Good vs Better SDTM: Limitations as Operational Model
Henry B. Winsor, Mario Widel · 2013
The CDISC SDTM model since 2005 has demonstrated distinct advantages to FDA reviewers when they receive data in this format. SDTM as well as ADaM are mentioned in FDA guidance as highly desirable, so more and more sponsors are including SDTM and ADaM as an integral part of the NDA/BLA/PLA submissions. While some sponsors create and submit these data sets as final products for review, others are trying to use these data sets, in particular SDTM, internally as well as in submissions. While there are distinct advantages to the latter method (fewer steps, a more efficient organization, etc.), there are many challenges that arise and need to be addressed before a sponsor can be in a position to successfully use SDTM internally. This paper addresses these challenges and offers a few proposed strategies that can be used to overcome them.