Operational Data Sets to SDTM Data Sets: Narrowing the Gap, a Practical Review

• Activity Number: 324
• Type: Invited
• Date/Time: Tuesday, August 3, 2010 : 10:30 AM to 12:20 PM
• Sponsor: Section for Statistical Programmers and Analysts
• Author(s): Dan Crawford*+
• Companies: Octagon Research Solutions, Inc.
• Keywords: CDISC ; SDTM ; ADaM ; Data Standards

Abstract

Historically, SDTM was never meant to be an operational database, it was created to be used in a data warehouse for FDA. A comprehensive review of the challenges the structure presents and how to overcome them when designing CRFs and databases will be investigated. Practical applications of how to narrow the gap when making the transition from operational datasets to submission compliant datasets will be also discussed. Similarly, SDTM and ADaM vary greatly in both structure and content; however both are needed when submitting to the FDA. An overview of both models will be explored, including the differences in structure, content, and the profile of reviewers at the agency who will utilize each data model.