VAR-017 · Variables added
SV gains SVSEQ
- Rule
- VAR-017
- 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
- Impact
- Applies to
- SDTMIG 3.2, 3.3, 3.4
What changes in v4.0
Appendix E records that Subject Visits gained "assumptions regarding VISITNUM and multiple participations, SVUPDES, and new variable SVSEQ", with examples updated to include SVSEQ.
What to do about it
Add and populate SVSEQ. Straightforward on its own, but it travels with the multiple-participation changes, so do it alongside the DC assessment.
What the scan can and cannot see
SV is declared and SVSEQ is not. Unlike the Permissible additions around it, SVSEQ is required in v4.0, which is why this is an impact rather than an opportunity.
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, Section 5.5 Subject Visits (SV)
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