Awesome-SEND
Links
Tools
- sendigR - Enable Cross-Study Analysis of CDISC SEND Datasets
- SENDsanitizer
- xptcleaner
- haven
- read xpt file
Guidance
- ICH - guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceutical M3(R2)
- FDA - M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
SEND Related paper
- Making sense of SEND; the Standard for Exchange of Nonclinical Data
- The Standard for the Exchange of Nonclinical Data (SEND): Challenges and Promises
- Leveraging the Value of CDISC SEND Data Sets for Cross-Study Analysis: Incidence of Microscopic Findings in Control Animals
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SEND harmonization & cross-study analysis: A proposal to better harvest the value from SEND data
- Specific pathologist responses for Standard for Exchange of Nonclinical Data (SEND)
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Regulatory Forum Commentary*: Through the Looking Glass SENDing the Pathology Data We Have INHAND
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Data Standardization, Pharmaceutical Drug Development, and the 3Rs
- The Evolution of SEND at AstraZeneca
PHUSE Working Groups
Books
Blogs
- SEND Dataset QC: Best Practices & Recommendations
- Understanding CDISC SEND Data and How to Be Compliant
- Non-Clinical (SEND) Reference Guide for Clinical (SDTM) Programmers
- Using NCI controlled terminology for standardizing data
YouTube
- Overview of Non-clinical Assessment in Drug Development
- Most Common Issues with CDISC-SEND Data in FDA Toxicology Review
- Leveraging CDISC SEND Data Sets for Study Analyses
- Certara SEND Webinar Series Session #1
- Data Visualization with SEND Data to See What Happened at the Preclinical Phase
- What’s New for SEND 2023 Webinar
presentations
- FDA Study Data Technical Rejection Criteria (TRC): What you need to know!