DM can adopt AGERLO and AGERHI where exact age is unknown

Rule

VAR-012

Category

Variables added

Basis

Confirmed Traceable to the published specification text cited below.

Detectability

Data required The Define-XML cannot settle this. Answering it needs the datasets themselves.

Finding type

Opportunity

Applies to

SDTMIG 3.2, 3.3, 3.4

What changes in v4.0

v4.0 adds AGERLO (Age Range Lower Limit) and AGERHI (Age Range Upper Limit) to the DM and DC specification tables, both Num and Permissible. Section 3.3, SDTM Variables Developed for Nonclinical Trials, lists them among the variables that "may be used in human clinical trials, but with caution", and says of them: "These variables were developed to more accurately represent the age range when a specific age is unknown. Use in human clinical trials will be rare." That is guidance about when they fit, not a restriction on using them: the variables that "must never be used" in a human trial are the separate set carrying the usage restriction "Not in human clinical trials".

What to do about it

Optional, and the IG expects it to be rare. Only relevant where AGE is genuinely unknown for some subjects and a range was recorded instead. Do not adopt speculatively, and check the SENDIG for the intended use if you do — Section 3.3 asks for that of everything on its list.

What the scan can and cannot see

The absence of AGERLO and AGERHI beside a declared AGE is conclusive, but the finding is scoped "where exact age is unknown", and whether any subject's exact age is unknown is a record-level fact. Classified by the condition the rule reports, not by the condition the selector matches.