| 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 "NDF-RT" stands for "National Drug File - Reference Terminology", It has been replaced by "MED-RT" or "Medication Reference Terminology" as explained here https://evs.nci.nih.gov/ftp1/MED-RT/Introduction%20to%20MED-RT.pdf .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. |