Date: June 2 | 11:30 AM–11:50 AM

Location: Momentum Ballroom A

The paper is co-authored by Laura Williams and Andrea Gardani. The findings will be presented by Laura Williams.

It is becoming increasingly more common for clinical studies to allow multiple screenings and/or multiple enrollments for the same subject. There is not well-established guidance from CDISC nor FDA about how these subjects should be handled in SDTM for regulatory submissions. Currently, there is a proposal from CDISC about handling such cases in a special-purpose domain, Demographics as Collected (DC), that could be added to future versions of SDTM. This seems to align with FDA’s suggestions in the Technical Conformance Guide, however FDA does not give formal direction either. However, there are some tips that can be taken from current guidance and used in practice, considering that sponsors should discuss the approach with their FDA reviewer prior to submission. Consider these three possible scenarios: a subject is screened multiple times and fails each time; a subject is screened and fails the first time(s) but upon rescreening is eligible and enrolls; or a subject is enrolled multiple times within the same study. This paper will summarize the current guidance that is available, what is proposed from both CDISC and FDA, and practical examples in SDTM.