1. UC2 Options Pros Cons Combine unscheduled visits SV is cleaner
Analysis further down more concise
Doesn’t differentiate what really occurred in the visit
How to identify the unscheduled visit in EDC
Not shown on graphical representation from FDA
SDTM programming and mapping more challenging
Keep unscheduled visits separate
Differentiates what really occurred in the visit
Multiple unscheduled visits possible, including SVDTC populated with the same date
Combined SVUPDES only achieved if concatenate individual SVUPDES
Could overlap with the next visit
Difficulty in creation of SV domain