--DRVFL is no longer listed in the FT and QS specifications

Rule

VAR-021

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

--DRVFL (Derived Flag) is present in the v3.4 FT and QS specification tables and absent from the v4.0 ones. The variable itself is untouched: v4.0 carries --DRVFL in eighteen other domains. This is a change to which domains list it, and Section 4.2.4 states the tables list only some of the available variables. The QRS assumption governing QS, FT and RS allows findings general observation class qualifiers generally and lists the qualifiers that "would generally not be used" — --DRVFL is not among them. That is support against reading the table removal as a prohibition, not CDISC permitting --DRVFL in QS or FT by name. The draft separately documents --DRVFL at length, including a worked EGDRVFL example, which establishes that the variable remains part of the standard but says nothing about these two domains specifically. No source explains why the FT and QS tables stopped listing it.

What to do about it

Decide deliberately whether to keep the flag or represent derived status through Define-XML Origin metadata — both are available, and v4.0 does not choose for you. The QRS assumption does not list --DRVFL as an exception, which is support for keeping it rather than a reason it has to go. A flag dropped without information loss is a Define-XML edit, not a conversion. Escalate only where downstream logic keys off the flag.

What the scan can and cannot see

--DRVFL being declared is conclusive; what it means is not. The QRS assumption permits Findings qualifiers generally and does not list --DRVFL among those that would not generally be used, and no source explains the table change. Whether to keep the flag or rely on Define- XML Origin is a sponsor decision.