Branching information may sit where --CBRFL now belongs

Rule

VAR-032

Category

Variables added

Basis

Confirmed Traceable to the published specification text cited below.

Detectability

Define-XML heuristic The Define-XML indicates this, but does not prove it. Treat the finding as a prompt to check, not as a verdict.

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 — marking items presented only because of a conditional branch, so "not asked" is distinguishable from "asked and not answered". This QRS dataset declares no such flag, and this study's Define-XML declares a supplemental qualifier whose name or label refers to branching, skipping or an item not being asked. That is a hint, not a finding: it suggests the study kept branching information somewhere non-standard, and v4.0 gives it a standard column.

What to do about it

Optional, and only possible where the branching information survives in a form that maps to a per-item flag — a supplemental qualifier saying "item skipped" may be per-item, per-form or free text, and only the first converts directly. Check before committing. Where it does convert, the flag materially improves the reviewability of QRS scoring; where it does not, this closes as a documentation note rather than as work.

What the scan can and cannot see

A QNAM or QLABEL naming a branch, a skip or a not-asked state is a proxy for conditional-branching information. It is a weaker proxy than the other two rules in this block, because the vocabulary sponsors use for branching is not standardised — which is exactly why v4.0 adds a standard flag. Nothing here establishes that the flag can be populated.