Collected race or ethnicity may sit where CRACE and CETHNIC now belong

Rule

VAR-030

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 CRACE (Collected Race, Char) and CETHNIC (Collected Ethnicity, Char) to Demographics as Permissible variables, so values as originally collected can travel alongside the standardised RACE and ETHNIC. Before v4.0 there was nowhere standard for them, and the usual home was a supplemental qualifier on DM. This study's Define-XML declares a QNAM naming race or ethnicity, and this DM dataset declares neither CRACE nor CETHNIC — so the content the new variables were designed for appears to exist, in the structure v4.0 is decommissioning.

What to do about it

Optional, and cheaper at conversion time than later. Check what the supplemental qualifier actually holds: where it is the as-collected race or ethnicity value, CRACE and CETHNIC are where v4.0 puts it, and moving it out of the supplemental structure is work the SUPP-to-NS conversion makes you do anyway. Where it is something else that merely mentions race — a free-text comment, a coding note — leave it alone; the match here is on a name, not on content. Nothing about this is required, and both variables are Permissible.

What the scan can and cannot see

Two Define-XML facts and one proxy. DM declaring neither CRACE nor CETHNIC is conclusive; a QNAM naming race or ethnicity is a proxy for what the supplemental dataset holds, and a name is not a value. Whether the collected values are populated is record-level and is not claimed.