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Study Data Tabulation Model Implementation Guide: Human Clinical Trials Ve r s i o n (Final) Prepared by the CDISC Submission Data Standards Team Revision History Date Version 2018-11-20 Final 2013-11-26 Final 2012-07-16 Final 2008-11-12 Final 2005-08-26 Final 2004-07-14 See Appendix F f or Representations and Warranties, Limitations of Liability, and Disclaimers. Notes to Readers This is the Implementation guide for Human clinical trials corresponding to Version of the CDISC Study Data Tabulation Model . CDISC Study Data Tabulation Model Implementation Guide: Human Clinical Trials (Version Final) 2018 Clinical Data Interchange Standards Consortium, Inc.
3.1 standard metadata for dataset contents and attributes..... 17 3.2 U SING THE CDISC D OMAIN M ODELS IN R EGULATORY S UBMISSIONS — D ATASET M ETADATA 17
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