1. UC3: Complications Related to Unscheduled performed instead scheduled (TK) Raw visit numberVISITNUMLBDYLBDTC 2missing 99172014-03-17 33282014-03-28 VISITVISITNUMSVDYSVDTCSVUPDES Week 12142014-03-14 Week 1 Unscheduled172014-03-17Lab Test Week 23282014-03-28 LB SV Planned lab measurement not performed at day 14, Instead of this measurement on day 17 is performed Is it still unschedul ed visit?

2. UC3: Complications Related to Unscheduled performed instead scheduled (TK) option 1 Raw visit numberVISITNUMLBDYLBDTC 2missing 2172014-03-17 33282014-03-28 VISITVISITNUMSVDYSVDTCSVUPDES Week 12142014-03-14 Week 1 Unscheduled172014-03-17Lab Test Week 23282014-03-28 LB SV Planned lab measurement not performed at day 14, Instead of this measurement on day 17 is performed Is it still unschedul ed visit?

3. UC3: Complications Related to Unscheduled performed instead scheduled (TK) option 2 Raw visit numberVISITNUMLBDYLBDTC 2missing 2.1172014-03-17 33282014-03-28 VISITVISITNUMSVDYSVDTCSVUPDES Week 12142014-03-14 Week 1 Unscheduled2.1172014-03-17Lab Test Week 23282014-03-28 LB SV Planned lab measurement not performed at day 14, Instead of this measurement on day 17 is performed Is it still unschedul ed visit?

4. Why do we need the result for uscheduled instead of result for scheduled To use results for analysis as results for scheduled visits (e.g. In summary statistics) => decision and derivation of stats >ADAM To use results as Baseline (e.g. Set up of Baseline flag) => Company decision >SDTM IG

5. UC2 Pros & Cons ProsCons Arguments as scheduled visits no lost information Could overlap with the next visit Difficulty in creation of SV domain SDTM programming and mapping more challenging (e.g. need to include additional result identifier) Potential issue with Open CDISC Arguments as unscheduled visits SV is cleaner data traceability Multiple unscheduled visits possible, including SVDTC populated with the same date Challenges in further analysis