--MODIFY is removed from the Findings model

Rule

VAR-027

Category

Variables removed

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

CDISC's public-review material states that --MODIFY was removed from the Findings model. The specification diff provides a directly observable standard-domain example: PEMODIFY is present in the v3.4 Physical Examination table and absent from v4.0, while AEMODIFY, AGMODIFY, BEMODIFY, CMMODIFY, MHMODIFY and SUMODIFY are retained in Events and Interventions. This demonstrates that the change is class-specific rather than variable-name-specific. Because CDISC identifies the change at the Findings model level, a --MODIFY variable present in another dataset classified as Findings should also be treated as impacted by the target Findings-model change.

What to do about it

Review how reported and standardized terms are represented for this Findings dataset under v4.0, particularly where a coding pipeline currently populates --MODIFY. Redesign that representation according to the v4.0 Findings model. If study-specific information remains necessary and no standard v4.0 variable represents it, assess whether it qualifies for representation through the applicable non-standard-variable mechanism. Uses of --MODIFY in Events and Interventions are not affected by this Findings-model removal.

What the scan can and cannot see

As VAR-026: the declared variable plus the declared FINDINGS class settle it, and a dataset with no declared class is reported as an assessment that could not run rather than as a clean result.