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
What this record is not
Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
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.
Abstract as published in the Federal Register.
READ THE FULL DOCUMENT
The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.
View on federalregister.gov →That is what FDA published. A free account files it on your watchlist and sends one weekly email with whatever lands next.
Create a free account