Study Data Technical Conformance Guide

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CDER SBIA Webinar - Optimizing Your Study Data Submissions to FDA –Study Data Technical Conformance Guide October 2017 Version Update – Nov. 8, 2017

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Provisional Translation (as of July 2015) * * This English version of the Japanese Notification is provided for reference purposes only. In the event of

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In 2014, the FDA published its first official list of validation rules for CDISC SDTM study data standards. These rules cover both conformance and quality

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3.3.1 Lot Distribution Data 3.4.1 Study Reports This eCTD Technical Conformance Guide (Guide) provides specifications,

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Technical Conformance Guide on Electronic Study Data Submissions A Comparative Table After Revision Before Revision 1. Introduction Omitted 1.

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