DV can adopt the new DVCLASI deviation classification

Rule

VAR-010

Category

Variables added

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

Opportunity

Applies to

SDTMIG 3.2, 3.3, 3.4

What changes in v4.0

v4.0 adds DVCLASI (Classification of Protocol Deviation, Char, Permissible) to the Protocol Deviations domain. Appendix E records that "Assumption 3 was added to describe the usage of the new variable DVCLASI" and "Assumption 4 was added to specify the usage of the variable DVCAT". This dataset does not declare DVCLASI. Nothing requires it to.

What to do about it

Optional. If the sponsor already records an importance classification — usually in SUPPDV or in DVCAT free text — DVCLASI is where it now belongs, and DVCAT should be re-aligned to the revised assumption at the same time. If no such classification was collected, there is nothing to do.

What the scan can and cannot see

DV is declared and DVCLASI is not, which is the condition reported. Whether the deviation content warrants a classification is a sponsor decision, and nothing is required either way.