Applicability: does the new DC domain apply to this study?

Rule

DOM-003

Category

New domains

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 names this as one of its five most significant changes: "the standard was updated to handle situations in which a person acts as a study subject in a single study more than once", adding Demographics for Multiple Participations (DC) as a Special Purpose domain with DCSEQ. Section 5.2 is a new header section covering DM and DC together, and DM's shared assumptions 1, 2, 15 and 16 are new. Subject Elements (SE) assumption 9 was updated to account for gaps between participations, and Subject Visits (SV) gained assumptions on VISITNUM and multiple participations.

What to do about it

Nothing has been detected here; this is a question about the study that the Define-XML cannot answer. Confirm whether this study permitted rescreening or re-enrolment. If it did, the current single-DM representation needs splitting and the SE and SV timing assumptions revisiting, which is a substantial piece of work. If it did not, no action follows beyond SUBJID (ID-001). Whether anyone re-enrolled is a fact about the conduct of the trial and is not visible in dataset metadata.

What the scan can and cannot see

Fires on DM, which every study has, so nothing about this study has been detected. Whether anyone acted as a subject more than once is a fact about the conduct of the trial and appears in no dataset metadata.