TSPARM "Pharmacological Class" Terminology Change

Short Name
TSPARM "Pharmacological Class" Terminology Change
Affected Standard
SDTMIG v3.1.3
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"NDF-RT" stands for "National Drug File - Reference Terminology", It has been replaced by "MED-RT" or "Medication Reference Terminology" as explained here https://evs.nci.nih.gov/ftp1/MED-RT/Introduction%20to%20MED-RT.pdf .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

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.