VAR-029 · Variables demoted
SRSPEC is no longer listed in the SR specification
- Rule
- VAR-029
- Category
- Variables demoted
- Basis
- Draft Read from the public-review draft. The draft can still change before v4.0 is final, and this rule changes with it.
- 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
SRSPEC (Specimen Type) is present in the v3.4 Skin Response specification table and absent from the v4.0 one. --SPEC is unaffected as a variable and appears in ten v4.0 domains, several of which tightened its core to Expected. Unlike the other rules in this section, the v4.0 SR domain assumption addresses the variable directly: it names --SPEC among the qualifiers that "would not generally be used" in SR. That is guidance about applicability, not a prohibition — Section 4.2.5 states that such a list "is informative only and does not mean the listed variables cannot be included in the domain". So CDISC does not expect specimen type in SR, and does not forbid it.
What to do about it
This one carries more signal than the rest of this section, so treat it as a design question rather than a formality: CDISC does not expect specimen type in SR. Decide where it is best represented for your data — retained in SR, which remains allowed, linked through RELSPEC where the specimen is described elsewhere, or omitted if the study never captured it. Record the decision and the reason. Do not remove a populated SRSPEC on the strength of an assumption the IG itself labels informative.
What the scan can and cannot see
SRSPEC being declared is a Define-XML fact. The SR assumption naming --SPEC among qualifiers that "would not generally be used" is guidance about applicability, and Section 4.2.5 states such a list is informative only - so nothing here establishes a prohibition, a removal, or a required change. Where specimen type is best represented is a design decision.
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 draft (2026-02-09), SR domain assumptions — --SPEC is named among qualifiers that would not generally be used in SR
- SDTMIG v4.0 public-review draft (exported 2026-02-09), Section 4.2.5, Inclusion of Variables not in the Domain Specification — 'Each domain has an assumption listing variables the SDS team thought unlikely to be needed for data in the domain, but the list is informative only and does not mean the listed variables cannot be included in the domain' (draft specification text; locator corrected in 0.4.1 — previously cited as Section 3.1)
- SDTMIG v4.0 public-review draft (exported 2026-02-09), Section 4.2.4, SDTM Core Designations — 'Although domain specification tables list only some of the identifier, timing, and general observation class variables listed in the SDTM, all are permissible unless prohibited by SDTM usage restrictions or by specific domain assumptions' (draft specification text; locator corrected in 0.4.1 — previously cited as Section 3.1)
- SDTMIG v3.4 vs v4.0 specification-table diff (SR) — --SPEC retained in 10 v4.0 domains
Does this one apply to your studies?
Open the scanner, then select or drop in a Define-XML file. It checks this rule and the other 46 in your browser; the file is never uploaded.
Open the scanner