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UC3: Complications Related to Unscheduled performed instead scheduled (TK). Planned lab measurement not performed at day 14, Instead of this measurement on day 17 is performed. LB. Is it still unscheduled visit?. SV. - PowerPoint PPT Presentation
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UC3: Complications Related to Unscheduled performed instead scheduled (TK)
Raw visit number VISITNUM LBDY LBDTC
2 missing
99 17 2014-03-17
3 3 28 2014-03-28
VISIT VISITNUM SVDY SVDTC SVUPDES
Week 1 2 14 2014-03-14
Week 1 Unscheduled 17 2014-03-17 Lab Test
Week 2 3 28 2014-03-28
LB
SV
Planned lab measurement not performed at day 14, Instead of this measurement on day 17 is performed
Is it still unscheduled visit?
UC3: Complications Related to Unscheduled performed instead scheduled (TK) option 1
Raw visit number VISITNUM LBDY LBDTC
2 missing
2 17 2014-03-17
3 3 28 2014-03-28
VISIT VISITNUM SVDY SVDTC SVUPDES
Week 1 2 14 2014-03-14
Week 1 Unscheduled 17 2014-03-17 Lab Test
Week 2 3 28 2014-03-28
LB
SV
Planned lab measurement not performed at day 14, Instead of this measurement on day 17 is performed
Is it still unscheduled visit?
UC3: Complications Related to Unscheduled performed instead scheduled (TK) option 2
Raw visit number VISITNUM LBDY LBDTC
2 missing
2.1 17 2014-03-17
3 3 28 2014-03-28
VISIT VISITNUM SVDY SVDTC SVUPDES
Week 1 2 14 2014-03-14
Week 1 Unscheduled 2.1 17 2014-03-17 Lab Test
Week 2 3 28 2014-03-28
LB
SV
Planned lab measurement not performed at day 14, Instead of this measurement on day 17 is performed
Is it still unscheduled visit?
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
UC2 Pros & ConsPros Cons
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
