Study Data Tabulation Model Implementation Guide - W3

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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. All rights reserved July 14, 2004 Final CONTENTS 1 ORGANIZATION OF THIS RELATIONSHIP TO PRIOR CDISC HOW TO READ THIS Implementation SUBMITTING 2 FUNDAMENTALS OF THE SDTM.

with the data more effectively with less preparation time. Another benefit of the standardized datasets is to support the FDA™s efforts to develop a repository for all submitted trial data and a suite of standard review tools to access, manipulate, and view the tabulations. Use of these data standards is also expected to benefit industry by

  Effectively