Introducing Your CDISC SDTM and ADaM Data with a Reviewer's Guide: A Practical Overview

• Activity Number: 346
• Type: Contributed
• Date/Time: Tuesday, July 31, 2012 : 10:30 AM to 12:20 PM
• Sponsor: Section for Statistical Programmers and Analysts
• Author(s): Steven R Kirby*+
• Companies: ViroPharma Inc.
• Keywords: CDISC ; SDTM ; ADaM ; FDA ; SUBMISSION ; SAS

Abstract

One of the key goals of submitting CDISC data supported by define data documentation to the FDA is to enable efficient review. Combining CDISC SDTM or ADaM data with a define document nicely supports review, but leaves out some content (such as an overview of custom and supplemental domains and an explanation of any conformance issues) needed for efficient use of the data by a reviewer. The FDA has increasingly emphasized that useful content not covered by the data or define document should be added to the submission package in a "Reviewer's Guide," and has provided some general guidelines on what is expected. The presenter will highlight types of information that should be considered for inclusion in Reviewer's Guides and will provide examples showing how they can be effectively produced.