SDTM Trial Summary (TS) domain is essential for regulatory submission and is part of FDA rejection criteria.

TS can be complex to implement with guidance spread across SDTMIG, FDA Study Data Technical Conformance Guide (TCG), FDA Technical Rejection Criteria, and numerous terminologies. Interpretation of validation results for TS can also be difficult. In this webinar, Kristin Kelly discusses the minimum set of parameters that should be included in TS and reviews common implementation issues.

If we missed any burning questions or topics, check out the full webinar and slide deck to see if we covered it. If you still have other questions, please feel free to contact us!