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 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".