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STUDY DATA TECHNICAL CONFORMANCE GUIDE Technical Specifications Document This Document is incorporated by reference into the following Guidance Document(s): Guidance for Industry Providing Regulatory Submissions in Electronic Format – Standardized Study Data For questions regarding this technical specifications document, contact CBER at cber-edata@ or CDER at cder-edata@ U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research (CBER) Center for Drug Evaluation and Research (CDER) March 2023 STUDY DATA TECHNICAL CONFORMANCE GUIDE March 2023 Revision History Date Version Summary of Revisions January 2014 1.0 Initial Version Revisions based on the public comment period (February 2014 – May 2014); and CDER/CBER December 2014 2.0 internal review May 2014 – December 2014 Revisions based on comments received to version 2.0. Updates to Sections 2.2 Study Data Reviewer’s Guide (SDRG) March 2015 2.1 SDRG, 2.3 Analysis Data Reviewer’s (ADRG), 3.3.1 SAS Transport Format, 3.3.2. Dataset Size and a revision of Section Data Definition File Revisions based on comments received to version 2.1. Updates on Table of Contents ; Sections