The Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for
Devices and Radiological Health (CDRH) are announcing the end of support for the 3.1.1. version of Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) Implementation Guide (SDTM IG 3.1.1.). SDTM IG 3.1.2, which has been available since October 2009, is the newer standard supported by FDA. Support for SDTM IG 3.1.1 will end on January 28, 2015.


Posted on the FDA website on 29 January 2013