Transcription of Study Data Tabulation Model Implementation Guide - W3
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Study Data Tabulation Model Implementation Guide - W3
CDISC SDTM Implementation Guide (SDS Version ) CDISC, 2004. All rights reserved Page 1 Final July 14, 2004 Study Data Tabulation Model Implementation Guide : Human Clinical Trials Prepared by the CDISC Submission Data Standards Team Notes to Readers This is the approved Implementation Guide for Version 1 of the CDISC Study Data Tabulation Model This Implementation Guide comprises version of the Submission Data Standards. Revision History Date Version Summary of Changes 2004-06-25 Document Version Released version reflecting all changes identified during comment periods.
historical background on how to provide metadata descriptions for submission data. The primary goal of the Metadata Model is to provide regulatory reviewers with a clear understanding of the datasets provided in a submission by communicating clear descriptions of the structure, purpose, attributes, and contents of each dataset and dataset variable.
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