2022-27346: 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; Correction
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The Food and Drug Administration (FDA) is correcting a notice correction that appeared in the Federal Register of August 20, 2020. The document announced the correction dates that the support and requirement were to begin for version 1.7 of the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM), and version 3.3 of the SDTM Implementation Guide (SDTMIG), and for version 2.1 of the Define-Extensible Markup Language (Define-XML). The document erroneously provided the incorrect dates for these electronic study data standards. This document corrects those errors.
The agency’s own summary, as published.
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