Domain code is not in the SDTMIG v3.4 or v4.0 domain tables

Rule

DOM-004

Category

Domains changed

Basis

Confirmed Traceable to the published specification text cited below.

Detectability

External context required The Define-XML cannot settle this. Answering it needs a decision or a fact held outside the submission metadata.

Finding type

Question

Applies to

SDTMIG 3.2, 3.3, 3.4

What changes in v4.0

Each SDTMIG release absorbs content that sponsors previously carried in custom domains. v4.0 adds DC, GI and EA, and restates that "sponsors may not add any variables other than those described here" and "standard variables must not be renamed or modified for novel usage". What this finding reports is narrower than "this is a custom domain": the domain code is not among the 67 domains defined by the SDTMIG v3.4 and v4.0 specification tables, nor among the companion-IG domains this report also checks. Those tables are a snapshot, not the registry. Section 4.1.6, Dataset Naming, points at the registry — "see the CDISC Controlled Terminology SDTM Domain Abbreviation codelist (DOMAIN) for standard domain codes" — which is versioned, published quarterly, and includes domains from Therapeutic Area User Guides and companion IGs that this report does not check against. A domain from one of those will appear here and is not sponsor-defined.

What to do about it

First establish which kind of dataset this is, because a Define-XML alone cannot. Check the domain code against the current CDISC Controlled Terminology DOMAIN codelist and against the Therapeutic Area User Guides in use on the study. If it is there, this finding tells you only that the code sits outside the SDTMIG's own tables. If it is not, it is a sponsor-defined custom domain: check it against the v4.0 domain list, since retiring a custom domain in favour of a standard one removes a permanent conformance-explanation burden. Section 4.1.6 also notes that domain codes beginning with X, Y or Z are reserved for custom domains, so a code starting with one of those is a custom domain with no further checking needed.

What the scan can and cannot see

That the domain code is absent from the SDTMIG's own domain tables is a fact about those tables. Section 4.1.6 names the CDISC Controlled Terminology DOMAIN codelist as the registry, and that codelist plus the study's Therapeutic Area User Guides decide whether the code is standard or sponsor-defined.