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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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.

Short Name	"COUNTRY" Terminology Change
Affected Standard	SDTMIG v3.1.2 SDTMIG v3.1.2, Amendment 1 SDTMIG v3.1.3 SDTMIG v3.2
Description of Codelist Change	The SDTMIG v3.2 and earlier versions list the CDISC SDTM codelist "COUNTRY" as the terminology codelist to use for the Demographics domain variable COUNTRY. This codelist was retired in 2016-09-30 (Package 27) because it duplicated the ISO 3166-1 alpha-3 codes for the representation of names of countries and their subdivisions. Maintaining the SDTM "COUNTRY" codelist was not reasonable, since it duplicated content maintained by ISO.
Standard with Codelist Change	SDTMIG v3.3 lists 3166-1 alpha-3 as the codelist for the COUNTRY variable

Affected Variable	Codelist in Published Standard	Replacement Codelist
DM.COUNTRY	CDISC codelist "COUNTRY"	ISO 3166-1 alpha-3

Impact of Issue	Coping Strategy
For submissions using CDISC CT package 27 or later, the CDISC SDTM "COUNTRY" codelist is not present.	Use ISO 3166-1 alpha-3. Click the online browser link from https://www.iso.org/iso-3166-country-codes.html
For submissions using CDISC CT package 27 or later, submission values that were prepared using the CDISC SDTM "COUNTRY" codelist for DM.COUNTRY may not be those in the current version of ISO 3166-1 alpha-3	Most values will be identical, but should be checked.

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

"COUNTRY" Terminology Change

TSPARM "Pharmacological Class" Terminology Change