CORE-003 · Variables changed
TULOBXFL is relaxed to Permissible in v4.0
- Rule
- CORE-003
- 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
- Opportunity
- Applies to
- SDTMIG 3.2, 3.3, 3.4
What changes in v4.0
The core designation of TULOBXFL (Last Observation Before Exposure Flag) in Tumor Identification moves from Expected in v3.4 to Permissible in v4.0. This is a relaxation: Section 4.2.4 requires an expected variable to appear even as a null column, whereas a permissible variable "should not be included in the SDTM dataset and should not be declared in the Define-XML document" if the study did not collect the underlying item.
What to do about it
No action is required. If TULOBXFL is currently carried as a null column only to satisfy the v3.4 Expected designation, v4.0 lets you drop it — but keeping it is equally valid, so this is worth a decision only if you are already touching TU.
What the scan can and cannot see
TULOBXFL is declared and its core relaxes from Expected to Permissible. Nothing beyond the declaration needs establishing, and nothing is required of the sponsor either way.
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 — 'If a study did not include a data item that would be represented in a permissible variable, then that variable should not be included in the SDTM dataset and should not be declared in the Define-XML document' (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) — TULOBXFL core Exp -> Perm
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.
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