SDTMIG v3.1.3


Published Date:

Version 3.1.3 of the Study Data Tabulation Model Implementation Guide (SDTMIG) for Human Clinical Trials corresponds to SDTM version 1.3. Updates to the guide and the model include:

  • Additional variables to the general observation classes for clinical and non-clinical trials
  • Content previously published in the SDTM Amendment 1
  • Changes to the trial design section
  • Document formatting updates
  • TU/TR/RS Oncology domains developed as the Oncology Disease-specific Therapeutic Area Supplement.

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Errata

An erratum (plural: errata) is a correction to a mistake made in a published standard, which was identified after it was published on the CDISC website, and which would have been corrected in the current version had it been identified prior to publication. Updates, revisions, substantive corrections, and other changes of enough significance to require a cycle through the Standards Development Process are not errata, and thus are not included on the pages below.


A known issue is a problem or concern with a CDISC standard that CDISC is aware of, and may be working actively to mitigate or resolve. Unlike errors or errors that affect conformance, known issues have no obvious solution when they are first identified; and some known issues may prove to be irresolvable.