DOM-006 · Domains changed
The Comments (CO) structure text does not match the v4.0 structure
- Rule
- DOM-006
- Category
- Domains changed
- 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
- Impact
- Applies to
- SDTMIG 3.2, 3.3, 3.4
What changes in v4.0
Appendix E records that CO's structure was updated to "One record per comment per subject of observation", USUBJID Core was changed from Required to Expected, and POOLID and SPDEVID were added as Permissible. This dataset's declared structure is not the v4.0 wording, so the Define-XML statement of what a CO record represents is out of date. The Core change is a separate matter and is not detectable from a Define-XML: no Define-XML version represents Required/Expected/Permissible at all.
What to do about it
Update the CO dataset structure text in the Define-XML to "One record per comment per subject of observation". While you are there, re-check the USUBJID designation against the v4.0 CO specification, which this scan cannot see, and consider whether POOLID or SPDEVID apply. Low effort, but a stale structure string is a conformance finding if left.
What the scan can and cannot see
The structure text is carried in the Define-XML itself (ItemGroupDef/@def:Structure), so a stale one is directly visible. The USUBJID core change recorded in the same Appendix E entry is NOT visible in any Define-XML and is deliberately not reported as detected.
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), Appendix E, Section 5.1 Comments (CO) — 'Structure was updated to "One record per comment per subject of observation". USUBJID Core was changed from "Req" to "Exp". POOLID and SPDEVID were added as "Perm"'
- SDTMIG v4.0 public-review draft (exported 2026-02-09), Section 4.1.1, Dataset and Variable Metadata and the Define-XML document — dataset metadata is a line of the form '<Dataset Name>, <Dataset Label> – <Class>. <Structure>, <Purpose>.' (draft specification text)
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