Some Limitations of CDISC: SDTM and ADaM as Sponsor Operational Models

• Activity Number: 270
• Type: Invited
• Date/Time: Tuesday, July 31, 2012 : 8:30 AM to 10:20 AM
• Sponsor: Section for Statistical Programmers and Analysts
• Author(s): Mario Widel*+ and Henry B. Winsor
• Companies: Roche Molecular Systems, Inc. and Winsorworks Ltd.
• Keywords: CDISC ; SDTM ; ADaM ; NDA ; PLA ; Operational Model

Abstract

Both SDTM (since 2005) and ADaM (more recently) have demonstrated distinct advantages to FDA reviewers when they receive data in these formats. Both SDTM and 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 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 is going to be in a position to successfully use SDTM and ADaM internally.

This paper addresses these challenges and offers a few proposed strategies that can be used to overcome them.