Variables developed for nonclinical trials, usable with caution

Rule

VAR-003

Category

Variables changed

Basis

Confirmed Traceable to the published specification text cited below.

Detectability

Protocol required The Define-XML cannot settle this. Answering it needs the protocol or the study design.

Finding type

Question

Applies to

SDTMIG 3.2, 3.3, 3.4

What changes in v4.0

v4.0 Section 3.3, "SDTM Variables Developed for Nonclinical Trials", lists variables that "were developed for use in nonclinical trials and have not been evaluated for use in human clinical trials", and states that "they may be used in human clinical trials, but with caution. Refer to the SENDIG to understand their intended use." Among them are the specimen qualifiers --PORTOT and --ANTREG and the abnormality modifiers --DISTR and --CHRON, all scoped to Findings. This is a caution, not a prohibition: the variables carrying the restriction "Not in human clinical trials" — which must never be used — are a different set, described separately in the same section. The list also names SETCD (scoped to Demographics), POOLID, and AGERLO/AGERHI, which this rule does not match; that is a matter of which rule reports what, not a statement that the caution excludes them.

What to do about it

No change is required by v4.0. Record why the variable is used in a human trial, so a reviewer meeting a nonclinical-origin qualifier can see it was a decision rather than an accident, and check the SENDIG for its intended use if that rationale is not already written down.

What the scan can and cannot see

That the variable is declared in a Findings dataset is conclusive; that is not the finding. Section 3.3 permits these in human trials with caution, so what settles it is the study's own rationale for using a nonclinical-origin qualifier, which no Define-XML carries.