DOM-001 · New domains
New GI domain collides with an existing sponsor-defined GI dataset
- Rule
- DOM-001
- Category
- New domains
- 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
v4.0 adds Gastrointestinal System Findings (GI) as a standard Findings domain, listed in Appendix E's New Domains table.
What to do about it
Reconcile the existing GI dataset against the standard GI domain. If the sponsor content does not fit, it must be renamed and the mapping reworked; if it does fit, this is a cheap conformance win worth advertising.
What the scan can and cannot see
A dataset named GI is declared and v4.0 defines GI as a standard Findings domain. The name collision is a metadata fact; whether the sponsor content fits the standard domain is the work that follows from 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, New Domains for SDTMIG v4.0
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.
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