The CDISC Study Data Tabulation Model (SDTM): History, Perspective, and Basics

The CDISC (Clinical Data Interchange Standards Consortium) SDTM is a standard for submitting data tabulations to the FDA in support of marketing applications. In July of 2004, this standard became a Study Data Specification (1) referenced in the eCTD Guidance (2). The FDA has announced on several occasions their intention to make the SDTM required by regulation (3-6). This paper/presentation will focus on the SDTM and the SDTMIG (SDTM Implementation Guide: Human Clinical Trials), but will also describe the regulatory climate around the SDTM, and provide an update on recent activities with SEND (Standard for Exchange of Nonclinical Data), an implementation of the SDTM for animal toxicology and pharmacology studies