The NS-- dataset name for this SUPP-- dataset cannot be established

Rule

NS-009

Category

Structural

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

SDTMIG v4.0 names an NS-- dataset after the dataset it belongs to. Section 4.1.6 states that "NS is the prefix used in naming non-standard variable datasets", and Section 4.1.7 covers the split case in its own words - "Non-standard variables associated with a split dataset are in a dataset named with the prefix 'NS' followed by the name of the split dataset (e.g., NSLBCH or NSFACM)" - so the name is built from the PARENT DATASET name, not from its two-character domain code. For this dataset that rule does not reach an answer. Either the parent is associated-person data, where Section 4.1.7 refers the reader to the SDTMIG-AP and that document is still at v1.0 and predates NS-- entirely; or the name implies a split parent dataset that this Define-XML does not declare, so the split cannot be confirmed and neither the split name nor the unsplit one can be asserted.

What to do about it

Convert the dataset as NS-001 and NS-002 describe — that part is not in question — and settle the NAME deliberately rather than by convention. Establish the parent dataset this supplemental data belongs to, including any split suffix, and name the NS-- dataset after it. Where the parent is an associated-persons dataset, there is nothing published to follow: track the SDTMIG-AP republication, and record the interim decision and its reason in the reviewer's guide, because a reviewer meeting an unspecified dataset name needs to see that it was chosen rather than assumed.

What the scan can and cannot see

That this dataset is supplemental and must be converted is conclusive from the Define-XML. What the resulting dataset is CALLED is not answerable from metadata here: it depends either on a companion IG that has not been republished, or on a parent dataset this document does not declare.