Combine unscheduled visits Keep unscheduled visits separate

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UC2 Options

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Pros SV is cleaner Analysis further down more concise Differentiates what really occurred in the visit

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Cons 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 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