QRS domains can adopt the --CBRFL conditionally branched item flag

Rule

VAR-015

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 a Conditionally Branched Item Flag to the Questionnaires, Ratings and Scales domains: QSCBRFL, FTCBRFL and RSCBRFL, all Char and Permissible. It marks items presented only because of a conditional branch, distinguishing "not asked" from "asked and not answered". This dataset does not declare its domain's flag.

What to do about it

Optional, and only possible where the EDC branching metadata survives — the flag cannot be reconstructed from the submitted data alone. Where it does survive, it materially improves the reviewability of QRS scoring, so it is usually worth doing for a study still running.

What the scan can and cannot see

The QRS dataset is declared without its domain's --CBRFL. Whether the flag can be populated depends on EDC branching metadata surviving, which is outside both the Define-XML and the submitted data.