DOM-005 · Domains changed

The PF domain is deprecated in favour of GF

All 47 rules · Catalogue 0.15.2 targeting SDTMIG v4.0 (public-review)

Rule
DOM-005
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
Impact
Applies to
SDTMIG 3.2, 3.3, 3.4

What changes in v4.0

Appendix E records, in the Biospecimen Events (BE) entry, that an example "was updated to refer to the GF domain instead of PF since PF is now deprecated". Pharmacogenomics Findings content moves to Genomics Findings (GF), which was introduced in SDTMIG v3.4.

What to do about it

Remap PF content to the GF domain. Check variable-by-variable rather than assuming a rename — GF was designed against the newer genomics model and the fit will not be one-to-one.

What the scan can and cannot see

A dataset carrying the PF domain is declared, and Appendix E records PF as deprecated in favour of GF. Nothing further is needed to establish that the content has to move.

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.

  1. SDTMIG v4.0 draft (2026-02-09), Appendix E, Section 6.2.2 Biospecimen Events (BE)

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