Data Standards; Support and Requirement Begins for the Clinical Data Interchange Standards Consortium Version 2.0 of the Study Data Tabulation Model, Version 3.4 of the Study Data Tabulation Model Implementation Guide, and Version 1.0 of the Standard for Exchange of Nonclinical Data Implementation Guide-Genetox; Requirement Ends for the Clinical Data Interchange Standards Version 3.2 of the Study Data Tabulation Model Implementation Guide

Issuing agencies

Abstract

The Food and Drug Administration's (FDA or Agency) Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) are announcing that support begins for version 2.0 of the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTMv2.0), version 3.4 of the CDISC Study Data Tabulation Model Implementation Guide (SDTMIGv3.4), and version 1.0 of the Standard for Exchange of Nonclinical Data Implementation Guide-- Genetox (SENDIG-Genetoxv1.0) and announcing the date that these version updates are required in certain submissions. CBER and CDER are also announcing the date that requirement ends for version 3.2 of the CDISC SDTMIG (SDTMIGv3.2). The Agency will update the FDA Data Standards Catalog (Catalog) to reflect these changes. The Agency will publish in the technical specifications document entitled "Study Data Technical Conformance Guide" additional details on how to implement new variables.