SDTMIG v3.1.3

Published Date: 16 July 2012

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.

Files

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Errata

Errors that Affect Conformance

Short Name	TSPARM "Pharmacological Class" Terminology Change
Affected Standard	SDTMIG v3.1.3 SDTMIG v3.2
Description of Codelist Change	The SDTMIG, in an appendix and in a Trial Summary (TS) Example, "NDF-RT" is given as the terminology to be used for TSVAL when TSPARMCD = "PCLAS". "NDF-RT" stands for "National Drug File - Reference Terminology", It has been replaced by "MED-RT" or "Medication Reference Terminology" as explained here https://evs.nci.nih.gov/ftp1/MED-RT/Introduction%20to%20MED-RT.pdf . The FDA Data Standards Catalog, 2018-12-19 and later versions, specified "MED-RT" as the terminology to be used for TSVAL when TSPARMCD = "PCLAS".
Standard with Codelist Change	The codelist was corrected in SDTMIG v3.3.

Affected Variable	Codelist in Published Standard	Replacement Codelist
TS.TSVAL when TS.TSPARMCD = "PCLAS"	NDF-RT	MED-RT

Impact of Issue	Coping Strategy
For data that has not been coded, the NDF-RT codelist is no longer available.	Use the MED-RT codelist instead.
Data values taken from the NDF-RT codelist may not be present in the MED-RF codelist.	Most code values are probably the same, but should be checked.

SDTMIG v3.1.3

Files

Errata

SDTMIG v3.1.3

Errors that Affect Conformance

TSPARM "Pharmacological Class" Terminology Change