SDTM v1.4


Published Date:

The Study Data Tabulation Model (SDTM) defines a standard structure for study data tabulations that are to be submitted as part of a product application to a regulatory authority. Version 1.4 of SDTM adds variables to the general observation classes for clinical and non-clinical trials.


Files

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SDTMIG v3.2
SDTMIG for Medical Devices v1.0
SDTMIG-AP v1.0
Conformance Rules v1.1 for SDTMIG v3.2 and v3.3
Controlled Terminology Relationships v1.0 for SDTM v1.4 and SDTMIG v3.2

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.