FDA Webview

Free FDA Notices

CDER/CBER Push 3.2 Version of E-Data Interchange Standards


Federal Register Notice: CBER and CDER are announcing support for the 3.2 version of Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model Implementation Guide (SDTM IG 3.2), an update to the FDA Data Standards Catalog, and availability of validation rules for the 3.2 version. SDTM IG 3.2 has been available from CDISC since 12/2013. FDA is encouraging sponsors and applicants to use SDTM IG 3.2 (see section II. Exceptions) in investigational study data provided in regulatory submissions to CBER and to CDER. To view this notice, click here.