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Zdrowie i gospodarka · 7/18/2022

Data Standards; Requirement Begins for the Clinical Data Interchange Standards Consortium Versions 1.2 and 1.3 of the Analysis Data Model Implementation Guide

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 date that support begins for versions 1.2 and 1.3 of the Clinical Data Interchange Standards Consortium (CDISC) Analysis Data Model Implementation Guide (ADaMIG) and the date that this version update is required in certain submissions. The Agency will update the FDA Data Standards Catalog (Catalog) to reflect these changes.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →