The Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG) v3.2 was published in November 2013.
This page lists errata for an older version of the SDTMIG. See SDTMIG v3.3 Errata for errata identified in the latest version of the SDTMIG.
This page contains the working list of errata for the final version 3.2 of the SDTMIG.
Overall: Intra-document cross-references should be changed from bold italic to plain text.
Page 22 (noportfolio page 46) / Section 22.214.171.124, Examples of --STRTPT, --STTPT, --ENRTPT, and --ENTPT, 2. Adverse Events: The final line of this example, "AEENRTPT = "U" ", should be followed by an additional line that reads: "AEENTPT = final subject contact date, e.g., "2006-11-02" "
The second half of this example (starting with "Example when...") as it is currently and as it should be is as follows:
Page 6 (noportfolio page 67) / DM – Examples for the Demographics Domain Model, Example 1: The values in the "SUBJID" column should be changed for each row as follows:
Page 2 (noportfolio page 75) / SE – Specification for the for the Subject Elements Domain Model: TAETORD and EPOCH should come before SESTDTC in the table.
The final six variables in the SE domain, in their current order and in the order they should be in: