VAR-011 · Variables added
DM can adopt CRACE and CETHNIC for as-collected race and ethnicity
- Rule
- VAR-011
- 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 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 values. This DM dataset declares neither.
What to do about it
Optional. If the collected race and ethnicity values were retained (commonly in SUPPDM or in the raw data), CRACE and CETHNIC are where they now belong. If they were discarded at mapping time, note the gap — it cannot be recovered retrospectively, and that is a data-capture fact rather than a conversion task.
What the scan can and cannot see
DM is declared and neither CRACE nor CETHNIC is. Whether the as- collected values still exist to populate them is a data-capture fact this scan cannot see, which is why the remediation offers the "note the gap" branch.
Sources
Every claim above rests on one of these. Where a line is from the public-review draft it says so, because a draft can still move.
- SDTMIG v4.0 public-review draft (exported 2026-02-09), DM specification table — CRACE (Collected Race) and CETHNIC (Collected Ethnicity), both Char, Perm (draft specification text)
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