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.

The COVID-19 pandemic had an immense impact on people’s lives. The quick development of effective and safe vaccines as well as their availability are critical to public health.

Clinical trials for vaccines typically collect similar types of data. Preparing this data for submission requires knowledge of specific guidance from regulatory agencies and standards development organizations. In this webinar, Michael Beers reviews FDA, PMDA, and CDISC guidance and other considerations for preparing vaccine studies for regulatory submissions. Also, Michael goes over common problems and inconsistencies seen in data of vaccine studies.