--TSTDTL is no longer listed in the MS, OE and UR specifications

Rule

VAR-020

Category

Variables demoted

Basis

Draft Read from the public-review draft. The draft can still change before v4.0 is final, and this rule changes with it.

Detectability

External context required The Define-XML cannot settle this. Answering it needs a decision or a fact held outside the submission metadata.

Finding type

Question

Applies to

SDTMIG 3.2, 3.3, 3.4

What changes in v4.0

--TSTDTL (Measurement, Test or Examination Detail) is present in the v3.4 MS, OE and UR specification tables and absent from the v4.0 ones. It is not gone from the standard: v4.0 continues to carry GFTSTDTL, ISTSTDTL, MBTSTDTL and MITSTDTL, documented and exemplified. What changed is which domains list it, and Section 4.2.4 states that the tables list only some of the variables available, all of which remain permissible unless a usage restriction or a domain assumption prohibits them. The v4.0 draft states no such prohibition for --TSTDTL, and Appendix E marks the OE and UR sections "Unchanged". The domain assumptions point the same way without settling it: each of the three allows Findings general observation class qualifiers generally, and none identifies --TSTDTL among the qualifiers that "would not generally be used". That is supporting evidence against reading the table removal as a prohibition; it is not CDISC permitting --TSTDTL in these domains by name. No source explains why the three tables stopped listing it.

What to do about it

Do not drop the variable solely because it left the specification table. Record in the reviewer's guide why a variable outside the domain specification is present, noting that the domain assumption allows Findings qualifiers generally and does not list --TSTDTL as an exception. If you would rather not rely on that, the alternatives are --TEST/--TESTCD granularity or a non-standard variable in NSMS/NSOE/NSUR — but neither is required by anything the draft says. The absence of any migration guidance for --TSTDTL is itself worth a public-review comment.

What the scan can and cannot see

The declared variable is a Define-XML fact; whether keeping it is acceptable is not. No source explains why the MS, OE and UR tables stopped listing --TSTDTL, SDTM v3.0's usage restrictions are not published, and the domain assumptions permit Findings qualifiers as a category without naming this variable. Absence from a table is not a prohibition.