CM can adopt the CMTRTCD standardised medication code

Rule

VAR-013

Category

Variables added

Basis

Confirmed Traceable to the published specification text cited below.

Detectability

Define-XML conclusive The Define-XML settles this one way or the other. No further evidence is needed to know whether it applies.

Finding type

Opportunity

Applies to

SDTMIG 3.2, 3.3, 3.4

What changes in v4.0

v4.0 adds CMTRTCD (Standardized Medication Code, Char, Permissible) to Concomitant Medications, giving coded therapy identification a first-class home. Appendix E describes it in Section 4.9.2.2, WHODrug Coding, as "the variable for the code associated with --DECOD". The exact name is CMTRTCD, not a generic --TRTCD root across domains. This dataset does not declare it.

What to do about it

Optional. For a legacy study there is nothing to do. For a study still running, CMTRTCD is where the WHODrug code belongs, rather than a supplemental qualifier — which is worth doing on its own terms, since that supplemental qualifier has to be converted to a non-standard variable otherwise.

What the scan can and cannot see

CM is declared and CMTRTCD is not. Whether a WHODrug code exists to put in it - commonly in a supplemental qualifier today - is not visible here.