Codelists for FA Test Names and Test Codes

Short Name	Codelists for FA Test Names and Test Codes
Affected Standard	SDTMIG v3.2
Description of Codelist Change	The domain specification specifies a codelist "FATEST" for the variable FATEST and a codelist "FATESTCD" for the variable "FATESTCD". However, the FATEST and FATESTCD codelists were removed in the 2016-09-30 version of the SDTM Controlled Terminology. In that and later releases of controlled terminology, therapeutic area-based codelists for the variables FATEST and FATESTCD were included.
Standard with Codelist Change	The SDTMIG v3.3 indicates, with an asterisk, that for FATEST and FATESTCD, "the variable may be subject to controlled terminology." (Versions of the SDTMIG before v3.2 also included an asterisk for these variables.) In SDTMIG v3.3, the CDISC Notes for FATEST and FATESTCD include include the statement, "Note that controlled terminology is in several therapeutic area-specific codelists."

Affected Variable	Codelist in Published Standard	Replacement Codelist
FA.FATEST	CDISC Codelist "FATEST"	One of several codelists with names formatted as "Findings about <therapeutic area> Test Name
FA.FATESTCD	CDISC Codelist "FATESTCD"	One of several codelists with names formatted as "Findings about <therapeutic area> Test Code"

Impact of Issue	Coping Strategy
For submissions prepared using SDTMIG v3.2 that use the 2016-09-30 or later releases of CDISC CT,the "FATEST" and "FATESTCD" codelists are not present in CDISC CT.	Use values in therapeutic area-specific test name and test code lists, where applicable.
Therapeutic area-specific test name and test code lists may not exist for the therapeutic area of a study.	Use values from therapeutic area-specific test name and test code lists, where the definition fits the data collected, even if the study is in a different therapeutic area. Note that the Define-XML document can list only one codelist for a variable, so if terminology is drawn from more than one codelist, the sponsor would have to choose one CDISC codelist and treat values not in that published codelist as extended values, or treat the codelist as a sponsor-defined codelist.

Impact of Issue

Coping Strategy

For submissions prepared using SDTMIG v3.2 that use the 2016-09-30 or later releases of CDISC CT,the "FATEST" and "FATESTCD" codelists are not present in CDISC CT.

Use values in therapeutic area-specific test name and test code lists, where applicable.

Therapeutic area-specific test name and test code lists may not exist for the therapeutic area of a study.

Use values from therapeutic area-specific test name and test code lists, where the definition fits the data collected, even if the study is in a different therapeutic area. Note that the Define-XML document can list only one codelist for a variable, so if terminology is drawn from more than one codelist, the sponsor would have to choose one CDISC codelist and treat values not in that published codelist as extended values, or treat the codelist as a sponsor-defined codelist.