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Zdrowie i gospodarka · 20.08.2020

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; Correction

The Food and Drug Administration (FDA) is correcting a document that appeared in the Federal Register of July 7, 2020. The document announced 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, and for version 2.1 of the Define-Extensible Markup Language (Define-XML). The document provided the incorrect dates for these electronic study data standards. This document corrects those errors.

Source: Federal Register — Food and Drug AdministrationOpen original release →