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Comment: Added erratum for DM.COUNTRY


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DocumentStudy Data Tabulation Model Implementation Guide for Human Clinical Trials
Short NameSDTMIG
Version3.3
ReleasedNovember 2018



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The Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG) v3.3 was published in November 2018.

This page contains the working list of errata for the final version 3.3 of the SDTMIG. These corrections will be incorporated into the next version of the document.

Section 3.2.1, Dataset-Level Metadata

  • In the for for TI, in the value for Structure, "crierion" should be changed to "criterion".

Section 5.2, Demographics

  • DM – Specification: The value in the "Controlled Terms, Codelist or Format" column for COUNTRY should be changed from "ISO 3166-1 Alpha-3" to "ISO 3166-1 alpha-3".

Section 7.4.1, Trial Inclusion/Exclusion Criteria

  • TI – Specification: In the table title, "crierion" should be changed to "criterion".

Section 7.4.2, Trial Summary

  • TS – Examples, Example 1: The value for TSVCDREF in row 27 should be changed from "EUDRAC" to "EUDRACT". 

Appendix E, Revision History

  • In the "Change" column for Section 6.3.16, Tumor/Lesion Domains, "TU and TI" should be changed to "TU and TR".