**StudySAS Blog: Mastering Clinical Data Management with SAS**

Setting The Record Straight: The Future of ODM, SDTM and CDISC November 05, 2008 By Rebecca Kush, Frank Newby, David Iberson-Hurst, & Amanda J de Montjoie, CDISC When rumors increase, and when there is an abundance of noise and clamor, believe the second report. Alexander Pope, 1688–1744 In recent weeks, there have been a number of rumors about the Clinical Data Interchange Standards Consortium CDISC standards and their continued use by the Food and Drug Administration (FDA). These whispers suggest that the Study Data Tabulation Model (SDTM) standard is being replaced and that the Operational Data Model (ODM) should no longer be used. The rumors have caused confusion at best and fear of standards abandonment at worst. This is a second report—an attempt to clarify what’s happened and how the industry should move forward. CDISC, to state the obvious, is a global standards organization. While the FDA plays a vital role in the drug development industry in the U.S., there are other ...

An Introduction to CDISC: CDISC: Why SAS® Programmers Need to Know CDISC Implementation Step by Step: A Real World Example A Toolkit for CDISC Implementation CDISC standards How to test CDISC Operation data Model (ODM) in SAS Creating Case Report Tabulations (CRTs) for an NDA Electronic Submission to the FDA Implementation Guide Study Data Tabulation Model Update on CDISC Study Data Tabulation Model Practical Methods for Creating CDISC SDTM Domain Data Sets from Existing Data SAS® Dataset Content Conversion to CDISC Data Standards IMPLEMENTATION OF CDISC STANDARDS Sample CRF's and Protocol CRFs (PDF - 773.4 KB) Protocol (PDF - 2.0 MB) direct link: https://biolincc.nhlbi.nih.gov/studies/