-TK | 28 | PLANMSUB | Planned Number of Male Subjects | 7 |
29 | TDM2 | TX | 2 | Low-Dose Group, 100 mg/kg Drug a once daily, Non-TK | 29 | PLANFSUB | Planned Number of Female Subjects | 7 |
30 | TDM2 | TX | 2.TK | Low-Dose Group, 100 mg/kg Drug a once daily, TK | 30 | ARMCD | Arm Code | 2 |
31 | TDM2 | TX | 2.TK | Low-Dose Group, 100 mg/kg Drug a once daily, TK | 31 | SPGRPCD | Sponsor-Defined Group Code | 2 |
32 | TDM2 | TX | 2.TK | Low-Dose Group, 100 mg/kg Drug a once daily, TK | 32 | GRPLBL | Group Label | Group 2, 100 mg/kg/day |
33 | TDM2 | TX | 2.TK | Low-Dose Group, 100 mg/kg Drug a once daily, TK | 33 | SETLBL | Set Label | Group 2, 100 mg/kg/day - TK |
34 | TDM2 | TX | 2.TK | Low-Dose Group, 100 mg/kg Drug a once daily, TK | 34 | TRTDOS | Dose Level | 100 |
35 | TDM2 | TX | 2.TK | Low-Dose Group, 100 mg/kg Drug a once daily, TK | 35 | TRTDOSU | Dose Units | mg/kg/day |
36 | TDM2 | TX | 2.TK | Low-Dose Group, 100 mg/kg Drug a once daily, TK | 36 | TKDESC | Toxicokinetic Description | TK |
37 | TDM2 | TX | 2.TK | Low-Dose Group, 100 mg/kg Drug a once daily, TK | 37 | PLANMSUB | Planned Number of Male Subjects | 3 |
38 | TDM2 | TX | 2.TK | Low-Dose Group, 100 mg/kg Drug a once daily, TK | 38 | PLANFSUB | Planned Number of Female Subjects | 3 |
39 | TDM2 | TX | 3 | High-Dose Group, 500 mg/kg Drug a once daily, Non-TK | 39 | ARMCD | Arm Code | 3 |
40 | TDM2 | TX | 3 | High-Dose Group, 500 mg/kg Drug a once daily, Non-TK | 40 | SPGRPCD | Sponsor-Defined Group Code | 3 |
41 | TDM2 | TX | 3 | High-Dose Group, 500 mg/kg Drug a once daily, Non-TK | 41 | GRPLBL | Group Label | Group 3, 500 mg/kg/day |
42 | TDM2 | TX | 3 | High-Dose Group, 500 mg/kg Drug a once daily, Non-TK | 42 | SETLBL | Set Label | Group 3, 500 mg/kg/day |
43 | TDM2 | TX | 3 | High-Dose Group, 500 mg/kg Drug a once daily, Non-TK | 43 | TRTDOS | Dose Level | 500 |
44 | TDM2 | TX | 3 | High-Dose Group, 500 mg/kg Drug a once daily, Non-TK | 44 | TRTDOSU | Dose Units | mg/kg/day |
45 | TDM2 | TX | 3 | High-Dose Group, 500 mg/kg Drug a once daily, Non-TK | 45 | TKDESC | Toxicokinetic Description | NON-TK |
46 | TDM2 | TX | 3 | High-Dose Group, 500 mg/kg Drug a once daily, Non-TK | 46 | PLANMSUB | Planned Number of Male Subjects | 7 |
47 | TDM2 | TX | 3 | High-Dose Group, 500 mg/kg Drug a once daily, Non-TK | 47 | PLANFSUB | Planned Number of Female Subjects | 7 |
48 | TDM2 | TX | 3.TK | High-Dose Group, 500 mg/kg Drug a once daily, TK | 48 | ARMCD | Arm Code | 3 |
49 | TDM2 | TX | 3.TK | High-Dose Group, 500 mg/kg Drug a once daily, TK | 49 | SPGRPCD | Sponsor-Defined Group Code | 3 |
Row | STUDYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
50 | TDM2 | TX | 3.TK | High-Dose Group, 500 mg/kg Drug a once daily, TK | 50 | GRPLBL | Group Label | Group 3, 500 mg/kg/day |
51 | TDM2 | TX | 3.TK | High-Dose Group, 500 mg/kg Drug a once daily, TK | 51 | SETLBL | Set Label | Group 3, 500 mg/kg/day - TK |
52 | TDM2 | TX | 3.TK | High-Dose Group, 500 mg/kg Drug a once daily, TK | 52 | TRTDOS | Dose Level | 500 |
53 | TDM2 | TX | 3.TK | High-Dose Group, 500 mg/kg Drug a once daily, TK | 53 | TRTDOSU | Dose Units | mg/kg/day |
54 | TDM2 | TX | 3.TK | High-Dose Group, 500 mg/kg Drug a once daily, TK | 54 | TKDESC | Toxicokinetic Description | TK |
55 | TDM2 | TX | 3.TK | High-Dose Group, 500 mg/kg Drug a once daily, TK | 55 | PLANMSUB | Planned Number of Male Subjects | 3 |
56 | TDM2 | TX | 3.TK | High-Dose Group, 500 mg/kg Drug a once daily, TK | 56 | PLANFSUB | Planned Number of Female Subjects | 3 |
Example 3. Study With Tk Subjects in Separate Protocol Groups
This example assumes a design in which the sponsor-defined protocol specifies the following information. All subjects are to be screened for 7 days prior to randomization into 6 protocol groups:
Group 1 is a control group of 20 subjects, 10 male and 10 female, dosed with vehicle once per day for 28 days.
Group 2 is a low-dose group of 20 subjects, 10 male and 10 female, dosed at 100 mg/kg with compound A once per day for 14 days and 100 mg/kg with compound B once per day for 14 days.
Group 3 is a high-dose group of 20 subjects, 10 male and 10 female, dosed at 500 mg/kg with compound A once per day for 14 days and 500 mg/kg with compound B once per day for 14 days.
Group 4 is a control group of 6 subjects, 3 male and 3 female, dosed with vehicle once per day for 28 days. This group will be subjected to blood sampling for the purpose of TK analysis, with samples taken on days 14, 21, and 28.
Group 5 is a low-dose group of 6 subjects, 3 male and 3 female, dosed at 100 mg/kg with compound A once per day for 14 days and 100 mg/kg with compound B once per day for 14 days. This group will be subjected to blood sampling for the purpose of TK analysis, with samples taken on days 14, 21, and 28.
Group 6 is a high-dose group of 6 subjects, 3 male and 3 female, dosed at 500 mg/kg with compound A once per day for 14 days and 500 mg/kg with compound B once per day for 14 days. This group will be subjected to blood sampling for the purpose of TK analysis, with samples taken on days 14, 21, and 28.
Group Number | Group Label | Dose Level | Number of Animals (both sexes combined) | |
Non-Toxicokinetic | Toxicokinetic | |||
1 | Group 1, Control | Vehicle Control | 20 | - |
2 | Group 2, 100 mg/kg A, B | 100 mg/kg/day A, B | 20 | - |
3 | Group 3, 500 mg/kg A, B | 500 mg/kg/day A, B | 20 | - |
4 | Group 4, Control | Vehicle Control | - | 6 |
5 | Group 5, 100 mg/kg A, B | 100 mg/kg/day A, B | - | 6 |
6 | Group 6, 500 mg/kg A, B | 500 mg/kg/day A, B | - | 6 |
There are no other experimental factors of interest specified in the study design.
Trial Elements
The TK blood collection has no effect on the structure of the treatment elements.
te.xpt
Row | STUDYID | DOMAIN | ETCD | ELEMENT | TESTRL | TEENRL | TEDUR |
1 | TDM3 | TE | SCRN | Screen | Start of Pretreatment | 1 week after start of Element | P7D |
2 | TDM3 | TE | TRT01 | Vehicle Control | First day of dosing with vehicle control | 28 days after start of Element | P28D |
3 | TDM3 | TE | TRT02A | 100 mg/kg Compound A, once daily | First day of dosing with 100 mg/kg Compound A | 14 days after start of Element | P14D |
4 | TDM3 | TE | TRT02B | 100 mg/kg Compound B, once daily | First day of dosing with 100 mg/kg Compound B | 14 days after start of Element | P14D |
5 | TDM3 | TE | TRT03A | 500 mg/kg Compound A, once daily | First day of dosing with 500 mg/kg Compound A | 14 days after start of Element | P14D |
6 | TDM3 | TE | TRT03B | 500 mg/kg Compound B, once daily | First day of dosing with 500 mg/kg Compound B | 14 days after start of Element | P14D |
Trial Arms
There are 3 trial arms on this study. The fact that some subjects are being selected for blood sampling is an experimental factor that is separate from the treatment being received; see the TS example. The sponsor-defined protocol group numbering is also not addressed in the TA domain. Therefore, the TA dataset for this design is similar to that for Example 1, although the "branching" rule differs, due to the randomization procedure employed. In this case, the sponsor considers all treatment elements for the study to be part of a single treatment epoch.
ta.xpt
Row | STUDYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT | TABRANCH | EPOCH |
1 | TDM3 | TA | 1 | Control | 1 | SCRN | Screen | Randomized to Group 1 or Group 4 | Screen |
2 | TDM3 | TA | 1 | Control | 2 | TRT01 | Vehicle Control | Treatment | |
3 | TDM3 | TA | 2 | 100 mg/kg | 1 | SCRN | Screen | Randomized to Group 2 or Group 5 | Screen |
4 | TDM3 | TA | 2 | 100 mg/kg | 2 | TRT02A | 100 mg/kg Compound A, once daily | Treatment | |
5 | TDM3 | TA | 2 | 100 mg/kg | 3 | TRT02B | 100 mg/kg Compound B, once daily | Treatment | |
6 | TDM3 | TA | 3 | 500 mg/kg | 1 | SCRN | Screen | Randomized to Group 3 or Group 5 | Screen |
7 | TDM3 | TA | 3 | 500 mg/kg | 2 | TRT03A | 500 mg/kg Compound A, once daily | Treatment | |
8 | TDM3 | TA | 3 | 500 mg/kg | 3 | TRT03B | 500 mg/kg Compound B, once daily | Treatment |
Trial Sets
In this case, there are 6 trial sets, corresponding to the following experimental factors: treatment level (3 separate treatment levels) and whether the subjects will be used for TK analysis.
The sponsor has chosen to provide the associated arm code, sponsor-defined group code, group label, set label, dose level and units, control type, toxicokinetic description, and planned number of males and females for each set.
tx.xpt
Row | STUDYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
1 | TDM3 | TX | 1 | Control Group, Vehicle Control, once daily | 1 | ARMCD | Arm Code | 1 |
2 | TDM3 | TX | 1 | Control Group, Vehicle Control, once daily | 2 | SPGRPCD | Sponsor-Defined Group Code | 1 |
3 | TDM3 | TX | 1 | Control Group, Vehicle Control, once daily | 3 | GRPLBL | Group Label | Group 1, Control |
3 | TDM3 | TX | 1 | Control Group, Vehicle Control, once daily | 4 | SETLBL | Set Label | Group 1, Control |
4 | TDM3 | TX | 1 | Control Group, Vehicle Control, once daily | 5 | TRTDOS | Dose Level | 0 |
5 | TDM3 | TX | 1 | Control Group, Vehicle Control, once daily | 6 | TRTDOSU | Dose Units | mg/kg/day |
6 | TDM3 | TX | 1 | Control Group, Vehicle Control, once daily | 7 | TCNTRL | Control Type | Vehicle Control |
7 | TDM3 | TX | 1 | Control Group, Vehicle Control, once daily | 8 | TKDESC | Toxicokinetic Description | NON-TK |
8 | TDM3 | TX | 1 | Control Group, Vehicle Control, once daily | 9 | PLANMSUB | Planned Number of Male Subjects | 10 |
9 | TDM3 | TX | 1 | Control Group, Vehicle Control, once daily | 10 | PLANFSUB | Planned Number of Female Subjects | 10 |
10 | TDM3 | TX | 2 | Low-Dose Group, 100 mg/kg Compound A, 100 mg/kg Compound B, once daily | 11 | ARMCD | Arm Code | 2 |
11 | TDM3 | TX | 2 | Low-Dose Group, 100 mg/kg Compound A, 100 mg/kg Compound B, once daily | 12 | SPGRPCD | Sponsor-Defined Group Code | 2 |
12 | TDM3 | TX | 2 | Low-Dose Group, 100 mg/kg Compound A, 100 mg/kg Compound B, once daily | 13 | GRPLBL | Group Label | Group 2, 100 mg/kg A, B |
13 | TDM3 | TX | 2 | Low-Dose Group, 100 mg/kg Compound A, 100 mg/kg Compound B, once daily | 14 | SETLBL | Set Label | Group 2, 100 mg/kg/day |
14 | TDM3 | TX | 2 | Low-Dose Group, 100 mg/kg Compound A, 100 mg/kg Compound B, once daily | 15 | TRTDOS | Dose Level | 100 |
15 | TDM3 | TX | 2 | Low-Dose Group, 100 mg/kg Compound A, 100 mg/kg Compound B, once daily | 16 | TRTDOSU | Dose Units | mg/kg/day |
16 | TDM3 | TX | 2 | Low-Dose Group, 100 mg/kg Compound A, 100 mg/kg Compound B, once daily | 17 | TKDESC | Toxicokinetic Description | NON-TK |
17 | TDM3 | TX | 2 | Low-Dose Group, 100 mg/kg Compound A, 100 mg/kg Compound B, once daily | 18 | PLANMSUB | Planned Number of Male Subjects | 10 |
18 | TDM3 | TX | 2 | Low-Dose Group, 100 mg/kg Compound A, 100 mg/kg Compound B, once daily | 19 | PLANFSUB | Planned Number of Female Subjects | 10 |
19 | TDM3 | TX | 3 | High-Dose Group, 500 mg/kg Compound A, 500 mg/kg Compound B, once daily | 20 | ARMCD | Arm Code | 3 |
20 | TDM3 | TX | 3 | High-Dose Group, 500 mg/kg Compound A, 500 mg/kg Compound B, once daily | 21 | SPGRPCD | Sponsor-Defined Group Code | 3 |
21 | TDM3 | TX | 3 | High-Dose Group, 500 mg/kg Compound A, 500 mg/kg Compound B, once daily | 22 | GRPLBL | Group Label | Group 3, 500 mg/kg A, B |
Row | STUDYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
22 | TDM3 | TX | 3 | High-Dose Group, 500 mg/kg Compound A, 500 mg/kg Compound B, once daily | 23 | SETLBL | Set Label | Group 3, 500 mg/kg/day |
23 | TDM3 | TX | 3 | High-Dose Group, 500 mg/kg Compound A, 500 mg/kg Compound B, once daily | 24 | TRTDOS | Dose Level | 500 |
24 | TDM3 | TX | 3 | High-Dose Group, 500 mg/kg Compound A, 500 mg/kg Compound B, once daily | 25 | TRTDOSU | Dose Units | mg/kg/day |
25 | TDM3 | TX | 3 | High-Dose Group, 500 mg/kg Compound A, 500 mg/kg Compound B, once daily | 26 | TKDESC | Toxicokinetic Description | NON-TK |
26 | TDM3 | TX | 3 | High-Dose Group, 500 mg/kg Compound A, 500 mg/kg Compound B, once daily | 27 | PLANMSUB | Planned Number of Male Subjects | 10 |
27 | TDM3 | TX | 3 | High-Dose Group, 500 mg/kg Compound A, 500 mg/kg Compound B, once daily | 28 | PLANFSUB | Planned Number of Female Subjects | 10 |
28 | TDM3 | TX | 4 | Control Group, Vehicle Control once daily, TK | 29 | ARMCD | Arm Code | 1 |
29 | TDM3 | TX | 4 | Control Group, Vehicle Control once daily, TK | 30 | SPGRPCD | Sponsor-Defined Group Code | 4 |
30 | TDM3 | TX | 4 | Control Group, Vehicle Control once daily, TK | 31 | GRPLBL | Group Label | Group 4, Control |
31 | TDM3 | TX | 4 | Control Group, Vehicle Control once daily, TK | 32 | SETLBL | Set Label | Group 4, Control - TK |
32 | TDM3 | TX | 4 | Control Group, Vehicle Control once daily, TK | 33 | TRTDOS | Dose Level | 0 |
33 | TDM3 | TX | 4 | Control Group, Vehicle Control once daily, TK | 34 | TRTDOSU | Dose Units | mg/kg/day |
34 | TDM3 | TX | 4 | Control Group, Vehicle Control once daily, TK | 35 | TCNTRL | Control Type | Vehicle Control |
35 | TDM3 | TX | 4 | Control Group, Vehicle Control once daily, TK | 36 | TKDESC | Toxicokinetic Description | TK |
36 | TDM3 | TX | 4 | Control Group, Vehicle Control once daily, TK | 37 | PLANMSUB | Planned Number of Male Subjects | 3 |
37 | TDM3 | TX | 4 | Control Group, Vehicle Control once daily, TK | 38 | PLANFSUB | Planned Number of Female Subjects | 3 |
38 | TDM3 | TX | 5 | Low-Dose Group, 100 mg/kg Compound A, 100 mg/kg Compound B, once daily, TK | 39 | ARMCD | Arm Code | 2 |
39 | TDM3 | TX | 5 | Low-Dose Group, 100 mg/kg Compound A, 100 mg/kg Compound B, once daily, TK | 40 | SPGRPCD | Sponsor-Defined Group Code | 5 |
40 | TDM3 | TX | 5 | Low-Dose Group, 100 mg/kg Compound A, 100 mg/kg Compound B, once daily, TK | 41 | GRPLBL | Group Label | Group 5, 100 mg/kg A, B |
41 | TDM3 | TX | 5 | Low-Dose Group, 100 mg/kg Compound A, 100 mg/kg Compound B, once daily, TK | 42 | SETLBL | Set Label | Group 5, 100 mg/kg/day - TK |
42 | TDM3 | TX | 5 | Low-Dose Group, 100 mg/kg Compound A, 100 mg/kg Compound B, once daily, TK | 43 | TRTDOS | Dose Level | 100 |
43 | TDM3 | TX | 5 | Low-Dose Group, 100 mg/kg Compound A, 100 mg/kg Compound B, once daily, TK | 44 | TRTDOSU | Dose Units | mg/kg/day |
44 | TDM3 | TX | 5 | Low-Dose Group, 100 mg/kg Compound A, 100 mg/kg Compound B, once daily, TK | 45 | TKDESC | Toxicokinetic Description | TK |
45 | TDM3 | TX | 5 | Low-Dose Group, 100 mg/kg Compound A, 100 mg/kg Compound B, once daily, TK | 46 | PLANMSUB | Planned Number of Male Subjects | 3 |
46 | TDM3 | TX | 5 | Low-Dose Group, 100 mg/kg Compound A, 100 mg/kg Compound B, once daily, TK | 47 | PLANFSUB | Planned Number of Female Subjects | 3 |
Row | STUDYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
47 | TDM3 | TX | 6 | High-Dose Group, 500 mg/kg Compound A, 500 mg/kg Compound B, once daily, TK | 48 | ARMCD | Arm Code | 3 |
48 | TDM3 | TX | 6 | High-Dose Group, 500 mg/kg Compound A, 500 mg/kg Compound B, once daily, TK | 49 | SPGRPCD | Sponsor-Defined Group Code | 6 |
49 | TDM3 | TX | 6 | High-Dose Group, 500 mg/kg Compound A, 500 mg/kg Compound B, once daily, TK | 50 | GRPLBL | Group Label | Group 6, 500 mg/kg A, B |
50 | TDM3 | TX | 6 | High-Dose Group, 500 mg/kg Compound A, 500 mg/kg Compound B, once daily, TK | 51 | SETLBL | Set Label | Group 6, 500 mg/kg/day - TK |
51 | TDM3 | TX | 6 | High-Dose Group, 500 mg/kg Compound A, 500 mg/kg Compound B, once daily, TK | 52 | TRTDOS | Dose Level | 500 |
52 | TDM3 | TX | 6 | High-Dose Group, 500 mg/kg Compound A, 500 mg/kg Compound B, once daily, TK | 53 | TRTDOSU | Dose Units | mg/kg/day |
53 | TDM3 | TX | 6 | High-Dose Group, 500 mg/kg Compound A, 500 mg/kg Compound B, once daily, TK | 54 | TKDESC | Toxicokinetic Description | TK |
54 | TDM3 | TX | 6 | High-Dose Group, 500 mg/kg Compound A, 500 mg/kg Compound B, once daily, TK | 55 | PLANMSUB | Planned Number of Male Subjects | 3 |
55 | TDM3 | TX | 6 | High-Dose Group, 500 mg/kg Compound A, 500 mg/kg Compound B, once daily, TK | 56 | PLANFSUB | Planned Number of Female Subjects | 3 |
Example 4. Study With Multiple Experimental Factors
The example depicts a complex multifactorial trial design. The sponsor-defined protocol specifies the following information: All subjects are to be screened for 7 days prior to randomization into 3 protocol groups:
Group 1 is a control group of 40 subjects, 20 male and 20 female, dosed with vehicle once per day for 30 days. Of this group, 10 males and 10 females will be fed ad libitum, while the remainder will be subject to a restricted diet. Half of the subjects will be terminated after 30 days, while the other half will be subject to a 14-day recovery period; the subjects selected for recovery will be divided equally among animals fed ad libitum and those subject to restricted feeding (i.e., 5 males and 5 females with ad libitum feeding will move to recovery, and 5 males and 5 females with restricted diet will also move to recovery).
Group 2 is a low-dose group of 40 subjects, 20 male and 20 female, dosed at 5 mg/kg once per day for 30 days. Of this group, 10 males and 10 females will be fed ad libitum, while the remainder will be subject to a restricted diet. Three subjects of each sex and feeding pattern will be subject to blood sampling for the purpose of TK analysis (i.e., 3 males and 3 females from those fed ad libitum and 3 males and 3 females from those receiving a restricted diet)
Group 3 is a high-dose group of 40 subjects, 20 male and 20 female, dosed at 100 mg/kg once per day for 30 days. Of this group, 10 males and 10 females will be fed ad libitum, while the remainder will be subject to a restricted diet. Of those subjects fed ad libitum, 3 males and 3 females will be subject to blood sampling for the purpose of TK analysis and terminated on day 30; 3 males and 3 females (other than those selected for TK analysis) will be subject to a 14-day recovery period, and the remaining subjects will be terminated on day 30. of the subjects given a restricted diet, 6 males and 6 females will be subject to blood sampling for the purpose of TK analysis; half of these subjects will be terminated on day 30 while the others are subject to a 14-day recovery period before termination. The balance of the subjects receiving a restricted diet will be terminated at the end of the treatment period (day 30).
Group Number | Group Label | Dose Level | Number of Animals (Both Sexes Combined) | |||||||
Fed Ad Libitum | Restricted Feeding | |||||||||
Non-toxicokinetic | Toxicokinetic | Non-toxicokinetic | Toxicokinetic | |||||||
Nonrecovery | Recovery | Nonrecovery | Recovery | Nonrecovery | Recovery | Nonrecovery | Recovery | |||
1 | Group 1, Control | Vehicle Control | 10 | 10 | 0 | 0 | 10 | 10 | 0 | 0 |
2 | Group 2, 5 mg/kg | 5 mg/kg/day | 14 | 0 | 6 | 0 | 14 | 0 | 6 | 0 |
3 | Group 3, 100 mg/kg | 100 mg/kg/day | 8 | 6 | 6 | 0 | 8 | 0 | 6 | 6 |
There are no other experimental factors of interest specified in the study design.
Trial Elements
The variety of feeding and TK analysis factors do not affect the TE dataset, which deals only with treatments. The fact that only some of the treatment elements are combined with the recovery element is only captured in the TA dataset.
te.xpt
Row | STUDYID | DOMAIN | ETCD | ELEMENT | TESTRL | TEENRL | TEDUR |
1 | TDM4 | TE | SCRN | Screen | Start of screening period | 7 days after start of Element | P7D |
2 | TDM4 | TE | CONTROL | Control | 1 day after completion of SCRN Element | 30 days after start of Element | P30D |
3 | TDM4 | TE | T5 | 5 mg/kg Drug A | 1 day after completion of SCRN Element | 30 days after start of Element | P30D |
4 | TDM4 | TE | T100 | 100 mg/kg Drug A | 1 day after completion of SCRN Element | 30 days after start of Element | P30D |
5 | TDM4 | TE | RECO | Recovery | 1 day after last dose with treatment or vehicle control | 14 days after start of Element | P14D |
Despite the complex description in the study protocol, there are only 5 trial arms in this study. All subjects experience a screening element. Based upon the result of randomization, they then receive 1 of 3 different treatments; some of the subjects receiving the vehicle control or the medium dose are subject to a recovery period post-treatment. This can be depicted as follows.
ta.xpt
Row | STUDYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT | TABRANCH | EPOCH |
1 | TDM4 | TA | 1 | Control | 1 | SCRN | Screen | Randomized to Group 1 | Screen |
2 | TDM4 | TA | 1 | Control | 2 | CONTROL | Control | Treatment | |
3 | TDM4 | TA | 1R | Control + Recovery | 1 | SCRN | Screen | Randomized to Group 1 with Recovery | Screen |
4 | TDM4 | TA | 1R | Control + Recovery | 2 | CONTROL | Control | Treatment | |
5 | TDM4 | TA | 1R | Control + Recovery | 3 | RECO | Recovery | Recovery | |
6 | TDM4 | TA | 2 | Low Dose | 1 | SCRN | Screen | Randomized to Group 2 | Screen |
7 | TDM4 | TA | 2 | Low Dose | 2 | T5 | 5 mg/kg Drug A | Treatment | |
8 | TDM4 | TA | 3 | High Dose | 1 | SCRN | Screen | Randomized to Group 3 | Screen |
9 | TDM4 | TA | 3 | High Dose | 2 | T100 | 100 mg/kg Drug A | Treatment | |
10 | TDM4 | TA | 3R | High Dose + Recovery | 1 | SCRN | Screen | Randomized to Group 3 with Recovery | Screen |
11 | TDM4 | TA | 3R | High Dose + Recovery | 2 | T100 | 100 mg/kg Drug A | Treatment | |
12 | TDM4 | TA | 3R | High Dose + Recovery | 3 | RECO | Recovery | Recovery |
Trial Sets
In this study there are multiple experimental factors of interest: the treatment level given during the treatment epoch (3 levels), the feeding regimen of the subjects (ad libitum vs. restricted feeding), whether the subjects are to be used for TK analysis, and whether the subjects will be terminated at the end of the dosing period or experience a recovery period. The combination of these factors (3x2x2x2) could lead to up to 24 possible combinations or sets; however, upon careful reading of the description there are 14 sets that will actually be part of the study:
Vehicle Control + Fed Ad Libitum + No Recovery + No TK analysis
Vehicle Control + Restricted Feeding + No Recovery + No TK analysis
Vehicle Control + Fed Ad Libitum + Recovery + No TK analysis
Vehicle Control + Restricted Feeding + Recovery + No TK analysis
Low Dose + Fed Ad Libitum + No Recovery + No TK analysis
Low Dose + Restricted Feeding + No Recovery + No TK analysis
Low Dose + Fed Ad Libitum + No Recovery + TK analysis
Low Dose + Restricted Feeding + No Recovery + TK analysis
High Dose + Fed Ad Libitum + No Recovery + No TK analysis
High Dose + Fed Ad Libitum + Recovery + No TK analysis
High Dose + Fed Ad Libitum + No Recovery + TK analysis
High Dose + Restricted Feeding + No Recovery + TK analysis
High Dose + Restricted Feeding + Recovery + TK analysis
High Dose + Restricted Feeding + No Recovery + No TK analysis
This can be represented in the TS domain as follows. The sponsor is providing the following information for each set: arm code, sponsor-defined group code, group label, dose level and units, control type, feeding regimen, toxicokinetic description, and planned number of subjects (not broken out by sex).
tx.xpt
Row | STUDYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
1 | TDM4 | TX | 1F1 | Control Group, Control Article Name once daily, Fed Ad Libitum | 1 | ARMCD | Arm Code | 1 |
2 | TDM4 | TX | 1F1 | Control Group, Control Article Name once daily, Fed Ad Libitum | 2 | SPGRPCD | Sponsor-Defined Group Code | 1 |
3 | TDM4 | TX | 1F1 | Control Group, Control Article Name once daily, Fed Ad Libitum | 3 | GRPLBL | Group Label | Group 1, Control |
4 | TDM4 | TX | 1F1 | Control Group, Control Article Name once daily, Fed Ad Libitum | 4 | TRTDOS | Dose Level | 0 |
5 | TDM4 | TX | 1F1 | Control Group, Control Article Name once daily, Fed Ad Libitum | 5 | TRTDOSU | Dose Units | mg/kg/day |
6 | TDM4 | TX | 1F1 | Control Group, Control Article Name once daily, Fed Ad Libitum | 6 | TCNTRL | Control Type | Vehicle Control |
7 | TDM4 | TX | 1F1 | Control Group, Control Article Name once daily, Fed Ad Libitum | 7 | FEEDREG | Feeding Regimen | Ad Libitum |
8 | TDM4 | TX | 1F1 | Control Group, Control Article Name once daily, Fed Ad Libitum | 8 | TKDESC | Toxicokinetic Description | NON-TK |
9 | TDM4 | TX | 1F1 | Control Group, Control Article Name once daily, Fed Ad Libitum | 9 | SPLANSUB | Planned Number of Subjects | 10 |
10 | TDM4 | TX | 1F1R | Control Group, Control Article Name once daily, Fed Ad Libitum, Recovery animals | 10 | ARMCD | Arm Code | 1R |
11 | TDM4 | TX | 1F1R | Control Group, Control Article Name once daily, Fed Ad Libitum, Recovery animals | 11 | SPGRPCD | Sponsor-Defined Group Code | 1 |
12 | TDM4 | TX | 1F1R | Control Group, Control Article Name once daily, Fed Ad Libitum, Recovery animals | 12 | GRPLBL | Group Label | Group 1, Control |
13 | TDM4 | TX | 1F1R | Control Group, Control Article Name once daily, Fed Ad Libitum, Recovery animals | 13 | TRTDOS | Dose Level | 0 |
14 | TDM4 | TX | 1F1R | Control Group, Control Article Name once daily, Fed Ad Libitum, Recovery animals | 14 | TRTDOSU | Dose Units | mg/kg/day |
15 | TDM4 | TX | 1F1R | Control Group, Control Article Name once daily, Fed Ad Libitum, Recovery animals | 15 | TCNTRL | Control Type | Vehicle Control |
16 | TDM4 | TX | 1F1R | Control Group, Control Article Name once daily, Fed Ad Libitum, Recovery animals | 16 | FEEDREG | Feeding Regimen | Ad Libitum |
17 | TDM4 | TX | 1F1R | Control Group, Control Article Name once daily, Fed Ad Libitum, Recovery animals | 17 | TKDESC | Toxicokinetic Description | NON-TK |
18 | TDM4 | TX | 1F1R | Control Group, Control Article Name once daily, Fed Ad Libitum, Recovery animals | 18 | SPLANSUB | Planned Number of Subjects | 10 |
19 | TDM4 | TX | 1F2 | Control Group, Control Article Name once daily, Restricted Diet | 19 | ARMCD | Arm Code | 1 |
20 | TDM4 | TX | 1F2 | Control Group, Control Article Name once daily, Restricted Diet | 20 | SPGRPCD | Sponsor-Defined Group Code | 1 |
21 | TDM4 | TX | 1F2 | Control Group, Control Article Name once daily, Restricted Diet | 21 | GRPLBL | Group Label | Group 1, Control |
22 | TDM4 | TX | 1F2 | Control Group, Control Article Name once daily, Restricted Diet | 22 | TRTDOS | Dose Level | 0 |
23 | TDM4 | TX | 1F2 | Control Group, Control Article Name once daily, Restricted Diet | 23 | TRTDOSU | Dose Units | mg/kg/day |
24 | TDM4 | TX | 1F2 | Control Group, Control Article Name once daily, Restricted Diet | 24 | TCNTRL | Control Type | Vehicle Control |
25 | TDM4 | TX | 1F2 | Control Group, Control Article Name once daily, Restricted Diet | 25 | FEEDREG | Feeding Regimen | Restricted Diet (50g/animal/day) |
26 | TDM4 | TX | 1F2 | Control Group, Control Article Name once daily, Restricted Diet | 26 | TKDESC | Toxicokinetic Description | NON-TK |
Row | STUDYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
27 | TDM4 | TX | 1F2 | Control Group, Control Article Name once daily, Restricted Diet | 27 | SPLANSUB | Planned Number of Subjects | 10 |
28 | TDM4 | TX | 1F2R | Control Group, Control Article Name once daily, Restricted Diet, Recovery animals | 28 | ARMCD | Arm Code | 1R |
29 | TDM4 | TX | 1F2R | Control Group, Control Article Name once daily, Restricted Diet, Recovery animals | 29 | SPGRPCD | Sponsor-Defined Group Code | 1 |
30 | TDM4 | TX | 1F2R | Control Group, Control Article Name once daily, Restricted Diet, Recovery animals | 30 | GRPLBL | Group Label | Group 1, Control |
31 | TDM4 | TX | 1F2R | Control Group, Control Article Name once daily, Restricted Diet, Recovery animals | 31 | TRTDOS | Dose Level | 0 |
32 | TDM4 | TX | 1F2R | Control Group, Control Article Name once daily, Restricted Diet, Recovery animals | 32 | TRTDOSU | Dose Units | mg/kg/day |
33 | TDM4 | TX | 1F2R | Control Group, Control Article Name once daily, Restricted Diet, Recovery animals | 33 | TCNTRL | Control Type | Vehicle Control |
34 | TDM4 | TX | 1F2R | Control Group, Control Article Name once daily, Restricted Diet, Recovery animals | 34 | FEEDREG | Feeding Regimen | Restricted Diet (50g/animal/day) |
35 | TDM4 | TX | 1F2R | Control Group, Control Article Name once daily, Restricted Diet, Recovery animals | 35 | TKDESC | Toxicokinetic Description | NON-TK |
36 | TDM4 | TX | 1F2R | Control Group, Control Article Name once daily, Restricted Diet, Recovery animals | 36 | SPLANSUB | Planned Number of Subjects | 10 |
37 | TDM4 | TX | 2F1 | Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum | 37 | ARMCD | Arm Code | 2 |
38 | TDM4 | TX | 2F1 | Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum | 38 | SPGRPCD | Sponsor-Defined Group Code | 2 |
39 | TDM4 | TX | 2F1 | Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum | 39 | GRPLBL | Group Label | Group 2, 5 mg/kg/day |
40 | TDM4 | TX | 2F1 | Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum | 40 | TRTDOS | Dose Level | 5 |
41 | TDM4 | TX | 2F1 | Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum | 41 | TRTDOSU | Dose Units | mg/kg/day |
42 | TDM4 | TX | 2F1 | Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum | 42 | FEEDREG | Feeding Regimen | Ad Libitum |
43 | TDM4 | TX | 2F1 | Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum | 43 | TKDESC | Toxicokinetic Description | NON-TK |
44 | TDM4 | TX | 2F1 | Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum | 44 | SPLANSUB | Planned Number of Subjects | 14 |
45 | TDM4 | TX | 2F1T | Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum, TK animals | 45 | ARMCD | Arm Code | 2 |
46 | TDM4 | TX | 2F1T | Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum, TK animals | 46 | SPGRPCD | Sponsor-Defined Group Code | 2 |
47 | TDM4 | TX | 2F1T | Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum, TK animals | 47 | GRPLBL | Group Label | Group 2, 5 mg/kg/day |
48 | TDM4 | TX | 2F1T | Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum, TK animals | 48 | TRTDOS | Dose Level | 5 |
49 | TDM4 | TX | 2F1T | Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum, TK animals | 49 | TRTDOSU | Dose Units | mg/kg/day |
50 | TDM4 | TX | 2F1T | Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum, TK animals | 50 | FEEDREG | Feeding Regimen | Ad Libitum |
51 | TDM4 | TX | 2F1T | Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum, TK animals | 51 | TKDESC | Toxicokinetic Description | TK |
Row | STUDYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
52 | TDM4 | TX | 2F1T | Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum, TK animals | 52 | SPLANSUB | Planned Number of Subjects | 6 |
53 | TDM4 | TX | 2F2 | Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet | 53 | ARMCD | Arm Code | 2 |
54 | TDM4 | TX | 2F2 | Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet | 54 | SPGRPCD | Sponsor-Defined Group Code | 2 |
55 | TDM4 | TX | 2F2 | Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet | 55 | GRPLBL | Group Label | Group 2, 5 mg/kg/day |
56 | TDM4 | TX | 2F2 | Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet | 56 | TRTDOS | Dose Level | 5 |
57 | TDM4 | TX | 2F2 | Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet | 57 | TRTDOSU | Dose Units | mg/kg/day |
58 | TDM4 | TX | 2F2 | Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet | 58 | FEEDREG | Feeding Regimen | Restricted Diet (50g/animal/day) |
59 | TDM4 | TX | 2F2 | Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet | 59 | TKDESC | Toxicokinetic Description | NON-TK |
60 | TDM4 | TX | 2F2 | Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet | 60 | SPLANSUB | Planned Number of Subjects | 14 |
61 | TDM4 | TX | 2F2T | Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet, TK animals | 61 | ARMCD | Arm Code | 2 |
62 | TDM4 | TX | 2F2T | Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet, TK animals | 62 | SPGRPCD | Sponsor-Defined Group Code | 2 |
63 | TDM4 | TX | 2F2T | Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet, TK animals | 63 | GRPLBL | Group Label | Group 2, 5 mg/kg/day |
64 | TDM4 | TX | 2F2T | Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet, TK animals | 64 | TRTDOS | Dose Level | 5 |
65 | TDM4 | TX | 2F2T | Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet, TK animals | 65 | TRTDOSU | Dose Units | mg/kg/day |
66 | TDM4 | TX | 2F2T | Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet, TK animals | 66 | FEEDREG | Feeding Regimen | Restricted Diet (50g/animal/day) |
67 | TDM4 | TX | 2F2T | Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet, TK animals | 67 | TKDESC | Toxicokinetic Description | TK |
68 | TDM4 | TX | 2F2T | Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet, TK animals | 68 | SPLANSUB | Planned Number of Subjects | 6 |
69 | TDM4 | TX | 3F1 | High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum | 69 | ARMCD | Arm Code | 3 |
70 | TDM4 | TX | 3F1 | High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum | 70 | SPGRPCD | Sponsor-Defined Group Code | 3 |
71 | TDM4 | TX | 3F1 | High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum | 71 | GRPLBL | Group Label | Group 3, 100 mg/kg/day |
72 | TDM4 | TX | 3F1 | High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum | 72 | TRTDOS | Dose Level | 100 |
73 | TDM4 | TX | 3F1 | High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum | 73 | TRTDOSU | Dose Units | mg/kg/day |
74 | TDM4 | TX | 3F1 | High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum | 74 | FEEDREG | Feeding Regimen | Ad Libitum |
75 | TDM4 | TX | 3F1 | High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum | 75 | TKDESC | Toxicokinetic Description | NON-TK |
76 | TDM4 | TX | 3F1 | High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum | 76 | SPLANSUB | Planned Number of Subjects | 8 |
77 | TDM4 | TX | 3F1R | High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, Recovery animals | 77 | ARMCD | Arm Code | 3R |
78 | TDM4 | TX | 3F1R | High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, Recovery animals | 78 | SPGRPCD | Sponsor-Defined Group Code | 3 |
Row | STUDYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
79 | TDM4 | TX | 3F1R | High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, Recovery animals | 79 | GRPLBL | Group Label | Group 3, 100 mg/kg/day |
80 | TDM4 | TX | 3F1R | High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, Recovery animals | 80 | TRTDOS | Dose Level | 100 |
81 | TDM4 | TX | 3F1R | High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, Recovery animals | 81 | TRTDOSU | Dose Units | mg/kg/day |
82 | TDM4 | TX | 3F1R | High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, Recovery animals | 82 | FEEDREG | Feeding Regimen | Ad Libitum |
83 | TDM4 | TX | 3F1R | High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, Recovery animals | 83 | TKDESC | Toxicokinetic Description | NON-TK |
84 | TDM4 | TX | 3F1R | High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, Recovery animals | 84 | SPLANSUB | Planned Number of Subjects | 6 |
85 | TDM4 | TX | 3F1T | High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, TK animals | 85 | ARMCD | Arm Code | 3 |
86 | TDM4 | TX | 3F1T | High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, TK animals | 86 | SPGRPCD | Sponsor-Defined Group Code | 3 |
87 | TDM4 | TX | 3F1T | High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, TK animals | 87 | GRPLBL | Group Label | Group 3, 100 mg/kg/day |
88 | TDM4 | TX | 3F1T | High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, TK animals | 88 | TRTDOS | Dose Level | 100 |
89 | TDM4 | TX | 3F1T | High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, TK animals | 89 | TRTDOSU | Dose Units | mg/kg/day |
90 | TDM4 | TX | 3F1T | High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, TK animals | 90 | FEEDREG | Feeding Regimen | Ad Libitum |
91 | TDM4 | TX | 3F1T | High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, TK animals | 91 | TKDESC | Toxicokinetic Description | TK |
92 | TDM4 | TX | 3F1T | High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, TK animals | 92 | SPLANSUB | Planned Number of Subjects | 6 |
93 | TDM4 | TX | 3F2 | High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet | 93 | ARMCD | Arm Code | 3 |
94 | TDM4 | TX | 3F2 | High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet | 94 | SPGRPCD | Sponsor-Defined Group Code | 3 |
95 | TDM4 | TX | 3F2 | High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet | 95 | GRPLBL | Group Label | Group 3, 100 mg/kg/day |
96 | TDM4 | TX | 3F2 | High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet | 96 | TRTDOS | Dose Level | 100 |
97 | TDM4 | TX | 3F2 | High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet | 97 | TRTDOSU | Dose Units | mg/kg/day |
98 | TDM4 | TX | 3F2 | High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet | 98 | FEEDREG | Feeding Regimen | Restricted Diet (50g/animal/day) |
99 | TDM4 | TX | 3F2 | High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet | 99 | TKDESC | Toxicokinetic Description | NON-TK |
100 | TDM4 | TX | 3F2 | High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet | 100 | SPLANSUB | Planned Number of Subjects | 8 |
101 | TDM4 | TX | 3F2T | High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK Nonrecovery animals | 101 | ARMCD | Arm Code | 3 |
102 | TDM4 | TX | 3F2T | High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK Nonrecovery animals | 102 | SPGRPCD | Sponsor-Defined Group Code | 3 |
Row | STUDYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
103 | TDM4 | TX | 3F2T | High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK Nonrecovery animals | 103 | GRPLBL | Group Label | Group 3, 100 mg/kg/day |
104 | TDM4 | TX | 3F2T | High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK Nonrecovery animals | 104 | TRTDOS | Dose Level | 100 |
105 | TDM4 | TX | 3F2T | High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK Nonrecovery animals | 105 | TRTDOSU | Dose Units | mg/kg/day |
106 | TDM4 | TX | 3F2T | High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK Nonrecovery animals | 106 | FEEDREG | Feeding Regimen | Restricted Diet (50g/animal/day) |
107 | TDM4 | TX | 3F2T | High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK Nonrecovery animals | 107 | TKDESC | Toxicokinetic Description | TK |
108 | TDM4 | TX | 3F2T | High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK Nonrecovery animals | 108 | SPLANSUB | Planned Number of Subjects | 6 |
109 | TDM4 | TX | 3F2TR | High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK w/Recovery animals | 109 | ARMCD | Arm Code | 3R |
110 | TDM4 | TX | 3F2TR | High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK w/Recovery animals | 110 | SPGRPCD | Sponsor-Defined Group Code | 3 |
111 | TDM4 | TX | 3F2TR | High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK w/Recovery animals | 111 | GRPLBL | Group Label | Group 3, 100 mg/kg/day |
112 | TDM4 | TX | 3F2TR | High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK w/Recovery animals | 112 | TRTDOS | Dose Level | 100 |
113 | TDM4 | TX | 3F2TR | High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK w/Recovery animals | 113 | TRTDOSU | Dose Units | mg/kg/day |
114 | TDM4 | TX | 3F2TR | High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK w/Recovery animals | 114 | FEEDREG | Feeding Regimen | Restricted Diet (50g/animal/day) |
115 | TDM4 | TX | 3F2TR | High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK w/Recovery animals | 115 | TKDESC | Toxicokinetic Description | TK |
116 | TDM4 | TX | 3F2TR | High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK w/Recovery animals | 116 | SPLANSUB | Planned Number of Subjects | 6 |
Example 5. Crossover Design (Latin Square)
This example assumes a crossover design in which the sponsor-defined protocol specifies the following information. All subjects are to be screened for 10 days prior to randomization into 4 protocol groups:
Group 1 is a control group of 20 subjects, 10 male and 10 female, which are to be dosed with vehicle once per day for 14 days, given a 7-day rest period, dosed again with vehicle once per day for 14 days, given a second 7-day rest period, and dosed with vehicle once per day for the final 14 days.
Group 2 is a group of 20 subjects, 10 male and 10 female, which are to be dosed at 50 mg/kg once per day for 14 days, given a 7-day rest period, dosed at 800 mg/kg once per day for 14 days, given a second 7-day rest period, and dosed at 400 mg/kg once per day for the final 14 days.
Group 3 is a group of 20 subjects, 10 male and 10 female, which are to be dosed at 400 mg/kg once per day for 14 days, given a 7-day rest period, dosed at 50 mg/kg once per day for 14 days, given a second 7-day rest period, and dosed at 800 mg/kg once per day for the final 14 days.
Group 4 is a group of 20 subjects, 10 male and 10 female, which are to be dosed at 800 mg/kg once per day for 14 days, given a 7-day rest period, dosed at 400 mg/kg once per day for 14 days, given a second 7-day rest period, and dosed at 50 mg/kg once per day for the final 14 days.
There are no other experimental factors of interest specified in the study design.
Trial Elements
This example shows the start and end rules and durations for the different treatment elements, indicating whether they follow a treatment or nontreatment element.
te.xpt
Row | STUDYID | DOMAIN | ETCD | ELEMENT | TESTRL | TEENRL | TEDUR |
1 | TDM5 | TE | SCRN | Screen | Start of Pretreatment | 10 days after start of Element | P10D |
2 | TDM5 | TE | CONTROL | Vehicle Control | First dosing with vehicle control following a nontreatment Element | 14 days after start of Element | P14D |
3 | TDM5 | TE | REST | Rest for 7 days | 1 day after last dose in a treatment Element | 7 days after start of Element | P7D |
4 | TDM5 | TE | 50A | 50 mg/kg Drug A, once daily | First dosing with 50 mg/kg Drug a following a nontreatment Element | 14 days after start of Element | P14D |
5 | TDM5 | TE | 400A | 400 mg/kg Drug A, once daily | First dosing with 400 mg/kg Drug a following a nontreatment Element | 14 days after start of Element | P14D |
6 | TDM5 | TE | 800A | 800 mg/kg Drug A, once daily | First dosing with 800 mg/kg Drug a following a nontreatment Element | 14 days after start of Element | P14D |
Trial Arms
Based upon the description, there are 4 trial arms.
ta.xpt
Row | STUDYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT | TABRANCH | EPOCH |
1 | TDM5 | TA | 1 | Control | 1 | SCRN | Screen | Randomized to Group 1 | Screen |
2 | TDM5 | TA | 1 | Control | 2 | CONTROL | Vehicle Control | Trt 1 | |
3 | TDM5 | TA | 1 | Control | 3 | REST | Rest for 7 days | Rest 1 | |
4 | TDM5 | TA | 1 | Control | 4 | CONTROL | Vehicle Control | Trt 2 | |
5 | TDM5 | TA | 1 | Control | 5 | REST | Rest for 7 days | Rest 2 | |
6 | TDM5 | TA | 1 | Control | 6 | CONTROL | Vehicle Control | Trt 3 | |
7 | TDM5 | TA | 2 | 50-800-400 | 1 | SCRN | Screen | Randomized to Group 2 | Screen |
8 | TDM5 | TA | 2 | 50-800-400 | 2 | 50A | 50 mg/kg Drug A | Trt 1 | |
9 | TDM5 | TA | 2 | 50-800-400 | 3 | REST | Rest for 7 days | Rest 1 | |
10 | TDM5 | TA | 2 | 50-800-400 | 4 | 800A | 800 mg/kg Drug A | Trt 2 | |
11 | TDM5 | TA | 2 | 50-800-400 | 5 | REST | Rest for 7 days | Rest 2 | |
12 | TDM5 | TA | 2 | 50-800-400 | 6 | 400A | 400 mg/kg Drug A | Trt 3 | |
13 | TDM5 | TA | 3 | 400-50-800 | 1 | SCRN | Screen | Randomized to Group 3 | Screen |
14 | TDM5 | TA | 3 | 400-50-800 | 2 | 400A | 400 mg/kg Drug A | Trt 1 | |
15 | TDM5 | TA | 3 | 400-50-800 | 3 | REST | Rest for 7 days | Rest 1 | |
16 | TDM5 | TA | 3 | 400-50-800 | 4 | 50A | 50 mg/kg Drug A | Trt 2 |
Row | STUDYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT | TABRANCH | EPOCH |
17 | TDM5 | TA | 3 | 400-50-800 | 5 | REST | Rest for 7 days | Rest 2 | |
18 | TDM5 | TA | 3 | 400-50-800 | 6 | 800A | 800 mg/kg Drug A | Trt 3 | |
19 | TDM5 | TA | 4 | 800-400-50 | 1 | SCRN | Screen | Randomized to Group 4 | Screen |
20 | TDM5 | TA | 4 | 800-400-50 | 2 | 800A | 800 mg/kg Drug A | Trt 1 | |
21 | TDM5 | TA | 4 | 800-400-50 | 3 | REST | Rest for 7 days | Rest 1 | |
22 | TDM5 | TA | 4 | 800-400-50 | 4 | 400A | 400 mg/kg Drug A | Trt 2 | |
23 | TDM5 | TA | 4 | 800-400-50 | 5 | REST | Rest for 7 days | Rest 2 | |
24 | TDM5 | TA | 4 | 800-400-50 | 6 | 50A | 50 mg/kg Drug A | Trt 3 |
Trial Sets
In this example, there are 4 trial sets. The experimental factors considered are type of treatment (vehicle control or compound) and sequencing of treatment levels. The sponsor is providing the arm code, sponsor-defined group code, group label, control type, dose level and units, and planned number of subjects (total) only.
tx.xpt
Row | STUDYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
1 | TDM5 | TX | 1 | Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between | 1 | ARMCD | Arm Code | 1 |
2 | TDM5 | TX | 1 | Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between | 2 | SPGRPCD | Sponsor- Defined Group Code | 1 |
3 | TDM5 | TX | 1 | Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between | 3 | GRPLBL | Group Label | Group 1, Control |
4 | TDM5 | TX | 1 | Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between | 4 | TCNTRL | Control Type | Vehicle Control |
5 | TDM5 | TX | 1 | Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between | 5 | TRTDOS | Dose Level | 0 |
6 | TDM5 | TX | 1 | Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between | 6 | TRTDOSU | Dose Units | mg/kg/day |
7 | TDM5 | TX | 1 | Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between | 7 | SPLANSUB | Planned Number of Subjects | 20 |
8 | TDM5 | TX | 2 | Group 2, (Compound Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between | 8 | ARMCD | Arm Code | 2 |
9 | TDM5 | TX | 2 | Group 2, (Compound Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between | 9 | SPGRPCD | Sponsor- Defined Group Code | 2 |
10 | TDM5 | TX | 2 | Group 2, (Compound Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between | 10 | GRPLBL | Group Label | Group 2, 50-800- 400 mg/kg/day |
11 | TDM5 | TX | 2 | Group 2, (Compound Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between | 11 | TRTDOS | Dose Level | SEE PROTOCOL |
12 | TDM5 | TX | 2 | Group 2, (Compound Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between | 12 | TRTDOSU | Dose Units | SEE PROTOCOL |
13 | TDM5 | TX | 2 | Group 2, (Compound Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between | 13 | SPLANSUB | Planned Number of Subjects | 20 |
14 | TDM5 | TX | 3 | Group 3, (Compound Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between | 14 | ARMCD | Arm Code | 3 |
15 | TDM5 | TX | 3 | Group 3, (Compound Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between | 15 | SPGRPCD | Sponsor- Defined Group Code | 3 |
Row | STUDYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
16 | TDM5 | TX | 3 | Group 3, (Compound Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between | 16 | GRPLBL | Group Label | Group 3, 400-50- 800 mg/kg/day |
17 | TDM5 | TX | 3 | Group 3, (Compound Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between | 17 | TRTDOS | Dose Level | SEE PROTOCOL |
18 | TDM5 | TX | 3 | Group 3, (Compound Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between | 18 | TRTDOSU | Dose Units | SEE PROTOCOL |
19 | TDM5 | TX | 3 | Group 3, (Compound Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between | 19 | SPLANSUB | Planned Number of Subjects | 20 |
20 | TDM5 | TX | 4 | Group 4, (Compound Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between | 20 | ARMCD | Arm Code | 4 |
21 | TDM5 | TX | 4 | Group 4, (Compound Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between | 21 | SPGRPCD | Sponsor- Defined Group Code | 4 |
22 | TDM5 | TX | 4 | Group 4, (Compound Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between | 22 | GRPLBL | Group Label | Group 4, 800-400- 50 mg/kg/day |
23 | TDM5 | TX | 4 | Group 4, (Compound Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between | 23 | TRTDOS | Dose Level | SEE PROTOCOL |
24 | TDM5 | TX | 4 | Group 4, (Compound Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between | 24 | TRTDOSU | Dose Units | SEE PROTOCOL |
25 | TDM5 | TX | 4 | Group 4, (Compound Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between | 25 | SPLANSUB | Planned Number of Subjects | 20 |
The Trial Summary (TS) dataset allows the sponsor to submit a summary of the study in a structured format. The TS dataset contains information about the planned study characteristics, identical for all animals which is usually found in the protocol. Each record in the TS dataset contains the value of a parameter, a characteristic of the study, or study level information. For example, TS is used to record basic information about the study such as study title, study type, and GLP status.
Trial Summary – TS
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study within the submission. | Req | |
DOMAIN | Domain Abbreviation | Char | TS | Identifier | Two-character abbreviation for the domain most relevant to the observation. | Req |
TSSEQ | Sequence Number | Num | Identifier | Sequence number used to ensure uniqueness within a TSPARMCD. Allows inclusion of multiple records for the same TSPARMCD, and can be used to join related records. | Req | |
TSGRPID | Group Identifier | Char | Identifier | Used to tie together a group of related records. This is not the sponsor-defined protocol group number. | Exp | |
TSPARMCD | Trial Summary Parameter Short Name | Char | Topic | Short character value for the trial design characteristic described in TSPARM. Value must be 8 characters or less. | Req | |
TSPARM | Trial Summary Parameter | Char | Synonym Qualifier | Term for the trial parameter. Value must be 40 characters or less. | Req | |
TSVAL | Parameter Value | Char | Result Qualifier | Value of the TS parameter (e.g., "FDA" when TSPARM is GLP Type). The values for some parameters may be subject to controlled | Exp |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
terminology. See the Controlled Terms, Codelist, or Format column in Section 7.6.3 that lists all defined parameters. TSVAL can only be null if TSVALNF is populated. | ||||||
TSVALNF | Parameter Null Flavor | Char | (NULLFLAVOR) | Record Qualifier | Null flavor for the value of the TSPARMs, which should be included according to the trial summary code table below if and only if TSVAL is null. | Perm |
Assumptions for Trial Summary (TS) Domain Model
The intent of the Trial Summary (TS) domain is to provide a summary of the study information in dataset format. This is not subject-level data.
For a list of example controlled terms for TSPARM and TSPARMCD, and whether they should be included in a submission, see Section 7.6.2, Trial Summary Codes. TSPARM and TSPARMCD are subject to controlled terminology.
TSVAL may have controlled terminology, depending on the value of TSPARMCD. For the controlled terminology list to be applied to TSVAL for a specific TSPARMCD, see Section 7.6.2, Trial Summary Codes.
TS allows for 1 TSVAL value to span multiple variables (TSVAL-TSVALn), in order to accommodate values longer than 200 characters. This is similar to the conventions used in the Comments (CO) domain to accommodate COVAL values longer than 200 characters. TS and CO are special-purpose domains that allow additional TSVAL/COVAL variables to be added to the dataset, in order to accommodate values longer than 200 characters.
For some types of studies, there will be multiple records in the TS dataset for a single parameter, such as GLP type when a study is conducted in such a way that it complies with several GLP guidances. In this case, when TSPARMCD = GLPTYP there may be 2 (or more) records for TSVAL, one with the value "OECD" and the other with the value "FDA."
Use TSGRPID for linking together multiple parameters (e.g., assign a TSGRPID to show a relationship between multiple species to multiple strains, or assign a TSGRPID to show a relationship between several laboratory sites and locations and individual investigators). Note that any parameters with the same GRPID are related.
The TSSEQ variable is required to identify each record as unique, in cases where the same TSPARMCD is used within the dataset. The TSSEQ variable must be populated for all records within the TS dataset.
The TSPARMCD values marked as "Yes" in the Should Include column in Section 7.6.3, Trial Summary Codes, following the examples should be included in a well-formed TS domain submission. These TSPARMCD values are expected to occur in almost all studies and may be necessary for clear interpretation of the data package. In the event that these values cannot be populated, the TSPARMCD should still be present in the dataset, with an empty (NULL) TSVAL and TSVALNF populated with the appropriate null flavor describing why the value cannot be populated.
Some --PARMCD values are available to both the TS and Trial Sets (TX) domains in order to show the relevant information at the appropriate level. If TSPARMCD values do not differ across trial sets, then these should be described in the TS and need not be in the TX domain.
Examples for Trial Summary (TS) Domain Model
Example 1: Simple Parallel Design with Recovery
In this example, the dataset includes many informational fields that may provide context for the study. TSPARMCD
= "GLPTYP" is included twice in this example, since both GLP types apply for this study. Also, TSGRPID has been used to link records (name, location, country) related to the test facility (TSGRPID = "1") and records related to the test site (TSGRPID = "2"). The study director is associated with the test facility and the principal investigator is associated with the test site. Finally, the primary treatment CAS Registry Number is not known; this is recroded as an empty TSVAL and UNK in the corresponding TSVALNF.
ts.xpt
Row | STUDYID | DOMAIN | TSSEQ | TSGRPID | TSPARMCD | TSPARM | TSVAL | TSVALNF |
1 | XYZ | TS | 1 | SSTYP | Study Type | REPEAT DOSE TOXICITY | ||
2 | XYZ | TS | 1 | SPECIES | Species | RAT | ||
3 | XYZ | TS | 1 | STRAIN | Strain/Substrain | FISCHER 344 | ||
4 | XYZ | TS | 1 | SBSTRAIN | Strain/Substrain Details | NON-DIABETIC OBESE RAT | ||
5 | XYZ | TS | 1 | SPLRNAM | Test Subject Supplier | Example Supplier | ||
6 | XYZ | TS | 1 | SDESIGN | Study Design | PARALLEL | ||
7 | XYZ | TS | 1 | ROUTE | Route of Administration | ORAL | ||
8 | XYZ | TS | 1 | GLPTYP | Good Laboratory Practice Type | FDA | ||
9 | XYZ | TS | 2 | GLPTYP | Good Laboratory Practice Type | OECD | ||
10 | XYZ | TS | 1 | EXPSTDTC | Experimental Start Date | 2008-01-01 | ||
11 | XYZ | TS | 1 | EXPENDTC | Experimental End Date | 2008-02-13 | ||
12 | XYZ | TS | 1 | DOSDUR | Dosing Duration | P28D | ||
13 | XYZ | TS | 1 | STITLE | Study Title | Example of a 4-week Repeat-Dose Toxicity Study in Rats with a 1-week Recovery | ||
14 | XYZ | TS | 1 | SNDIGVER | SEND Implementation Guide Version | SEND Implementation Guide Version 3.0 | ||
15 | XYZ | TS | 1 | SNDCTVER | SEND Controlled Terminology Version | SEND Terminology 2011-01-07 | ||
16 | XYZ | TS | 1 | STCAT | Study Category | TOX | ||
17 | XYZ | TS | 1 | SSPONSOR | Sponsoring Organization | Example Sponsor Inc. | ||
18 | XYZ | TS | 1 | 1 | TSTFNAM | Test Facility Name | Example Contract Lab Name | |
19 | XYZ | TS | 1 | 1 | TSTFLOC | Test Facility Location | 1000 Anywhere Street, Honolulu, HI 11111 | |
20 | XYZ | TS | 1 | 1 | TFCNTRY | Test Facility Country | USA | |
21 | XYZ | TS | 1 | 2 | TSNAM | Test Site Name | Example Subcontract Lab Name | |
22 | XYZ | TS | 1 | 2 | TSLOC | Test Site Location | 1000 Nowhere Street Omaha, NE 88888 | |
23 | XYZ | TS | 1 | 2 | TSCNTRY | Test Site Country | USA | |
24 | XYZ | TS | 1 | STSTDTC | Study Start Date | 2007-12-30 | ||
25 | XYZ | TS | 1 | STENDTC | Study End Date | 2008-06-01 | ||
26 | XYZ | TS | 1 | ASOCSTDY | Associated Study | Associated pharmacokinetic Study | ||
27 | XYZ | TS | 1 | AGETXT | Age Text | 6-8 | ||
28 | XYZ | TS | 1 | AGEU | Age Unit | WEEKS | ||
29 | XYZ | TS | 1 | SPREFID | Sponsor's Reference ID | SP/StudyID | ||
30 | XYZ | TS | 1 | STMON | Sponsor's Monitor | Dr. J. Smith | ||
31 | XYZ | TS | 1 | 1 | STDIR | Study Director | Dr. H. Someone | |
32 | XYZ | TS | 1 | 2 | PINV | Principal Investigator | G. Person | |
33 | XYZ | TS | 1 | IDMETH | Method of Identification | MICROCHIP | ||
34 | XYZ | TS | 1 | IACUC | IACUC Number | 1234A | ||
35 | XYZ | TS | 1 | WATER | Drinking Water | REVERSE OSMOSIS | ||
36 | XYZ | TS | 1 | ENVTEMP | Environmental Temperature | 70-75 | ||
37 | XYZ | TS | 1 | ENVTEMPU | Environmental Temperature Units | F |
Row | STUDYID | DOMAIN | TSSEQ | TSGRPID | TSPARMCD | TSPARM | TSVAL | TSVALNF |
38 | XYZ | TS | 1 | HUMIDT | Housing Humidity | 10-30 | ||
39 | XYZ | TS | 1 | HUMIDTU | Housing Humidity Units | % | ||
40 | XYZ | TS | 1 | LIGHT | Light Cycle | 12/12 | ||
41 | XYZ | TS | 1 | HOUSEGRP | Housing Group | SINGLE | ||
42 | XYZ | TS | 1 | BEDDING | Bedding | STRAW | ||
43 | XYZ | TS | 1 | BEDCHNG | Bedding Change | WEEKLY | ||
44 | XYZ | TS | 1 | MTHTRM | Method of Termination | CO2 | ||
45 | XYZ | TS | 1 | DIET | Basal Diet | STANDARD | ||
46 | XYZ | TS | 1 | FEEDREG | Feeding Regimen | AD LIBITUM | ||
47 | XYZ | TS | 1 | INTSAC | Time to Interim Sacrifice | P14D | ||
48 | XYZ | TS | 1 | TRMSAC | Time to Terminal Sacrifice | P28D | ||
49 | XYZ | TS | 1 | RECSAC | Recovery Period | P35D | ||
50 | XYZ | TS | 1 | TRT | Investigational Therapy or Treatment | Example Compound Name | ||
51 | XYZ | TS | 1 | TRTV | Treatment Vehicle | SALINE | ||
52 | XYZ | TS | 1 | GLPFL | GLP Flag | Y | ||
53 | XYZ | TS | 1 | TRTCAS | Primary Treatment CAS Registry Number | UNK |
Example 2: Crossover Design (Latin Square)
This example reflects a dataset that has been reduced to only those parameters that should always be included.
ts.xpt
Row | STUDYID | DOMAIN | TSSEQ | TSGRPID | TSPARMCD | TSPARM | TSVAL | TSVALNF |
1 | EXP2 | TS | 1 | SSTYP | Study Type | REPEAT DOSE TOXICITY | ||
2 | EXP2 | TS | 1 | SPECIES | Species | RAT | ||
3 | EXP2 | TS | 1 | STRAIN | Strain/Substrain | FISCHER 344 | ||
4 | EXP2 | TS | 1 | SPLRNAM | Test Subject Supplier | HARLAN | ||
5 | EXP2 | TS | 1 | SDESIGN | Study Design | CROSSOVER | ||
6 | EXP2 | TS | 1 | ROUTE | Route of Administration | ORAL | ||
7 | EXP2 | TS | 1 | GLPTYP | Good Laboratory Practice Type | FDA | ||
8 | EXP2 | TS | 1 | EXPSTDTC | Experimental Start Date | 2008-01-01 | ||
9 | EXP2 | TS | 1 | EXPENDTC | Experimental End Date | 2008-03-07 | ||
10 | EXP2 | TS | 1 | TRMSAC | Time to Terminal Sacrifice | P42D | ||
11 | EXP2 | TS | 1 | STSTDTC | Study Start Date | 2007-12-30 | ||
12 | EXP2 | TS | 1 | DOSDUR | Dosing Duration | P42D | ||
13 | EXP2 | TS | 1 | STITLE | Study Title | Example of a Crossover study in the Rat with 3 dose levels and 3 dosing periods | ||
14 | EXP2 | TS | 1 | SNDIGVER | SEND Implementation Guide Version | SEND Implementation Guide Version 3.0 | ||
15 | EXP2 | TS | 1 | SNDCTVER | SEND Controlled Terminology Version | SEND Terminology 2011-01-07 | ||
16 | EXP2 | TS | 1 | STCAT | Study Category | TOX |
Row | STUDYID | DOMAIN | TSSEQ | TSGRPID | TSPARMCD | TSPARM | TSVAL | TSVALNF |
17 | EXP2 | TS | 1 | SSPONSOR | Sponsor Organization | Example Sponsor Inc. | ||
18 | EXP2 | TS | 1 | SPREFID | Sponsor's Reference ID | NOT AVAILABLE | ||
19 | EXP2 | TS | 1 | 1 | TSTFNAM | Test Facility Name | Example Tox Lab Name | |
20 | EXP2 | TS | 1 | 1 | TSTFLOC | Test Facility Location | 10 Somewhere Street, Montgomery, AL 10000 | |
21 | EXP2 | TS | 1 | 1 | TFCNTRY | Test Facility Country | USA | |
22 | EXP2 | TS | 1 | AGETXT | Age Text | 6-8 | ||
23 | EXP2 | TS | 1 | AGEU | Age Unit | WEEKS | ||
24 | EXP2 | TS | 1 | 1 | STDIR | Study Director | Dr. R. Smith | |
25 | EXP2 | TS | 1 | TRT | Investigational Therapy or Treatment | Drug A | ||
26 | EXP2 | TS | 1 | TRTV | Treatment Vehicle | Saline | ||
27 | EXP2 | TS | 1 | GLPFL | GLP Flag | Y | ||
28 | EXP2 | TS | 1 | TRTCAS | Primary Treatment CAS Registry Number | NAV |
The following table provides parameter codes (TSPARMCD) and parameter names (TSPARM) to be included in the Trial Summary (TS) dataset. They represent common types of trial summary information often included for a nonclinical study, at the discretion of the sponsor. The parameters listed as "Yes" in the Should Include column should always be included in the TS dataset, in order to provide proper study definition.
Should Include | TSPARMCD | TSPARM | Type | Controlled Terms, Codelist, or Format | CDISC Notes |
See CDISC Notes | AGE | Age | Num | Age of subjects planned for the study populated as an integer. If the planned age of subjects is a range (e.g., "12-14 days"), then populate the age range in the AGETXT variable. Either the AGE or the AGETXT variable should be populated. Actual age of individual subjects at the start of the study is recorded in the Demographics (DM) domain AGE or AGETXT variable as appropriate. | |
See CDISC Notes | AGETXT | Age Text | Char | The age of the subjects at study start, as planned, expressed as a range. If an age integer value is available, then populate the AGE variable instead. Either the AGE or AGETXT variable should be populated. Actual age of individual subjects at the start of the study is recorded in the Demographics (DM) domain AGE or AGETXT variable as appropriate. | |
Yes | AGEU | Age Unit | Char | (AGEU) | Units associated with AGE and AGETXT (e.g., WEEKS, MONTHS, etc.). Individual AGEU of a USUBJID is recorded in the Demographics (DM) domain. A single AGEU for the study should be presented in the Trial Summary dataset. There is no requirement for AGEU in TS to be the same value as AGEU in DM.. |
Yes | SDESIGN | Study Design | Char | (DESIGN) | Describes the overall study plan/type, i.e., what will be done to the subjects, in order to answer certain questions about the Test Article to be administered, and how the Test Article is going to be administered (e.g., Cross-over, Latin Square, etc.). The most appropriate single value, as defined by the sponsor, should be included for Trial Summary purposes. |
Yes | DOSDUR | Dosing Duration | Char | ISO 8601 | The longest planned duration from the start of dosing to the first day of planned terminal disposition of the subjects (not including recovery) in ISO 8601 format. |
Yes | EXPENDTC | Experimental End Date | Char | ISO 8601 | Experimental completion date means the last date on which data are collected from the study (OECD). This date is sponsor defined, and is usually documented in the protocol. |
Should Include | TSPARMCD | TSPARM | Type | Controlled Terms, Codelist, or Format | CDISC Notes |
Yes | EXPSTDTC | Experimental Start Date | Char | ISO 8601 | Experimental starting date means the date on which the first study specific data are collected (OECD). This is sponsor defined, and is usually documented in the protocol. |
Yes | GLPFL | GLP Flag | Char | (NY) | Indicates in the protocol whether a study was conducted according to Good Laboratory Practices (GLP). |
Yes | ROUTE | Route of Administration | Char | (ROUTE) | The delivery method by which the Test Article is administered to the subjects. Subject-level dosing is recorded in the Exposure (EX) domain. TSGRPID may be used to relate ROUTE records to specific TRT records as needed. |
Yes | SNDIGVER | SEND Implementation Guide Version | Char | (SNDIGVER) | The SEND Implementation Guide version used for the submission containing this dataset. Only a single record should be provided in the Trial Summary dataset. |
Yes | SNDCTVER | SEND Controlled Terminology Version | Char | The SEND Controlled Terminology version used for the study dataset for this submission. An example of the appropriate format for TSVAL associated with this PARM/PARMCD combination is "SEND Terminology 2011-01-07" where "SEND Terminology" is the base name of the controlled terminology file, and "2011-01-07" is the publication date of the file in ISO 8601 format. The publication date can be found in the "SourceSystemVersion" attribute of the ODM tag in the ODM XML version of the controlled terminology file. Only a single record should be provided in the Trial Summary. | |
Yes | SPECIES | Species | Char | (SPECIES) | Used to identify the common species name of the subject (i.e., test system) under study (e.g., MOUSE, RAT, DOG, MONKEY). Individual species of a USUBJID is recorded in the Demographics (DM) domain. |
Yes | SPLRNAM | Test Subject Supplier | Char | The name of the subject supplier. If there are multiple suppliers, individual SPLRNAM for a USUBJID may be recorded in the Subject Characteristics (SC) domain. TSGRPID may be used to relate SPLRNAM to specific SPLRLOC records. | |
Yes | SPREFID | Sponsor's Reference ID | Char | The reference identifier by which the study is known to the sponsor. This may be different from the STUDYID if the data were collected under a different identifier in the GLP protocol. For example, this would be used in a situation where a contract facility performs the study and provides a final report. | |
Yes | SSPONSOR | Sponsoring Organization | Char | The name of the company (or person) who initiates, supports, or submits the nonclinical study. The parameter contains the name of the specific sponsor or applicant. | |
Yes | STCAT | Study Category | Char | (STCAT) | Describes the general category of scientific study. The most appropriate single value, as defined by the sponsor, should be included for Trial Summary purposes. |
Yes | STDIR | Study Director | Char | The Study Director is the individual responsible for the overall conduct of the nonclinical study. The parameter contains the name of the specific individual, e.g. "Dr. William Spock." | |
Yes | STRAIN | Strain/Substrain | Char | (STRAIN) | Used to identify the vendor-supplied strain/substrain designation for the subject (i.e., test system) under study. When applicable, it combines the root strain, substrain, and associated genetic modifications, as supplied by the vendor (e.g., C57BL/6, A/J, B6.129-Pparg<tm2Rev>/J, FISCHER 344, SPRAGUE DAWLEY IGS, WISTAR Kyoto, BEAGLE, CYNOMOLGUS, CHIMPANZEE). The SEND Controlled Terminology codelist consists of commonly used wild-type and genetically modified strains. The codelist is extensible to accommodate strains not listed, as well as genetically modified substrains. Individual STRAIN of a USUBJID is recorded in the Demographics (DM) domain. |
Yes | STSTDTC | Study Start Date | Char | ISO 8601 | The Study Start Date, the date on which the study protocol or plan is approved (signed) by the Study Director. Also known as the study initiation date. |
Should Include | TSPARMCD | TSPARM | Type | Controlled Terms, Codelist, or Format | CDISC Notes |
Yes | STITLE | Study Title | Char | The title of the nonclinical study. | |
Yes | SSTYP | Study Type | Char | (SSTYP) | Generalized categorization of the kind of nonclinical study to be conducted (e.g., ABSORPTION, BIOAVAILABILITY, CARDIOVASCULAR PHARMACOLOGY, REPEAT DOSE TOXICITY, CNS PHARMACOLOGY, etc.). The most appropriate single value, as defined by the sponsor, should be included for Trial Summary purposes. |
Yes | TRT | Investigational Therapy or Treatment | Char | The name of the planned Test Article, treatment, therapy administered during the study. Multiple entries may be included as multiple rows where applicable subject-level dosing is recorded in the Exposure (EX) domain. | |
Yes | TFCNTRY | Test Facility Country | Char | (COUNTRY) | The country where the Test Facility is located. |
Yes | TSTFLOC | Test Facility Location | Char | The full postal address of the Test Facility. | |
Yes | TSTFNAM | Test Facility Name | Char | The name of the Test Facility responsible for the overall conduct of the nonclinical study, or the facility administering the Test Article to Test Subjects. TSGRPID may be used to relate this to specific TSVAL values when TSPARMCD = "TFCNTRY," "TSTFLOC," and "STDIR." | |
Yes | TRMSAC | Time to Terminal Sacrifice | Char | ISO 8601 | The duration from the start of dosing to the first day of planned terminal disposition of the subjects in ISO 8601 format. Typically this will be the disposition at the end of the dosing period. TSVAL values associated with this TSPARMCD would be "P28D" for a duration of 28 days; "P4W" would be equally appropriate, if that is defined in the protocol. Multiple records should be used if more than one terminal sacrifice period is defined in the protocol. |
Yes | TRTCAS | Primary Treatment CAS Registry Number | Char | Test Article Chemical Abstracts Service (CAS) Registry Number. | |
Yes | TRTUNII | Primary Treatment Unique Ingredient ID | Char | Test Article Unique Ingredient Identifier. For information related to the UNII, follow this link. http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem- UniqueIngredientIdentifierUNII/default.htm | |
Yes | TRTV | Treatment Vehicle | Char | Vehicle for administration of treatment, such as a liquid in which the treatment drug is dissolved (e.g., Saline). Individual TRTV for a USUBJID is recorded in the Exposure (EX) domain. | |
ALTSTDID | Alternate Study ID | Char | Describes any other identities used for the nonclinical study, e.g. if the study is identified by multiple numbers for operational reasons. | ||
ASOCSTDY | Associated Study | Char | Identifies any other study or studies conducted in support of the primary study. The parameter would list the STUDYID of the associated studies. Examples of this would be STUDYID1, STUDYID2, etc. | ||
BEDCHNG | Bedding Change | Char | Describes the planned frequency of bedding changes for the subjects. TSVAL values associated with this TSPARMCD would be Every other day, Every 5 days, Every week, etc. | ||
BEDDING | Bedding | Char | Planned type of bedding material available to the subjects. TSVAL values associated with this TSPARMCD would be Straw, Corn cob, Shavings, etc. | ||
DIET | Basal Diet | Char | Describes the planned type of diet offered to the subject. TSVAL values associated with this TSPARMCD would be Standard Diet, Nutrient Restricted, etc. Individual DIET for a USUBJID may be recorded in the Subject Characteristics (SC) domain, if the diet is not varied during the course |
Should Include | TSPARMCD | TSPARM | Type | Controlled Terms, Codelist, or Format | CDISC Notes |
of the study. Amount of food and water consumed at the USUBJID level would be recorded in the FW domain. | |||||
DOSENDTC | End Date/Time of Dose Interval | Char | ISO 8601 | The end date of the dosing interval on the study, as defined by the protocol, in ISO 8601 format. | |
DOSSTDTC | Start Date/Time of Dose Interval | Char | ISO 8601 | The start date of the dosing interval on the study, as defined by the protocol, in ISO 8601 format. | |
ENVTEMP | Environmental Temperature | Char | The planned environmental temperature for the test subjects. Can be expressed as either a single value (80), or a range (75-80). | ||
ENVTEMPU | Environmental Temperature Units | Char | (UNIT) | The units associated with the environmental temperature. Only "C" or "F" is acceptable. | |
FEEDREG | Feeding Regimen | Char | Describes the subject-feeding regimen. TSVAL values associated with this TSPARMCD would be Fed ad libitum, Restricted Feeding, Entire Study Fasted, etc. Individual FEEDREG for a USUBJID may be recorded in the Subject Characteristics (SC) domain, if the feeding regimen is not varied during the course of the study. | ||
GLPTYP | Good Laboratory Practice Type | Char | The type of regulation to which the study will adhere. These regulations are generally described in the study protocol. Multiple records (with different TSSEQ values) may be used to describe multiple regulation types. This parameter may also be used to indicate if the study is exploratory and does not fall under a particular regulation (e.g., OECD, FDA, JMHW, EMEA, MHRA, NONE, etc.). | ||
HOUSEGRP | Housing Group | Char | The planned grouping of subjects housed in the same arrangement. TSVAL values associated with this TSPARMCD would be Single-housed, Pair-housed, Group-housed, etc. | ||
HOUSETYP | Housing Type | Char | Describes the planned type of housing provided for the subjects. TSVAL values associated with this TSPARMCD would be Ventilated caging system (IVC), Plastic caging (suspended), Stainless steel caging (suspended), Plastic Micro-barrier caging, Primate Horizontal caging, Primate Vertical caging, Kennel, Pen, Stable, Feline Colony housing, Battery cages, Egg Laying cages, Poultry isolators, Biocontainment Unit, etc. | ||
HUMIDT | Housing Humidity | Char | The planned housing humidity for the subjects. Can be expressed as a single value (75) or as a range (60–70). | ||
HUMIDTU | Housing Humidity Units | Char | (UNIT) | The units associated with the housing humidity. | |
IACUC | IACUC Number | Char | Institutional Animal Care and Use Committee number. | ||
IDMETH | Method of Identification | Char | Describes the method of uniquely identifying the Test Subject. TSVAL values associated with this TSPARMCD would be Ear tag, Tattoo, Collar, Microchip, etc. | ||
INTERIM | Interim Study Flag | Char | (NY) | Indicates that the datasets for this study are interim datasets. | |
INTSAC | Time to Interim Sacrifice | Char | ISO 8601 | The duration from the start of dosing to the first day of planned interim disposition of the subjects in ISO 8601 format. TSVAL values associated with this TSPARMCD would be "P14D" for a duration of 14 days. Multiple records should be used if more than one interim sacrifice period is defined in the protocol. | |
SLENGTH | Study Length | Char | ISO 8601 | The planned length of time for a subject's participation in ISO 8601 format. TSVAL values associated with this TSPARMCD would be "P5M" for a duration of 5 months or "P2W" for a duration of 2 weeks. |
Should Include | TSPARMCD | TSPARM | Type | Controlled Terms, Codelist, or Format | CDISC Notes |
LIGHT | Light Cycle | Char | Defines the planned light/dark hour cycle for the subjects (e.g., TSVAL values associated with this TSPARMCD would be "12 / 12" indicating that the subjects will be exposed to 12 hours of light and 12 hours of darkness). Text entry field in the format of nn / nn or nn/nn where n = number. | ||
MTHTRM | Method of Termination | Char | (MTHTRM) | Describes the planned sacrifice procedure. | |
PINV | Principal Investigator | Char | Name of the Principal Investigator. The TSVAL value contains the name of the specific individual, e.g., "Dr. William Spock." | ||
SPLANSUB | Planned Number of Subjects | Num | The planned total number of subjects that will participate in the study. | ||
PCLASS | Class of Compound | Char | Class for a treatment compound. TSVAL values associated with this TSPARMCD would be COX2, ACE inhibitor, etc. | ||
PPL | Project License Number | Char | Project License Number (specific to UK only). | ||
SRANDOM | Study is Randomized | Char | (NY) | Identifies whether the study is randomized. TSVAL values associated with this TSPARMCD would be "Y" or "N." | |
RECSAC | Recovery Period | Char | ISO 8601 | The duration from the end of dosing to the first day of planned disposition of the recovery subjects in ISO 8601 format. TSVAL values associated with this TSPARMCD would be "P35D" for a duration of 35 days. Multiple records should be used if more than one recovery sacrifice period is defined in the protocol. | |
SEXPOP | Sex of Participants | Char | (SEXPOP) | Planned sex of subjects to participate in the study. | |
SPLRLOC | Test Subject Supplier Site | Char | City, state and country of the subject supplier if only one site. If there are multiple supplier sites, individual SPLRLOC for a USUBJID may be recorded in the Subject Characteristics (SC) domain. | ||
STENDTC | Study End Date | Char | ISO 8601 | The Study End Date: the date on which the final report is approved (signed) by Study Director. Also known as the study completion date. | |
STMON | Sponsor's Monitor | Char | The individual responsible for the periodic follow-up regarding the conduct of the nonclinical study. TSVAL values associated with this TSPARMCD would be the specific name of an individual, e.g., "Dr. William Spock." | ||
SBSTRAIN | Strain/Substrain Details | Char | Free-text field that allows the sponsor to enter further details qualifiying the SPECIES and/or STRAIN, depending on the level to which these variables were defined. Examples include the description of a specific genetic alteration, country of origin for non-human primates, details related to coat color (e.g., White and Red designations for New Zealand Rabbits), and important animal husbandry information (e.g., SPF, BR, VAF). | ||
TSCNTRY | Test Site Country | Char | (COUNTRY) | The country where the Test Site is located (e.g., if the TK analysis is performed at a site other than the Test Facility, then this parameter's TSVAL would be the country of the site at which the TK analysis is performed). | |
TSLOC | Test Site Location | Char | The full postal address of the site where the relevant part of the study is actually conducted (e.g., if the TK analysis is performed at a site other than the Test Facility, then this parameter's TSVAL would be the address of the site at which the TK analysis is performed). | ||
TSNAM | Test Site Name | Char | The name of the site where part(s) of the study is actually conducted. Can be used when part(s) of the nonclinical study is conducted at a different site than the Test Facility site (e.g., when a company has multiple site locations within the same country). This parameter could also be used |
Should Include | TSPARMCD | TSPARM | Type | Controlled Terms, Codelist, or Format | CDISC Notes |
to designate when a study was conducted at a contract site. TSGRPID may be used to relate this to specific TSLOC, TSCNTRY, and PINV records. | |||||
WATER | Drinking Water | Char | The planned type of drinking water that is to be provided to the test subject. TSVAL values associated with this TSPARMCD would be Tap water, Acidified, Reverse osmosis, etc. Amount of food and water consumed at the USUBJID level would be recorded in the FW domain. | ||
WTRDLVRY | Water Delivery | Char | Describes the planned methods of water delivery available for the test subject. TSVAL values associated with this TSPARMCD would be Bottled water, Ad lib, Restricted, etc. |
The variable TSVALNF is based on the idea of a "null flavor" as embodied in ISO 21090.[1] A null flavor is an ancillary piece of data that provides additional information when its primary piece of data is null (has a missing value). There is controlled terminology for the null flavor data item, which includes such familiar values as "Unknown", "Other", and "Not Applicable" among its 15 terms.
The proposal to include a null flavor variable to supplement the TSVAL variable in the Trial Summary (TS) dataset arose when the TS subteam realized that they did not have a good way to represent a protocol that placed no upper limit on the age of study subjects. When the trial summary parameter is AGEMAX, then TSVAL should have a value expressed as an ISO8601 time duration (e.g., P43Y for 43 years old, P6M for 6 months old). The team considered allowing a value such as "NONE" or "UNBOUNDED" to be entered in TSVAL, but realized that if this were allowed, then validation programs would have to recognize this special term as an exception to the expected data format. The team eventually chose to propose a separate null flavor variable that uses the ISO 21090 null flavor terminology.
The controlled terminology for null flavor is included below.
NullFlavor Enumeration. OID: 2.16.840.1.113883.5.1008 | |||
1 | NI | No information | The value is exceptional (missing, omitted, incomplete, improper). No information as to the reason for being an exceptional value is provided. This is the most general exceptional value. It is also the default exceptional value. |
2 | INV | Invalid | The value as represented in the instance is not a member of the set of permitted data values in the constrained value domain of a variable. |
3 | OTH | Other | The actual value is not a member of the set of permitted data values in the constrained value domain of a variable (e.g. concept not provided by required code system). |
4 | PINF | Positive infinity | Positive infinity of numbers. |
4 | NINF | Negative infinity | Negative infinity of numbers. |
3 | UNC | Unencoded | No attempt has been made to encode the information correctly but the raw source information is represented (usually in originalText). |
3 | DER | Derived | An actual value may exist, but it must be derived from the information provided (usually an expression is provided directly). |
2 | UNK | Unknown | A proper value is applicable, but not known. |
3 | ASKU | Asked but unknown | Information was sought but not found (e.g. patient was asked but didn't know). |
4 | NAV | Temporarily unavailable | Information is not available at this time, but it is expected that it will be available later. |
3 | NASK | Not asked | This information has not been sought (e.g. patient was not asked). |
3 | QS | Sufficient quantity | The specific quantity is not known, but is known to be non-zero and is not specified because it makes up the bulk of the material. 'Add 10 mg of ingredient X, 50 mg of ingredient Y, and sufficient quantity of water to 100 ml.' the null flavor would be used to express the quantity of water |
3 | TRC | Trace | The content is greater than zero, but too small to be quantified. |
2 | MSK | Masked | There is information on this item available, but it has not been provided by the sender due to security, privacy or other reasons. There may be an alternate mechanism for gaining access to this information. WARNING — Use of this null flavor does provide information that may be a breach of confidentiality, even though no detailed data are provided. Its primary purpose is for those circumstances where it is necessary to inform the receiver that the information does exist without providing any detail. |
2 | NA | Not applicable | No proper value is applicable in this context (e.g. last menstrual period for a male). |
The numbers in the first column of the table describe the hierarchy of these values:
No information
Invalid
Other
Positive infinity
Negative infinity
Unencoded
Derived
Unknown
Asked but unknown
Temporarily unavailable
Not asked
Quantity sufficient
Trace
Masked
Not applicable
The "No information" is the least informative. It merely confirms that the primary piece of data is null.
The values at level 2 provide a little more information, distinguishing between situations where the primary piece of data is not applicable and those where it is applicable but masked, unknown, or "invalid" (i.e., not in the correct format to be represented in the primary piece of data).
The values at levels 3 and 4 provide successively more information about the situation. For example, for the MAXAGE case that provided the impetus for the creation of the TSVALNF variable, the value PINF means that there is information about the maximum age but it is not something that can be expressed, as in the ISO8601 quantity of time format required for populating TSVAL. The null flavor PINF provides the most complete information possible in this case (i.e., that the maximum age for the study is unbounded).
1. International Organization for Standardization. ISO 21090:2011. Health informatics — Harmonized data types for information interchange. ISO; 2011. Accessed March 26, 2020. https://www.iso.org/standard/35646.html
CDISC Standard for Exchange of Nonclinical Data Implementation Guide: Nonclinical Studies (Version 3.1.1 Final)
Representing Relationships and Data
The fixed structures of the SDTM general observation classes may restrict the ability of sponsors to represent all the data they wish to submit. Collected data that may not entirely fit includes relationships between records within a domain, records in separate domains, and sponsor-defined "variables." As a result, the SDTM has methods to represent distinct types of relationships, all of which are described in more detail in subsequent sections.
Section 8.1, Relating Groups of Records Within a Domain Using the --GRPID Variable, describes representing a relationship between a group of records for a given subject within the same domain.
Section 8.2, Relating Records - RELREC, describes relationships between records in separate domains, either at a record-to-record level or at a domain-to-domain level.
Section 8.3, Supplemental Qualifiers - SUPP-- Datasets, describes a method for representing the dependent relationship where data that cannot be represented by a standard variable within a general observation class domain record (or records) can be related back to that record.
Section 8.4, Relating Comments To a Parent Domain, describes a dependent relationship between a comment in the Comments domain (see Section 5.2, Comments) and a parent record (or records) in other datasets (e.g., a comment recorded in association with an adverse event).
Section 8.5, Relating Findings To Multiple Subjects - Subject Pooling, describes a method for relating one finding for multiple subjects.
Section 8.6, How To Determine Where Data Belong in SEND, discusses the concept of related datasets and whether to place additional data in a separate domain or a supplemental qualifier special-purpose dataset, and the concept of modeling findings data that refer to data in another general observation class dataset.
All relationships make use of the standard domain identifiers, STUDYID, DOMAIN, and sometimes USUBJID or POOLID. In addition, the variables IDVAR and IDVARVAL are used for identifying the record-level merge/join keys. These 5 variables are used to tie information together by linking records. The specific set of identifiers necessary to properly identify each type of relationship is described in detail in the following sections. Examples of variables that could be used in IDVAR include:
The sequence number (--SEQ) variable, which uniquely identifies a record for a given USUBJID within a domain. The variable --SEQ is required in all domains except Demographics (DM). For example, if subject 1234-2003 has 25 food records in the Food and Water Consumption (FW) domain, FWSEQ values for this subject should be the numbers 1-25. The numbers in the --SEQ variable may not always be represented sequentially in cases where the sponsor assigns the numbers early in the process and subsequently deletes some records or uses blocks of numbers to sequence data coming from different sources, but they should always be unique at least within a subject.
The reference identifier (--REFID) variable can be used to capture an internal or external identifier (e.g., an identifier provided in an electronic data transfer). Some examples are lab-specimen identifiers and slide identifiers. --REFID is permissible in all domains, but never required. Values for --REFID are sponsor- defined and can be any alphanumeric strings the site chooses, consistent with their internal practices.
The grouping identifier (--GRPID) variable, used to link related records for a subject within a dataset, is explained in Section 8.1, Relating Groups of Records Within a Domain Using the --GRPID Variable.
The invariant record identifier (--RECID) variable is described in Example 4 in Section 8.2.2, RELREC Examples for Record-To-Record Relationships.
CDISC Standard for Exchange of Nonclinical Data Implementation Guide: Nonclinical Studies (Version 3.1.1 Final)
Relating Groups of Records Within a Domain Using the --GRPID Variable
The optional grouping identifier variable --GRPID is permissible in all domains that are based on the general observation classes. It is used to identify relationships between records within a USUBJID within a single domain. It is important to note that --GRPID is not the treatment group or the internal specimen ID. An example would be laboratory records for test results from the same sample. In such a case, the relationship is defined by assigning the same unique character value to the --GRPID variable. The values used for --GRPID can be any values the site chooses; however, if the site uses values with some embedded meaning (rather than arbitrary numbers), those values should be consistent across the submission to avoid confusion. It is important to note that --GRPID has no inherent meaning across subjects or across domains.
Using --GRPID in the general observation class datasets can reduce the number of records in the RELREC, SUPP--, and CO datasets when those datasets are submitted to describe relationships or associations for records or values to a "group" of general-observation class records.
The following table illustrates how to use --GRPID in the Laboratory Test Results (LB) domain to identify a combination therapy. In this example, the clinical chemistry results were grouped together from 1 sample for subject ABC-001-001. Note this example does not represent a complete dataset.
lb.xpt
Row | STUDYID | DOMAIN | USUBJID | LBSEQ | LBGRPID | LBTESTCD | LBTEST | LBCAT | LBSCAT | LBORRES | LBORRESU | LBSTRESC | LBSTRESN | LBSTRESU | LBSPEC | LBMETHOD | LBBLFL | LBDTC | LBNOMDY |
1 | ABC | LB | ABC-001- 001 | 1 | 1 | ALB | Albumin | CLINICAL CHEMISTRY | LIVER FUNCTION | 30 | mg/mL | 30 | 30 | mg/mL | SERUM | Y | 2006-07- 19T08:30 | 1 | |
2 | ABC | LB | ABC-001- 001 | 2 | WBC | Leukocytes | HEMATOLOGY | 5.9 | 10^3/uL | 5.9 | 5.9 | 10^3/uL | WHOLE BLOOD | Y | 2006-07- 19T08:30 | 1 | |||
3 | ABC | LB | ABC-001- 001 | 3 | LYMLE | Lymphocytes | HEMATOLOGY | DIFFERENTIAL | 6.7 | % | 6.7 | 6.7 | % | WHOLE BLOOD | Y | 2006-07- 19T08:30 | 1 | ||
4 | ABC | LB | ABC-001- 001 | 4 | NEUT | Neutrophils | HEMATOLOGY | DIFFERENTIAL | 5.1 | 10^3/uL | 5.1 | 5.1 | 10^3/uL | WHOLE BLOOD | Y | 2006-07- 19T08:30 | 1 | ||
5 | ABC | LB | ABC-001- 001 | 5 | PH | pH | URINALYSIS | 7.5 | 7.5 | URINE | Y | 2006-07- 19T08:30 | 1 | ||||||
6 | ABC | LB | ABC-001- 001 | 6 | 1 | CREAT | Creatinine | CLINICAL CHEMISTRY | 0.9 | mg/dL | 79.5618 | 79.5618 | umol/L | SERUM | Y | 2006-07- 19T08:30 | 1 | ||
7 | ABC | LB | ABC-001- 001 | 7 | WBC | Leukocytes | HEMATOLOGY | 5.9 | 10^3/uL | 5.9 | 5.9 | 10^3/uL | WHOLE BLOOD | Y | 2006-07- 19T08:30 | 1 | |||
8 | ABC | LB | ABC-001- 001 | 8 | 1 | CHOL | Cholesterol | CLINICAL CHEMISTRY | 2.29 | mg/dL | 2.29 | 2.29 | mg/dL | SERUM | Y | 2006-07- 19T08:30 | 1 |
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Unique identifier for a study. | Req | |
RDOMAIN | Related Domain Abbreviation | Char | Two-character abbreviation for the domain of the parent record(s). | Req | |
USUBJID | Unique Subject Identifier | Char | Unique Subject Identifier of the Parent record(s). Either USUBJID or POOLID must be populated, except for certain domain-to-domain relationships (see Section 8.2.3). | Exp | |
POOLID | Pool Identifier | Char | Pool Identifier of the Parent record(s). If POOLID is entered, POOLDEF records must exist for each subject and the USUBJID must be null. Either USUBJID or POOLID must be populated. | Perm | |
IDVAR | Identifying Variable | Char | Name of the identifying variable in the general observation class domain that identifies the related record(s). Examples include BWSEQ and BWGRPID. | Req | |
IDVARVAL | Identifying Variable Value | Char | Value of identifying variable described in IDVAR. For example, if BWSEQ is the variable being used to describe this record, then the value of BWSEQ would be entered here. | Exp | |
RELTYPE | Relationship Type | Char | Identifies the hierarchical level of the records in the relationship. Values are only necessary when identifying a relationship between domains (as described in Section 8.4). Values should be either ONE or MANY. | Perm | |
RELID | Relationship Identifier | Char | Unique value within a study that identifies the relationship. RELID can be any value the sponsor chooses and is only meaningful within the df dataset to identify the related/associated domain records. | Req |
Assumptions for Related Records (RELREC) Domain model
The Related Records (RELREC) special-purpose dataset is used to describe relationships between records in different domains and relationships between domains. Relationships represented in RELREC are either:
Collected relationships (e.g., Microscopic Findings to Macroscopic Findings), or
The relationship between Pharmacokinetics Concentrations (PC) and Pharmacokinetics Parameters (PP) records, or
To indicate sponsor-defined identifier (--SPID) values are used consistently within subjects across a set of domains.
A relationship is defined by adding a record to RELREC for each record or group of records to be related and by assigning a unique character identifier value for the relationship (RELID). The value of RELID is chosen by the sponsor, but must be identical for all related records.
Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are populated; RELTYPE is null)
Records expressing a relationship are specified using the key variables STUDYID, RDOMAIN (the 2- letter domain code of the record in the relationship), and USUBJID or POOLID, along with IDVAR and IDVARVAL. Single records can be related by using a unique,record-identifying variable such as -- SEQ in IDVAR. Groups of records can be related by using grouping variables such as --GRPID in IDVAR. IDVARVAL would contain the value of the variable described in IDVAR.
Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL are null; RELTYPE is populated)
The RELREC special-purpose dataset can also be used to identify relationships between datasets (e.g., one-to-many relationship, parent-child relationship). The relationship is defined by including a single
record for each related dataset that identifies the key(s) of the dataset that can be used to relate the respective records.
Records with POOLID populated cannot be included in domain-to domain relationships.
Note that it is not necessary to use the RELREC dataset to identify associations from data in the SUPP-
- datasets or the Comments (CO) domain to their parent general-observation class domain records or special-purpose domain records, as both of these datasets include the key variable identifiers of the parent record(s) that are necessary to make the association.
The variable RELTYPE identifies the type of relationship between the domains. The allowable values are "ONE" and "MANY". This information defines how a merge/join would be written, and what would be the result of the merge/join. The possible combinations are:
ONE and ONE. This combination indicates that there is no hierarchical relationship between the domains and the records in the domains. Only 1 record from each domain will potentially have the same value of the IDVAR within USUBJID.
ONE and MANY. This combination indicates that there is a hierarchical (parent/child) relationship between the domains. One record within USUBJID in the domain identified by RELTYPE = ONE will potentially have the same value of the IDVAR with many (one or more) records in the domain identified by RELTYPE = MANY.
MANY and MANY. This combination is unusual and challenging to manage in a merge/join, and may represent a relationship that was never intended to convey a usable merge/join (e.g., see Section 6.3.12.3, Relating PP Records to PC Records – RELREC is Optional at this Time for SEND).
RELREC Examples for Record-To-Record Relationships
Example 1
This example shows how to use the RELREC dataset to relate records stored in separate domains for subject 123456 who had a clinical sign (rows 1 and 4) that was related to 2 palpable masses (rows 2 and 3) and two microscopic findings (rows 5 and 6).
relrec.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
1 | EFC1234 | CL | 123456 | CLSEQ | 5 | 1 | |
2 | EFC1234 | PM | 123456 | PMSEQ | 11 | 1 | |
3 | EFC1234 | PM | 123456 | PMSEQ | 12 | 1 | |
4 | EFC1234 | CL | 123456 | CLSEQ | 5 | 2 | |
5 | EFC1234 | MI | 123456 | MISEQ | 47 | 2 | |
6 | EFC1234 | MI | 123456 | MISEQ | 48 | 2 |
Example 2
This example shows the relationship between a grouped clinical observation and 2 laboratory results.
relrec.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
1 | EFC1234 | CL | 123456 | CLGRPID | FECES1 | 1 | |
2 | EFC1234 | LB | 123456 | LBSEQ | 47 | 1 | |
3 | EFC1234 | LB | 123456 | LBSEQ | 48 | 1 |
Example 3
This example shows the relationship between a clinical observation for a cage (pool) and 2 laboratory results on individual subjects.
CDISC Standard for Exchange of Nonclinical Data Implementation Guide: Nonclinical Studies (Version 3.1.1 Final)
relrec.xpt
Row | STUDYID | RDOMAIN | USUBJID | POOLID | IDVAR | IDVARVAL | RELTYPE | RELID |
1 | EFC1234 | CL | CAGE1 | CLGRPID | FECES1 | 1 | ||
2 | EFC1234 | LB | B00001 | LBSEQ | 47 | 1 | ||
3 | EFC1234 | LB | B00002 | LBSEQ | 48 | 1 |
Example 4
This example shows how data collection applications should use --RECID to enable downstream applications to create RELREC records that must persist between an initial creation of SEND datasets and subsequent SEND datasets.The variable --RECID is defined in the SDTM, which indicates that it may be added to SEND domains unless the SENDIG restricts it. So, --RECID may be used in most SEND domains, for example in situations where Clinical Observations (CL), Microscopic Findings (MI), Macroscopic Findings (MA), and Palpable Masses (PM) domain records need to be correlated and the following situations exist:
A facility uses one vendor to supply software for their in-life data collection and another vendor to supply software for necropsy and histopathology data collection.
A part of a study (e.g., histopathology) is conducted by a different organization than conducted the in-life and necropsy portions.
In both situations, the correlation between the findings in the different domains must be collected; --RELREC is not supposed to describe correlations made later in the report.
In these situations, software that periodically receives SEND transmissions (e.g., following interim necropsies) cannot rely on the --SEQ variable values on the related records to remain consistent because the standard does not require this. With this use of --RECID, the receiving system is enabled to identify changes between the current transmission and previous ones (if any) and to determine if and how previously established record relationships need to be adjusted.
In this example a gross brain finding of focus/foci, red, is correlated to the microscopic finding of thrombus.
ma.xpt
Row | STUDYID | DOMAIN | USUBJID | MASEQ | MARECID | MATESTCD | MATEST | MAORRES | MASTRESC | MASPEC | MASEV | MADTC |
1 | EFC5678 | MA | ABC-101 | 16 | 046GV2APCIu2 | GROSPATH | Gross Pathological Examination | FOCUS/FOCI, RED, CEREBRUM, MILD, LEFT HEMISPHERE. | FOCUS/FOCI, RED | BRAIN | MILD | 2000-01- 31T14:33:21 |
mi.xpt
Row | STUDYID | DOMAIN | USUBJID | MISEQ | MIRECID | MITESTCD | MITEST | MIORRES | MISTRESC | MISPEC | MISEV | MIDTC |
1 | EFC5678 | MI | ABC-101 | 1 | 2069gT4UnyRR | MIEXAM | Microscopic Examination | BRAIN: Thrombus: subacute, focal, grade 3 | THROMBUS | BRAIN | MODERATE | 2000-01- 31 |
relrec.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELID |
1 | EFC5678 | MA | ABC-101 | MARECID | 046GV2APCIu2 | A |
2 | EFC5678 | MI | ABC-101 | MIRECID | 2069gT4UnyRR | A |
Examples of Domain-To-Domain Relationships for Masses (--SPID)
RELREC Domain-to-Domain Example 1
This example shows how to use the RELREC dataset to represent related information that is submitted as multiple datasets that have an identifying variable in common.
In this example, all the records with the same --SPID across the domains with the same USUBJID are being related to each other. Because this relationship exists for all values of USUBJID and all values of --SPID (specified in IDVARVAL), both USUBJID and IDVARVAL are null.
relrec.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
1 | 999123 | CL | CLSPID | MANY | A | ||
2 | 999123 | MI | MISPID | MANY | A | ||
3 | 999123 | MA | MASPID | MANY | A | ||
4 | 999123 | PM | PMSPID | MANY | A | ||
5 | 999123 | TF | TFSPID | MANY | A |
Because IDVAR identifies the keys that can be used to merge/join records between the datasets, the root values (e.g., --SPID in this example) for IDVAR are the same for all records with the same RELID. --SEQ cannot be used because --SEQ only has meaning within a subject within a domain, not across domains.RELREC --SPID Examples
The following --SPID examples are based on the preceding RELREC dataset. These examples show only the variables from the CL, PM, MA, MI, and Tumor Findings (TF) domains that are relevent to the RELREC discussion. In a submission, additional variables would be included.
RELREC --SPID Example 1
Shows the unique mass number across the 5 domains.
cl.xpt
Row | STUDYID | DOMAIN | USUBJID | CLSEQ | CLSPID |
1 | 999123 | CL | 999123-102 | 56 | MASS A |
pm.xpt
Row | STUDYID | DOMAIN | USUBJID | PMSEQ | PMSPID |
1 | 999123 | PM | 999123-102 | 64 | MASS A |
ma.xpt
Row | STUDYID | DOMAIN | USUBJID | MASEQ | MASPID |
1 | 999123 | MA | 999123-102 | 128 | MASS A |
mi.xpt
Row | STUDYID | DOMAIN | USUBJID | MISEQ | MISPID |
1 | 999123 | MI | 999123-102 | 84 | MASS A |
tf.xpt
Row | STUDYID | DOMAIN | USUBJID | TFSEQ | TFSPID |
1 | 999123 | TF | 999123-102 | 55 | MASS A |
RELREC --SPID Example 2
During the course of the study a mass split into 2 masses; therefore, a new identifier was given to the second mass.
cl.xpt
Row | STUDYID | DOMAIN | USUBJID | CLSEQ | CLSPID |
1 | 999123 | CL | 999123-102 | 56 | MASS A |
pm.xpt
Row | STUDYID | DOMAIN | USUBJID | PMSEQ | PMSPID |
1 | 999123 | PM | 999123-102 | 64 | MASS A |
2 | 999123 | PM | 999123-102 | 228 | MASS B |
ma.xpt
Row | STUDYID | DOMAIN | USUBJID | MASEQ | MASPID |
1 | 999123 | MA | 999123-102 | 128 | MASS A |
2 | 999123 | MA | 999123-102 | 345 | MASS B |
mi.xpt
Row | STUDYID | DOMAIN | USUBJID | MISEQ | MISPID |
1 | 999123 | MI | 999123-102 | 84 | MASS A |
2 | 999123 | MI | 999123-102 | 84 | MASS B |
tf.xpt
Row | STUDYID | DOMAIN | USUBJID | TFSEQ | TFSPID |
1 | 999123 | TF | 999123-102 | 55 | MASS A |
2 | 999123 | TF | 999123-102 | 76 | MASS B |
RELREC --SPID Example 3
During the course of the study 2 masses (mass A and mass B) merge to make a single mass; a new identifier ("MASS C") was given to merged mass.
cl.xpt
Row | STUDYID | DOMAIN | USUBJID | CLSEQ | CLSPID | CLDTC |
1 | 999123 | CL | 999123-102 | 56 | MASS A | 2013-10-01 |
pm.xpt
Row | STUDYID | DOMAIN | USUBJID | PMSEQ | PMSPID | PMDTC |
1 | 999123 | PM | 999123-102 | 64 | MASS A | 2013-10-08 |
2 | 999123 | PM | 999123-102 | 228 | MASS B | 2013-10-08 |
3 | 999123 | PM | 999123-102 | 228 | MASS C | 2013-10-15 |
ma.xpt
Row | STUDYID | DOMAIN | USUBJID | MASEQ | MASPID | MADTC |
1 | 999123 | MA | 999123-102 | 128 | MASS C | 2013-10-22 |
mi.xpt
Row | STUDYID | DOMAIN | USUBJID | MISEQ | MISPID | MIDTC |
1 | 999123 | MI | 999123-102 | 84 | MASS C | 2013-10-22 |
tf.xpt
Row | STUDYID | DOMAIN | USUBJID | TFSEQ | TFSPID | TFDTC |
1 | 999123 | TF | b999123-102 | 55 | MASS C | 2013-10-22 |
Relating Nonstandard Variables Values To a Parent Domain
The SDTM does not allow the addition of new variables. Therefore, the supplemental qualifiers special-purpose dataset model is used to capture nonstandard variables and their association to parent records in general-observation class (Events, Findings, Interventions) datasets and Demographics (DM). Supplemental qualifiers are submitted via
a separate SUPP-- dataset for each domain containing sponsor-defined variables (see Section 8.3, Supplemental Qualifiers - SUPP-- Datasets).
SUPP-- represents the metadata and data for each nonstandard variable/value combination. As the name "supplemental qualifiers" suggests, this dataset is intended to capture additional qualifiers for an observation. Data that represent separate observations should be treated as separate observations, either in this domain or another domain. The supplemental qualifiers dataset is structured similarly to the RELREC dataset in that it uses the same set of keys to identify parent records. Each SUPP-- record also includes the name of the qualifier variable being added (QNAM), the label for the variable (QLABEL), the actual value for each instance or record (QVAL), the origin (QORIG) of the value (see Sections 3.2.2.1, Origin Metadata, and 3.2.3, Value-level Metadata), and the evaluator (QEVAL) to specify the role of the individual assigning the value (e.g., pathologist, veterinarian).
SUPP-- datasets are also used to capture attributions. An attribution is typically an interpretation or subjective classification of 1 or more observations by a specific evaluator (e.g., a diagnosis provided by a pathologist or veterinarian). It is possible that different attributions may be necessary in some cases; SUPP-- provides a mechanism for incorporating as many attributions as are necessary. A SUPP-- dataset can contain both objective data (where values are collected or derived algorithmically) and subjective data (attributions where values are assigned by a person or committee). For objective data, the value in QEVAL will be null. For subjective data, the value in QEVAL should reflect the role of the person assigning the value (e.g., "PATHOLOGIST", "VETERINARIAN").
The values for STUDYID, USUBJID, and POOLID should be unique for every record. There should not be multiple records in a SUPP-- dataset for the same QNAM value, as it relates to IDVAR/IDVARVAL for a USUBJID in a domain.
Just as use of the optional grouping identifier variable, --GRPID, can be a more efficient method of representing relationships in RELREC, it can also be used in a SUPP-- dataset to identify individual qualifier values (SUPP-- records) related to multiple general observation class domain records that could be grouped, such as relating an attribution to a group of laboratory measurements.
Supplemental Qualifiers - SUPP-- Datasets
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Unique study identifier of the parent record(s). | Req | |
RDOMAIN | Related Domain Abbreviation | Char | Two-character abbreviation for the domain of the parent record(s). | Req | |
USUBJID | Unique Subject Identifier | Char | Unique subject identifier of the parent record(s). Either USUBJID or POOLID must be populated. | Exp | |
POOLID | Pool Identifier | Char | Pool identifier of the Parent record(s).. If POOLID is entered, POOLDEF records must exist for each subject and the USUBJID must be null. Either USUBJID or POOLID must be populated. | Perm | |
IDVAR | Identifying Variable | Char | Identifying variable in the dataset that identifies the related record(s). Examples: BWSEQ, CLGRPID. | Exp | |
IDVARVAL | Identifying Variable Value | Char | Value of identifying variable of the parent record(s). | Exp | |
QNAM | Qualifier Variable Name | Char | The short name of the Qualifier variable, which is used as a column name in a domain view with data from the parent domain. The value in QNAM cannot be longer than 8 characters nor can it start with a number (e.g., "1TEST" is not valid). QNAM cannot contain characters other than letters, numbers, or underscores. This will often be the column name in the sponsor's operational dataset. The value in QNAM may not be the same as any variable name defined in another domain or the SDTM. The QNAM should uniquely correspond to a QLABEL within a single domain. | Req |
QLABEL | Qualifier Variable Label | Char | This is the long name or label associated with QNAM. The value in QLABEL should be in title case and cannot be longer than 40 characters. This will often be the column label in the sponsor's operational dataset. | Req | |
QVAL | Data Value | Char | Result of, response to, or value associated with QNAM. A value for this column is required; no records can be in SUPP-- with a null value for QVAL. | Req | |
QORIG | Origin | Char | QORIG is used to indicate the origin of the data. Possible values are COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. See Section 3.2.2.1. | Perm | |
QEVAL | Evaluator | Char | Used only for results that are subjective (i.e., assigned by a person or a group). Should be null for records that contain objectively collected or derived data. Some examples include PATHOLOGIST or VETERINARIAN, etc. | Perm |
A record in a SUPP-- dataset relates back to its parent record(s) via the key identified by the STUDYID, RDOMAIN, USUBJID (or POOLID), and IDVAR/IDVARVAL variables. An exception are SUPP-- dataset records that are related to Demographics (DM) records where both IDVAR and IDVARVAL will be null because the key variables STUDYID, RDOMAIN, and USUBJID (or POOLID) are sufficient to identify the unique parent record in DM (DM has 1 record per USUBJID).
All records in the SUPP-- datasets must have a value for QVAL. Transposing source variables with missing/null values may generate SUPP-- records with null values for QVAL, causing the SUPP-- datasets to be extremely large. When this happens, the sponsor must delete the records where QVAL is null, prior to submission.
If the USUBJID and POOLID are null, then the contents apply to all subjects with the same IDVAR and IDVARVAL.
See Section 4.5.3, Biological Significance for Findings Observation Class Data, for information on representing information greater than 200 characters in length.
Submitting Supplemental Qualifiers
The following examples demonstrate how a set of SUPP-- datasets could be used to relate nonstandard information to a parent domain.
Example 1
In this dataset, parameters of mass size are defined as supplemental information to a subject's necropsy data.
suppma.xpt
Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG | QEVAL |
1 | 1996001 | MA | 199601-101 | MASPID | MASS A | MASSWDTH | Mass Width | 6 mm | COLLECTED | PATHOLOGIST |
2 | 1996001 | MA | 199601-101 | MASPID | MASS A | MASSLGTH | Mass Length | approximately 8 mm | COLLECTED | PATHOLOGIST |
Example 2
In this dataset, the principal investigator has assessed biological significance for 2 samples drawn from a pool of subjects.
supplb.xpt
Row | STUDYID | RDOMAIN | USUBJID | POOLID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG | QEVAL |
1 | ABC | LB | POOLS- 01 | LBSEQ | 1 | BIOSIG | Biological Significance | N | DERIVED | PRINCIPAL INVESTIGATOR | |
2 | ABC | LB | POOLS- 02 | LBSEQ | 6 | BIOSIG | Biological Significance | N | DERIVED | PRINCIPAL INVESTIGATOR |
When Not to Use Supplemental Qualifiers
The following data should not be submitted as supplemental qualifiers:
Subject-level objective data that fit in Subject Characteristics (SC)
Comments related to a record or records contained within a parent dataset. Although they may have been collected in the same record by the sponsor, comments should instead be captured in the CO special- purpose domain.
Data not directly related to records in a parent domain. Such records should instead be captured in either a separate general observation class or special-purpose domain.
Reserved Values for QNAM and QLABEL
Certain QNAM variables have been reserved for specific purposes, as described in previous sections of this document. Those values are as follows:
QNAM | QLABEL | SENDIG Section Reference |
--CALCN | Numeric Interpretation for Calculations | 4.5.1 |
--BIOSIG | Biological Significance | 4.5.4 |
--REAS | Reason Test or Examination Was Performed | 4.5.5 |
--RESMOD | Result Modifiers | 6.3.3, 6.3.7, 6.3.8, 6.3.14 |
Relating Comments to a Parent Domain
The Comments special-purpose domain, which is also described in Section 5.2, Comments, is used to capture unstructured free-text comments. It allows for the submission of comments related to a particular domain or those collected on separate general-comment log-style pages not associated with a domain. Comments may be related to a subject, a domain for a subject, or to specific parent records in any domain. The CO special-purpose domain is structured similarly to the supplemental qualifiers (SUPP--) dataset, in that it uses the same set of keys (STUDYID, RDOMAIN, USUBJID or POOLID, IDVAR, and IDVARVAL) to identify related records. All comments except those collected on log-style pages not associated with a domain are considered child records of subject data captured in domains. STUDYID, USUBJID (or POOLID), and DOMAIN (with the value CO) must always be populated.
RDOMAIN, IDVAR, and IDVARVAL should be populated as follows:
Comments related only to a subject in general would have RDOMAIN, IDVAR, IDVARVAL null, as the only key needed to identify the relationship/association to that subject is USUBJID (or POOLID in the case of comments on a pool of subjects).
Comments related only to a specific domain (and not to any specific record(s)) for a subject would populate RDOMAIN with the domain code for the domain with which they are associated; IDVAR and IDVARVAL would be null.
Comments related to specific domain record(s) for a subject would populate the RDOMAIN, IDVAR, and IDVARVAL variables with values that identify the specific parent record(s).
Additional information may be placed in COREF to further describe the comment's relationship to the parent record. This can only be done if the relationship cannot be represented using the variables RDOMAIN, IDVAR, and IDVARVAL.
As with supplemental qualifiers (SUPP--) and related records (RELREC), --GRPID and other grouping variables can be used as the value in IDVAR to identify comments with relationships to multiple domain records. The limitation on this is that a single comment may only be related to records in 1 domain (RDOMAIN can have only 1 value). If a single comment relates to records in multiple domains, the comment may need to be repeated in the CO special-purpose domain to facilitate the understanding of the relationships.
See Section 5.2.1.2, Examples for Comments (CO) Domain Model.
Relating Findings to Multiple Subjects - Subject Pooling
In nonclinical studies it is common that a single finding may be captured for multiple subjects. The SENDIG specification handles this by introducing pools. The use of a POOLID column has been introduced to the Laboratory
Test Results (LB), Food and Water Consumption (FW), Pharmacokinetics Concentrations (PC), Pharmacokinetics Parameters (PP), and Clinical Observation (CL) domains to support subject pooling in conjunction with the POOLDEF special-purpose domain described in this section.
POOLID and USUBJID are mutually exclusive. When POOLID is used, USUBJID will be null; if a USUBJID is recorded, the POOLID will be null.
It is important to note that POOLID values are unique for a given set of subjects. Although the same value of POOLID may not be re-used to refer to different sets of subjects, different POOLIDs may be used to refer to the same set of subjects.
The following table lists some common examples where pooling may occur.
Because POOLID is unique for a set of subjects, a new POOLID must be generated if the subjects within the pool change. An example of this is when a member of a pool dies, and the number of subjects in the pool is either reduced or a new subject is assigned to that pool. The values of POOLID are sponsor defined. Some examples of POOLIDs include:
A concatenation of subject IDs: "ABC-1001, ABC-1002, ABC-1003, Cage1-1001, Cage2-1002"
Cage identifier and study day: "Cage1-Day 1-Day-27, Cage1-Day-28-54"
Sequential: "POOL1," "POOL2"
Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
POOLID | Pool Identifier | Char | Identifier | Identifier used for pooling subjects to assign a single finding to multiple subjects. | Req | |
USUBJID | Unique Subject Identifier | Char | Identifier | Identifier used to uniquely identify across all studies for all applications or submissions involving the product. | Req |
Assumptions for Pool Definition (POOLDEF) Domain Model
POOLDEF Definition:
This domain identifies the subjects that are included in a pool for which single finding records are captured.
A "pool" must consist of at least 1 subject.
POOLID is unique for a given set of subjects.
Examples for Pool Definition (POOLDEF) Domain Model
Example 1
This example shows pools for group-housed food and water consumption pools and lab results. Rows 1-3: Three subjects exist in pool "CAGE1 P1" for group-housed animals in the FW domain. Rows 4-5: Two subjects were also used for a pooled blood sample in the LB domain.
pooldef.xpt
Row | STUDYID | POOLID | USUBJID |
1 | ABC1 | CAGE1 P1 | ABC1-1001 |
2 | ABC1 | CAGE1 P1 | ABC1-1002 |
3 | ABC1 | CAGE1 P1 | ABC1-1003 |
4 | ABC1 | POOL1 | ABC1-1005 |
5 | ABC1 | POOL1 | ABC1-1007 |
How To Determine Where Data Belong in SEND
Aside from a limited number of special-purpose domains, all subject-level SDTM datasets are based on 1 of the 3 general observation classes. When faced with a set of data that were collected and that "go together" in some sense, the first step is to identify SDTM observations within the data and the general observation class of each observation. Once these observations are identified at a high level, 2 other tasks remain:
Determining whether the relationships between these observations need to be represented using GRPID within a dataset, as described in Section 8.1, Relating Groups of Records Within a Domain Using the -- GRPID Variable, or using RELREC between datasets, as described in Section 8.3, Supplemental Qualifiers
Placing all the data items in 1 of the identified general observation class records, or in a SUPP-- dataset, as described in Section 8.5, Relating Findings To Multiple Subjects - Subject Pooling
In practice, considering the representation of relationships and placing individual data items may lead to reconsidering the identification of observations, so the whole process may require several iterations.
Based on participation on teams and in meetings throughout the development of this version.
SEND Leadership Team | |
Name | Company |
William Houser, SEND Team Leader | Bristol-Myers Squibb |
Fred Wood, Cross-Team Governance | Data Standards Consulting Group |
Mary Jo Brucker, DART Subteam Lead | Merck |
Jamie Gilliam, Change Control Subteam Lead | Instem |
Louis Norton, Cross-team Governance | Covance |
Troy Smyrnios, Cross-team Governance | Zoetis |
Audrey Walker, PCPP Subteam co-lead and Cross-team Governance | Charles River |
Craig Zwickl, Controlled Terminology Subteam Lead | Independent consultant |
SEND Extended Leadership Team | |
Name (with indication of workstream or subteam led where applicable) | Company |
Brian Argo, Dermal Ocular Lead | Charles River |
Kathryn Brown, SENDIG v3.2 Fit for Use Pilot Co-lead | Sanofi |
Susan DeHaven, PhUSE Liaison and SEND for CBER Co-lead | Sanofi |
Marc Ellison, PCPP Co-lead | Instem |
Anthony Fata, CoDEX Co-lead | Altasciences |
Bob Friedman, CoDEX Co-lead | Xybion Corporation |
Matthew Hayes, SENDIG v3.2 Fit for Use Pilot Co-lead | Genentech |
Joseph Horvath, MAMI Co-lead | Bristol-Myers Squibb |
Christy Kubin, Safety Pharm Lead | Charles River |
Debra Oetzman, PCPP Co-lead | Instem |
Daniel Potenta, MAMI Co-lead | PDS LifeSciences |
Ben Sefing | Merck |
Erin Tibbs-Slone | Charles River |
CDISC Leadership Team | |
Chris Gemma, SEND Team Liaison | |
Lou Ann Kramer, SEND Team Liaison | |
SEND V3.1.1 Core Contributors | |
Name | Company |
Lara Marie Castro | Charles River |
David Coutant | Eli Lilly |
Dragomir Draganov | Roche |
Marc Ellison | Instem |
Bob Friedman | Xybion |
Thomas Gade Bjerregaard | Novo Nordisk |
Christy Kubin | Charles River |
Leslie Lorello | Pfizer |
Jayme Morgan | Merck |
Debra Oetzman | Instem |
Erin Tibbs-Slone | Charles River |
Audrey Walker | Charles River |
Michael Wasko | PDS Life Sciences |
Peggy Zorn | Instem |
FDA Advisors | |
Name | |
Paul Brown | |
David Epstein, SEND Leadership Team Liaison | |
Jeffry Florian | |
Lilliam Rosario | |
Kevin Snyder | |
Helena Sviglin | |
Elaine Thompson | |
Kendra Worthy | |
Appendix B: Glossary and Abbreviations
The following abbreviations and terms are used in this document. Additional definitions can be found throughout this document (see, e.g., Section 7.1.2, Definitions of Trial Design Concepts) and in the CDISC Glossary (available at http://www.cdisc.org/glossary/index.html).
CDISC | Clinical Data Interchange Standards Consortium |
CRO | Contract research organization |
CT | Controlled Terminology |
Dataset | A collection of structured data in a single file |
Domain | A collection of observations with a topic-specific commonality |
eCDT | Electronic Common Technical Document |
ECG | Electrocardiogram/electrocardiographic |
eDT | Electronic data transfer |
FDA | (US) Food and Drug Administration |
GLP | Good laboratory practice |
HPLC/MS | High performance liquid chromatography/mass spectrometer |
INHAND | International Harmonization of Nomenclature and Diagnostic Criteria for Lesions in Rats and Mice |
ISO | International Organization for Standardization |
ISO 8601 | ISO character representation of dates, date/times, intervals, and durations of time. The SDTM uses the extended format. |
MRI | Magnetic Resonance Imaging |
NCI | National Cancer Institute (NIH) |
NIH | (US) National Institutes of Health |
SDS | Submission Data Standards. Also the name of the team that created the SDTM and SDTMIG. |
SDTM | Study Data Tabulation Model |
SDTMIG | Study Data Tabulation Model Implementation Guide |
SEND | Standard for Exchange of Nonclinical Data |
SENDIG | Standard for Exchange of Nonclinical Data Implementation Guide |
TK | Toxicokinetics; the study of the absorption, distribution, metabolism and excretion of a drug (synonymous with pharmacokinetics) |
USDA | US Department of Agriculture |
XML | Extensible markup language |
Appendix C: Mapping To tumor.xpt File
The tumor.xpt file is a nonclinical analysis dataset. Specific assumptions regarding tabulating data from carcinogenicity studies were created with the intent that SEND datasets will contain the necessary information to derive a tumor.xpt file. It is the intent of the CDISC SEND Team that the data meet regulatory needs if submitted as SEND datasets.
The following assumptions must be met in to create a tumor.xpt file:
Every subject must have at least 1 record in the Exposure (EX) domain with EXSTDTC populated.
All organs scheduled for examination must have a record in the Microscopic Findings (MI) domain even if they were not analyzed. If a scheduled tissue is not examined, then a record for that tissue should be included with MISTAT = "NOT DONE". In any instance where a sample is found unusable (e.g., autolyzed), MISPCUFL must be "N."
If a sponsor chooses to include secondary or multicentric tumors in the tumor.xpt, they must map METASTATIC to MALIGNANT (=1) for the MALIGNST variable.
If a sponsor does not choose to include secondary or multicentric tumors in the tumor.xpt, the sponsor must exclude records with TFRESCAT = "METASTATIC."
Every tumor (including secondary and/or multicentric tumors) must have 1 record in the Tumor Findings (TF) domain.
Secondary tumors must have a MIRESCAT value of "METASTATIC".
When creating the TF domain, all secondary tumors must contain a value of "MALIGNANT" in the TFRESCAT variable.
TFDETECT (Time in Days to Detection of Tumor) is the number of days from the start of dosing to the earliest detection of the tumor in the experimental phase. This variable must be populated for every tumor discovered during the experimental phase.
The following domains are required in order to create a tumor.xpt file:
Demographics (DM)
Disposition (DS)
Exposure (EX)
Microscopic Findings (MI)
Tumor Findings (TF)
Trial Sets (TX)
Appendix C1: tumor.xpt Mapping to SEND
This table describes the variables in the tumor.xpt and the SEND variables from which they are created.
Tumor Dataset for Statistical Analysis 1,2 (tumor.xpt) | SEND Source - Domain | SEND Source - Variable | SEND Notes | ||||
SDS Variable | SDS Label | SDS Type | SDS Codes | SDS Comments | |||
STUDYNUM | Study number | Char | 3 | TF | STUDYID | This variable is mapped directly from the STUDYID variable in the TF domain. | |
ANIMLNUM | Animal number | Char | 1,3 | DM | USUBJID | This variable is mapped directly from the USUBJID variable in the DM domain. The 12-character limit does not apply. | |
SPECIES | Animal species | Char | M = mouse, R = rat | DM | SPECIES | This variable is mapped from the SPECIES variable in the DM domain. Defined mappings include M: MOUSE | |
Tumor Dataset for Statistical Analysis 1,2 (tumor.xpt) | SEND Source - Domain | SEND Source - Variable | SEND Notes | ||||
SDS Variable | SDS Label | SDS Type | SDS Codes | SDS Comments | |||
and R: RAT. There are no defined mappings for other species. | |||||||
SEX | Sex | Char | M = male, F = female | DM | SEX | This variable is mapped directly from the SEX variable in the DM domain. | |
DOSEGP | Dose group | Num | Use 0, 1, 2, 3, 4,... In ascending order from control. Provide the dosing for each group. | DM -> TX | TXVAL | This variable is mapped from taking the SETCD value for a USUBJID in the DM domain and looking up the TXVAL value in the TX domain when TXPARMCD = "SPGRPCD." It is not required to use 0. | |
DTHSACTM | Time in days to death or sacrifice | Num | DS, EX | DSSTDTC - EXSTDTC + 1 | This variable is calculated as the disposition date minus the first exposure start date for the subject, plus 1. | ||
DTHSACST | Death or sacrifice status | Num | 1 = Natural death or moribund sacrifice 2 = Terminal sacrifice 3 = Planned intermittent sacrifice 4 = Accidental death | DS | DSDECOD | This variable is mapped from the DSDECOD as specified in Table 2 below. | |
ANIMLEXM | Animal microscopic examination code | Num | 0 = No tissues were examined 1 =At least one tissue was examined | MI | MISTAT | This variable is derived from all MI records for the subject. If all MI records for the animal have MISTAT= "NOT DONE," then this variable's value is 0. Otherwise, this variable's value is 1. | |
TUMORCOD | Tumor type code | Char | 3,4 | TFSTRESC Term's Code | The value of this variable is the code from the corresponding TFSTRESC codelist term. | ||
TUMORNAM | Tumor name | Char | 3,4 | TF | TFSTRESC | This variable is mapped directly from the TFSTRESC variable. | |
ORGANCOD | Organ/tissue code | Char | 3,5 | SPEC Term's Code | The value of this variable is the code from the corresponding SPEC codelist term used for the TFSPEC variable. | ||
ORGANNAM | Organ/tissue name | Char | 3,5 | TF | TFSPEC | This variable is mapped directly from the TFSPEC variable. | |
DETECTTM | Time in days to detection of tumor | Num | TF | TFDETECT | This variable is mapped from the TFDETECT variable. | ||
MALIGNST | Malignancy status | Num | 1 = Malignant2 = Benign3 = Undetermined | 4 | TF | TFRESCAT | This variable is mapped from the TFRESCAT as specified in Table 3 below. |
DEATHCAU | Cause of death | Num | 1 = Tumor caused death2 = Tumor did not cause death3 = Undetermined | 4 | TF | TFDTHREL | This variable is mapped from the TFDTHREL variable.1: TUMOR CAUSED DEATH2: TUMOR DID NOT CAUSE DEATH3: UNDETERMINED |
ORGANEXM | Organ/Tissue microscopic examination code | Num | 1 = Organ/Tissue was examined and was usable 2 = Organ/Tissue was examined but was not usable (e.g., autolyzed tissue) 3 = Organ/Tissue was not examined | MI | MISTAT, MISPCUFL | This variable is mapped from the MISTAT and MISPCUFL variables. 1: MISTAT is null and MISPCUFL is null 2: MISPCUFL value is "N" 3: MISTAT = "NOT DONE" and MISPCUFL is null | |
Each subject in the study should have at least 1 record even if it does not have a tumor.
Additional variables, as appropriate, can be added to the bottom of this dataset.
ORGANCOD and TUMORCOD limited to no more than 8 characters; ORGAN and TUMOR should be as concise as possible.
A missing value should be given for the variable MALIGNST, DEATHCAU, TUMOR, and TUMORCOD when the organ is unusable or not examined.
Do not include a record for an organ that was usable and no tumor was found on examination. A record should be included for organs with a tumor, organs found unusable, and organs not examined.
Appendix C2: Mapping DSDECOD to DTHSACST
The tumor.xpt dataset's DTHSACST variable may be mapped from the Disposition (DS) domain's DSDECOD variable. The following table provides DSDECOD values and their DTHSACST equivalent.
DSDECOD | DTHSACST | |
Value | Value | Meaning |
ACCIDENTAL DEATH | 4 | Accidental death |
FOUND DEAD | 1 | Natural death or moribund sacrifice |
MISSING | * | * |
MORIBUND SACRIFICE | 1 | Natural death or moribund sacrifice |
INTERIM SACRIFICE | 3 | Planned intermittent sacrifice |
RECOVERY SACRIFICE | * | * |
REMOVED FROM STUDY ALIVE | * | * |
TERMINAL SACRIFICE | 2 | Terminal sacrifice |
NON-MORIBUND SACRIFICE | * | * |
There are no mappings to the DTHSACST variable for DSDECOD values listed with an asterisk (*). Subjects with these dispositions would not be relevant for tumor analysis.
Appendix C3: Mapping TFRESCAT to MALIGNST
The tumor.xpt dataset’s MALIGNST variable may be mapped from the TFRESCAT variable in the Tumor Findings (TF) domain. The following table provides TFRESCAT values and their MALIGNST equivalent.
TFRESCAT | MALIGNST | ||
Value | Value | Meaning | Notes |
MALIGNANT | 1 | MALIGNANT | |
METASTATIC | 1 | MALIGNANT | If the sponsor chooses to include secondary and multcentric tumors in the tumor.xpt |
BENIGN | 2 | BENIGN | |
UNDETERMINED | 3 | UNDETERMINED | |
Appendix C4: Mapping of SEND Variables to tumor.xpt Variables
Appendix D: Revision History
This appendix lists all revisions since the last production version.
The changes made from SENDIG v3.1 to SENDIG v3.1.1 are as follows:
PC domain
PCBLFL changed to Perm (was Exp)
PCDTC changed to Perm (was Exp)
PCELTM changed to Exp (was Perm)
PCTPTREF changed to Exp (was Perm)
PCUSCHFL added (Perm)
Assumption added to state intended purpose of PC domain
Assumptions rewritten to emphasise importance of PCNOMDY, PCELTM and PCTPTREF in plotting concentration profiles
All existing examples removed and replaced with cross-domain examples, plus 1 PC-specific example of how best to represent an unscheduled concentration sample
PP domain
Assumption added to describe relationship from PP back to PC
Assumption 2 removed
All existing examples removed and replaced with cross-domain examples, plus 1 PP-specific example of how best to qualify AUC tests
Section 6.3.12.3.2, Relating Records, Example 3, Method C, typographical errors corrected in row descriptions
Three cross-domain examples added
Example 1 - EX, PC, PP and SUPPPC showing population of timing variables, when all timing information is readily available electronically
Example 2 - PC, PP and SUPPPC showing population of timing variables, when only the minimum amount of timing information is readily available electronically
Example 3 - PC, PP, SUPPPC and POOLDEF showing population of timing variables for a sparse sampling study.
Dataset-level Metadata
Table 3.2.1 Dataset Definition Metadata Example updated for PC to reflect changes to PC domain definition
Table 3.2.1 Dataset Definition Metadata Example updated for PP to reflect changes to PP domain definition
Section 4.5.1.1 Original and Standardized Results
Updated reference to PC examples for use of SUPP--
Section numbering
Section 6.3.13, PC PP Cross-Domain Examples was inserted, meaning all subsequent sections within
6.3 were re-numbered
Appendix A
BDSYCD
HLT
HLTCD
HLGT
LLT
LLTCD
PARTY
PRTYID
PTCD
SCAN
SCONG
SDISAB
SDTH
SHOSP
SLIFE
SOD
SMIE
SOC
SOCCD
ACTARMCD
ACTARM
COUNTRY
DTHDTC
DTHFL
ETHNIC
INVID
INVNAM
RACE
RFICDTC
RFPENDTC
PRESP
TSVALCD
TSVCDREF
TSVCDVER
Appendix F: Representations and Warranties, Limitations of Liability, and Disclaimers
It is possible that implementation of and compliance with this standard may require use of subject matter covered by patent rights. By publication of this standard, no position is taken with respect to the existence or validity of any claim or of any patent rights in connection therewith. CDISC, including the CDISC Board of Directors, shall not be responsible for identifying patent claims for which a license may be required in order to implement this standard or for conducting inquiries into the legal validity or scope of those patents or patent claims that are brought to its attention.
“CDISC grants open public use of this User Guide (or Final Standards) under CDISC’s copyright.”
Each Participant in the development of this standard shall be deemed to represent, warrant, and covenant, at the time of a Contribution by such Participant (or by its Representative), that to the best of its knowledge and ability: (a) it holds or has the right to grant all relevant licenses to any of its Contributions in all jurisdictions or territories in which it holds relevant intellectual property rights; (b) there are no limits to the Participant’s ability to make the grants, acknowledgments, and agreements herein; and (c) the Contribution does not subject any Contribution, Draft Standard, Final Standard, or implementations thereof, in whole or in part, to licensing obligations with additional restrictions or requirements inconsistent with those set forth in this Policy, or that would require any such Contribution, Final Standard, or implementation, in whole or in part, to be either: (i) disclosed or distributed in source code form; (ii) licensed for the purpose of making derivative works (other than as set forth in Section 4.2 of the CDISC Intellectual Property Policy (“the Policy”)); or (iii) distributed at no charge, except as set forth in Sections 3, 5.1, and 4.2 of the Policy. If a Participant has knowledge that a Contribution made by any Participant or any other party may subject any Contribution, Draft Standard, Final Standard, or implementation, in whole or in part, to one or more of the licensing obligations listed in Section 9.3, such Participant shall give prompt notice of the same to the CDISC President who shall promptly notify all Participants.
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Note: The CDISC Intellectual Property Policy can be found at http://www.cdisc.org/system/files/all/article/application/pdf/cdisc_20ip_20policy_final.pdf