Raw visit number VISITNUM LBDY LBDTC 2 missing 99 17 20140317 3 3 28 20140328 VISIT VISITNUM SVDY SVDTC SVUPDES Week 1 2 14 20140314 Week 1 Unscheduled 17 20140317 ID: 434480
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Slide1
UC3: Complications Related to Unscheduled performed instead scheduled (TK)
Raw visit numberVISITNUMLBDYLBDTC2missing99172014-03-1733282014-03-28
VISITVISITNUMSVDYSVDTCSVUPDESWeek 12142014-03-14 Week 1 Unscheduled172014-03-17Lab TestWeek 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 unscheduled visit?Slide2
UC3: Complications Related to Unscheduled performed instead scheduled (TK) option 1
Raw visit numberVISITNUMLBDYLBDTC2missing2172014-03-1733282014-03-28
VISITVISITNUMSVDYSVDTCSVUPDESWeek 12142014-03-14 Week 1 Unscheduled172014-03-17Lab TestWeek 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 unscheduled visit?Slide3
UC3: Complications Related to Unscheduled performed instead scheduled (TK) option 2
Raw visit numberVISITNUMLBDYLBDTC2missing2.1172014-03-1733282014-03-28
VISITVISITNUMSVDYSVDTCSVUPDESWeek 12142014-03-14 Week 1 Unscheduled2.1172014-03-17Lab TestWeek 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 unscheduled visit?Slide4
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 >ADAMTo use results as Baseline (e.g. Set up of Baseline flag) => Company decision >SDTM IGSlide5
UC2 Pros & Cons
ProsConsArguments as scheduled visitsno lost informationCould overlap with the next visitDifficulty in creation of SV domainSDTM programming and mapping more challenging (e.g. need to include additional result identifier)Potential issue with Open CDISCArguments as unscheduled visitsSV is cleanerdata traceabilityMultiple unscheduled visits possible, including SVDTC populated with the same dateChallenges in further analysis