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.

submitted for human clinical trials. The SDTM, which should be read before this Implementation Guide, describes a general conceptual model for representing clinical study data that is submitted to regulatory authorities. SDS V3.1 provides specific domain models, assumptions, business rules, and examples for preparing standard datasets that are

  Guide, Study, Clinical, Clinical study