Data Standards; Requirement Begins for Version 3.1.1 of the Clinical Data Interchange Standards Consortium Standard for Exchange of Nonclinical Data Implementation Guide
Primary source
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Issuing agencies
Abstract
The Food and Drug Administration's (FDA or Agency) Center for Biologics Evaluation and Research and (CBER) and Center for Drug Evaluation and Research (CDER) are announcing the date that support begins for version 3.1.1 of the Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG), 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.
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