--BODSYS is removed from the Findings model

Rule

VAR-026

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 --BODSYS was removed from the Findings model. The specification diff provides a directly observable standard-domain example: PEBODSYS is present in the v3.4 Physical Examination table and absent from v4.0, while AEBODSYS and MHBODSYS are retained in Events. This demonstrates that the change is class-specific rather than variable-name-specific. Because CDISC identifies the change at the Findings model level, a --BODSYS 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

Reassess why body-system or organ-class coding is represented in this Findings dataset rather than treating the change as a simple column removal. Redesign the coding and decoding 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. Events-domain uses such as AEBODSYS and MHBODSYS are not affected by this Findings-model removal.

What the scan can and cannot see

Both halves are declared metadata: the variable, and the dataset's FINDINGS class. That pair settles it, because the removal is scoped to the Findings model and Events and Interventions keep the variable unchanged. Where the class is absent this rule reports a coverage gap rather than a silence.