NS-003 · Structural
v4.0 does not say what replaces associated-persons SUPP datasets
- Rule
- NS-003
- Category
- Structural
- Basis
- Needs verification Believed correct and not yet confirmed against a citable line of the specification. Treated as provisional until it is.
- 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
Associated-persons datasets are governed by the separate SDTMIG-AP, not by the SDTMIG. The 2026-02-09 v4.0 draft contains no occurrence of "SQAP", so it neither decommissions nor retains the associated-persons supplemental structure by name. It does, however, anticipate the replacement: Section 8.2 and the Relationship assumptions both say that "if the parent record is an observation about an associated person (APID), then APID must be included in the NSAP-- dataset", and the split-domain rules give nsapfamh.xpt as an example dataset name. So an NSAP-- structure is expected to exist, while the document that would define it — the SDTMIG-AP — has not been updated to describe it. The draft says as much without meaning to: where it refers the reader to the SDTMIG-AP for associated persons, the link it gives is to version 1.0, which predates NS-- and knows nothing of it. Whether SDTMIG-AP will follow the SUPP-to-NS move, and on what timetable, remains unanswered.
What to do about it
Do not assume the SDTMIG's SUPP-to-NS conversion transfers here unchanged. The v4.0 draft names an NSAP-- dataset without specifying it, and the specification that would is the SDTMIG-AP. Flag this as an open question and check the SDTMIG-AP roadmap before committing to a design or quoting a client.
What the scan can and cannot see
The dataset is visibly an associated-persons supplemental dataset. What resolves the finding is not in any Define-XML: the SDTMIG-AP has not been updated for the SUPP-to-NS move, and the v4.0 draft names an NSAP-- dataset without specifying 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 public-review draft (exported 2026-02-09) — searched: no occurrence of 'SQAP' in any paragraph or specification table (observed absence, not a statement by CDISC)
- SDTMIG v4.0 public-review draft (exported 2026-02-09), Section 8.2, Non-Standard Variables for [dataset name] (NS--) — 'If the parent record is an observation about an associated person (APID), then APID must be included in the NSAP-- dataset', and the section refers the reader to the SDTMIG-AP (draft specification text)
- SDTMIG v4.0 public-review draft (exported 2026-02-09), Section 4.1.7, Splitting Domains — 'Non-standard variable datasets for split FA datasets would also be split and would be given the prefix of "NS" in the dataset names (e.g., nsfacm.xpt, nsfamh.xpt, nsapfamh.xpt)' — the associated-persons form is named in an example while being specified nowhere (draft specification text)
- SDTMIG v4.0 public-review draft (exported 2026-02-09) — 'Data about associated persons must include APID, SREL, and RSUBJID; see the SDTMIG-AP at https://www.cdisc.org/standards/foundational/sdtmig/sdtmig-ap-v1-0' — the draft's own cross-reference is to SDTMIG-AP v1.0, which predates the NS-- structure (draft specification text)
- SDTMIG: Associated Persons (SDTMIG-AP) v1.0 — the standard that governs associated-persons datasets, not superseded by this IG (external CDISC standard, published; it has not been updated for the SUPP-to-NS change)
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