Dataset class is not declared, blocking automated v4.0 mapping

Rule

DEF-002

Category

Define-XML

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

Metadata gap

Applies to

SDTMIG 3.2, 3.3, 3.4

What changes in v4.0

v4.0 leans on machine-readable structure: specification tables now carry a Variable Group column, Variable C-Code and Variable Definition columns taken directly from SDTM v3.0, and new Variable Relationship tables. All of that assumes the observation class is stated.

What to do about it

Populate def:Class for every dataset. Small job, and it is a precondition for any automated conversion tooling — including this scanner giving you a complete answer. Concretely: several v4.0 changes are scoped to an observation class rather than a variable name — --BODSYS and --MODIFY are removed from Findings but retained in Events and Interventions (VAR-026, VAR-027). Without a declared class this report CANNOT evaluate those rules for this dataset, and their absence from your findings is not evidence that the dataset is unaffected.

What the scan can and cannot see

The gap is in the Define-XML itself and is directly visible: the dataset declares no def:Class. This is the rule that reports what the scan cannot see, so it is conclusive about the metadata and says nothing about the data.