ID-001 · Variables added
SUBJID is added to every subject-level domain specification table
- Rule
- ID-001
- 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
Appendix E states that "SUBJID (Subject Identifier) has been added to the domain specification tables for all subject level domains throughout the IG to account for multiple subject participations". SUBJID becomes an identifier available across classes rather than a DM-only variable.
What to do about it
Add SUBJID to subject-level domains where it is absent. Mechanically cheap — the value already exists in DM — but it touches every domain, so do it as one sweep rather than domain by domain.
What the scan can and cannot see
A declared subject-level class with no SUBJID column is a Define-XML fact. It is still an opportunity rather than an impact: v4.0 lists SUBJID as Permissible in all but two of the tables that gained it.
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 draft (2026-02-09), Appendix E, 'A note on the addition of SUBJID'
- Mechanically observed specification tables, SDTMIG v4.0 public-review draft (2026-02-09) — SUBJID appears in 55 of the 66 v4.0 domain tables, Permissible in 53 and Required in DM and DC; carried in the versioned standards registry (packages/core/src/standards)
Does this one apply to your studies?
Open the scanner, then select or drop in a Define-XML file. It checks this rule and the other 46 in your browser; the file is never uploaded.
Open the scanner