TIRL is removed from the TI specification table

Rule

VAR-033

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

TIRL (Inclusion/Exclusion Criterion Rule) is removed from the Trial Inclusion/Exclusion Criteria specification table. Appendix E 7.4.1 records it in those words: "TIRL removed. Assumptions 1 and 2 added." TI is otherwise unchanged - the other seven variables carry the same cores in v4.0 as in v3.4 - so this is a single-variable removal rather than a restructuring of the domain.

What to do about it

Decide where the criterion rule text goes and record the decision. v4.0 publishes no target: the two assumptions Appendix E says were added to TI concern the IE- variable prefix and IESCAT for sub-studies, and neither mentions TIRL. So this is a sponsor decision, not a mapping CDISC has specified, and it should be documented as one. TI is a trial-design domain with one record per criterion and no subject data, so the work is contained - but do not let "contained" become "dropped silently", because a machine-readable eligibility rule is the kind of thing a reviewer notices the absence of.

What the scan can and cannot see

The variable is declared in the Define-XML, which is the whole of what this rule needs to see. Whether the criterion rules it carries have a home elsewhere in the sponsor's model is not a metadata question and is not claimed.