NS-- dataset name does not resolve to a standard parent domain

Rule

NS-004

Category

Structural

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

Section 8.2 pairs each Non-Standard Variables dataset with one domain dataset — "there is a one-to-one correspondence between a domain dataset and its NS-- dataset" — and names them NS plus the parent domain abbreviation. This dataset carries an NS-- shaped name whose implied parent is not a domain in the SDTMIG v3.4 or v4.0 specification tables, or is a domain those tables classify as a relationship dataset rather than as a domain dataset. Either way the name does not identify a parent the standard defines, so a reviewer cannot resolve it and a conformance check will not either.

What to do about it

Establish which parent domain this dataset belongs to and rename it accordingly. Two innocent explanations are worth ruling out first: the parent may be a Therapeutic Area User Guide or companion-IG domain that this scanner's registry does not carry, in which case the name is fine and this finding is a gap in the registry; or the dataset may not be a non-standard-variables dataset at all and merely start with the letters NS, in which case rename it to something that cannot be read as one. Otherwise it is a genuine naming defect and the parent has to be decided.

What the scan can and cannot see

The dataset name is in the Define-XML and the parent domain code either is or is not in the SDTMIG specification tables. Both halves are settled without reading a record. What the dataset is FOR, and therefore which parent it should have named, is not settled and is not claimed.