Zdrowie i gospodarka · 7.07.2020
Electronic Study Data Submission; Data Standards; Support and Requirement Begin for Study Data Tabulation Model Version 1.7 Implementation Guide 3.3 and for Define-Extensible Markup Language Version 2.1; Requirement Ends for Study Data Tabulation Model Version 1.3 Implementation Guide 3.1.3
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 the dates that support and requirement will begin for version 1.7 of the Clinical Data Interchange Standards Consortium (CDISC) for Study Data Tabulation Model (SDTM) Implementation Guide (IG) 3.3, as well as for version 2.1 of the Define-Extensible Markup Language (Define-XML). CBER and CDER are also announcing the date that support and requirement will end for version 1.3 of the CDISC SDTM IG 3.1.3. The Agency will update the FDA Data Standards Catalog (Catalog) to reflect these changes.