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Study Data Tabulation Model Implementation Guide

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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. 2004-07-14 Document Version Corrects minor typos and errors in sections , , , , , , CDISC SDTM Implementation Guide (SDS Version ) Page 2 CDISC, 2004.

5.1.2 Comments Domain Model Š CO.....37 5.1.2.0 Assumptions for Comments (CM) domain model.....39 6 DOMAIN MODELS BASED ON THE GENERAL CLASSES.....40 6.1 INTERVENTIONS ...

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