Transcription of Study Data Tabulation Model Implementation Guide
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Study Data Tabulation Model Implementation Guide
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.
Tabulation datasets, which describe the essential data collected in a clinical trial, are one of four types of data currently submitted to the FDA along with patient profiles, listings, and analysis files.
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