Domain code uses a prefix the IG reserves for custom domains

Rule

DOM-007

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

Question

Applies to

SDTMIG 3.2, 3.3, 3.4

What changes in v4.0

Section 4.1.6 states that "domain codes beginning with the letters X, Y, and Z have been reserved for the creation of custom domains". This dataset uses one, so it is a sponsor-defined custom domain by construction — no lookup against the CDISC Controlled Terminology DOMAIN codelist is needed, which is what separates this finding from DOM-004's. Each SDTMIG release absorbs content sponsors previously carried in custom domains, and v4.0 adds DC, GI and EA, so the question worth asking of any custom domain at a version boundary is whether the standard has caught up with it.

What to do about it

Check this dataset's content against the v4.0 domain list, and in particular against DC, GI and EA. Retiring a custom domain in favour of a standard one removes a permanent conformance-explanation burden, which is usually worth more than the one-off remap costs. If nothing in v4.0 fits, nothing has to change — a custom domain on a reserved prefix is legitimate and correctly named, and this finding closes as "reviewed, still custom".

What the scan can and cannot see

Section 4.1.6 reserves domain codes beginning X, Y and Z for custom domains, so a code beginning with one of them is sponsor-defined without anything further being checked. That is settled. What the dataset holds, and whether a v4.0 standard domain would now hold it, is not.