Study Data Reviewer's Guide

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Revision as of 00:09, 10 April 2012 by ScottBahlavooni (talk | contribs) (Overview & Scope)
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Overview & Scope

CGD-010: define.XML does not adequately document SDTM mapping decisions, sponsor-defined domains, sponsor-defined controlled terminology, and sponsor extensions to CDISC controlled terminology. A standardized Data Guide would help to address this documentation gap. The content of the Data Guide should be standardized and developed jointly between CDER, Industry, and CDISC.

Plans

Milestones

Tasks

Deliverables