Optional variables added to domains this study already carries

Rule

VAR-034

Category

Variables added

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

Opportunity

Applies to

SDTMIG 3.2, 3.3, 3.4

What changes in v4.0

v4.0 adds twenty Permissible variables to twelve domains that already existed in v3.4. By domain: BE gains BEDY (Study Day of Specimen Collection); BS gains BSLOBXFL and GF gains GFLOBXFL (Last Observation Before Exposure Flag); DS gains DSPARTY (Accountable Party) and DSPRTYID (Identification of Accountable Party); EC gains ECTRTV (Treatment Vehicle), ECVAMT (Treatment Vehicle Amount) and ECVAMTU (Treatment Vehicle Amount Units); EG gains EGANMETH (Analysis Method), EGENDTC (End Date/Time of ECG) and EGENDY (Study Day of End of ECG); FA gains FADIR (Directionality); LB gains LBCNDAGT (Test Condition Agent); MH gains MHSTDY (Study Day of Start of Event) and MHENDY (Study Day of End of Event); MI gains MIBDAGNT (Binding Agent) and MIMRKSTR (Marker String); RP gains RPEVAL (Evaluator) and RPEVALID (Evaluator Identifier); and SR gains SREVALID (Evaluator Identifier). Every one of them is Permissible.

What to do about it

Nothing here is required, and adopting a permissible variable you have no data for is worse than not adopting it — Section 4.2.4 says such a variable "should not be included in the SDTM dataset and should not be declared in the Define-XML document". So the question is narrow: for each domain listed below, did the study collect something these variables would now carry, and is it currently sitting in a supplemental qualifier? If it is, moving it is a genuine improvement and can ride along with the SUPP-to-NS conversion you are doing anyway. If it is not, do nothing and say so.

What the scan can and cannot see

What is established is that these domains are present in this study and that v4.0 adds these variables to them - both settled, one by the Define-XML and one by the specification tables. Whether any of them is worth adopting depends on what the study collected, which no Define-XML shows; that condition sits in the remediation rather than in the claim. Contrast VAR-012, which is `data-required` because its claim is itself scoped to a data condition, "where exact age is unknown".