Study Data Tabulation Model Implementation Guide

← Back to document page

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.

  Guide, Model, Study, Data, Implementation, Tabulation, Study data tabulation model implementation guide