Applicability: which Define-XML version does this submission need?

Rule

DEF-001

Category

Process

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 states no Define-XML version requirement. Section 4.1.1 says only that data prepared under the IG "are accompanied by metadata represented in a Define-XML document" and that domain specifications consist of variable metadata "some of which is represented in a Define-XML document"; the 2026-02-09 draft mentions Define-XML in 81 paragraphs and names a version number in none of them. Appendix E records the IG moving further away from the question, removing Define-XML implementation detail from the AE and MH assumptions and from Section 4.9.6 "in an effort to remove Define-XML implementation from the SDTMIG", and Section 3.2 defers to it outright: sponsors "should refer to the Define-XML version used to determine the most appropriate strategy" for planned-but-uncollected data. Nothing here establishes that Define-XML 2.0 cannot represent v4.0 metadata or NS-- datasets, and this scan is not evidence either way. Four different questions decide which version you produce, and only one of them can compel a change: what a version can represent is settled by the Define-XML standard; what you must submit is settled by the receiving agency's data standards catalog; what you can currently produce is settled by your pipeline; and what you choose to standardise on is your own policy.

What to do about it

Treat this as an applicability check, not a defect. Look up the Define-XML versions supported and required in your submission window — for FDA submissions, the Data Standards Catalog states them and the dates they apply from — and compare that against the version this study produces. If the catalog requires a version you do not produce, the upgrade is driven by that requirement and is worth scheduling as its own piece of work ahead of the SDTM conversion, because debugging a metadata pipeline and a data conversion in one release is how both slip. If it does not, nothing in SDTMIG v4.0 asks you to change Define-XML version, and any move you make is a tooling or policy decision with its own rationale.

What the scan can and cannot see

The declared Define-XML version is a fact; which version this submission needs is not in the file. The IG states no requirement, so the answer comes from the receiving agency's data standards catalog, the sponsor's pipeline and the sponsor's own policy.