CORE-001 · Variables changed
--SPEC is Expected in v4.0 but absent from this dataset
- Rule
- CORE-001
- Category
- Variables changed
- 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
- 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
In v4.0 the core designation of --SPEC (Specimen Material Type) is Expected in exactly six specimen-based Findings domains: BS, CP, GF, IS, LB and MB. In each of the six it was Permissible in v3.4; every other domain carrying --SPEC either did not change (MS Perm, PC and PP Exp), loosened rather than tightened (MI, Req to Exp), or lost the variable from its table altogether (SR, which VAR-029 covers). Section 4.2.4 states that an expected variable must appear in the dataset even when the study did not collect the data item, as a null column with a comment in the Define-XML explaining the absence. This dataset declares no --SPEC column at all, which is the one thing about an expected variable a Define-XML can settle: whether the column is declared. Whether a declared column is adequately populated is a question about the data, and no Define-XML of any version answers it.
What to do about it
Add the --SPEC column to this dataset. Populate it where specimen type was collected; where it was not, include the column null and add the Define-XML comment that Section 4.2.4 requires, which is a documentation task rather than a data one. Do not invent a specimen type to fill it — an uncollected data item is a capture gap to record, not a value to derive. Where --SPEC is already declared this rule stays silent, which is not an assurance that the column is adequately populated; that check needs the data.
What the scan can and cannot see
Section 4.2.4 requires an expected variable's column to be present even where the study has no such data, so a declared domain with no --SPEC column is the condition itself. Whether a column that IS declared is adequately populated is invisible to Define-XML and is not claimed.
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), Section 4.2.4, SDTM Core Designations — 'When the study does not include the data item for an expected variable, however, a null column must still be included in the dataset, and a comment must be included in the Define-XML document to state that the study does not include the data item' (draft specification text; locator corrected in 0.4.1 — previously cited as Section 3.1)
- Mechanically observed specification-table diff, SDTMIG v3.4 (2022-07-21) vs SDTMIG v4.0 public-review draft (2026-02-09) — --SPEC core Perm -> Exp in BS, CP, GF, IS, LB and MB only; MI Req -> Exp; MS Perm -> Perm; PC and PP Exp -> Exp; SR absent from the v4.0 table
- SDTMIG v4.0 public-review draft (exported 2026-02-09), Appendix E, Section 4.8.20.1 Specimen-related Variables — 'New section describing the use of the --SPEC (Specimen Material Type), --SPCUFL (Specimen Usability Flag) and --SPCCND (Specimen Condition) variables'; the core change itself is not narrated in Appendix E, only observable in the tables
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