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Unscheduled Visits and Epoch. User Cases. UC1: Complications Related to How to Slot Partial/Missing Dates (CV) Raw visit numberVISITNUMLBDYLBDTC 992014-03.

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Presentation on theme: "Unscheduled Visits and Epoch. User Cases. UC1: Complications Related to How to Slot Partial/Missing Dates (CV) Raw visit numberVISITNUMLBDYLBDTC 992014-03."— Presentation transcript:

1 Unscheduled Visits and Epoch. User Cases

2 UC1: Complications Related to How to Slot Partial/Missing Dates (CV) Raw visit numberVISITNUMLBDYLBDTC Raw visit numberVISITNUMEGDYEGDTC 99missing VISITVISITNUMSVDYSVDTCSVUPDES Week Lab Test ECG Test Week 1 Unscheduled Lab Test Week LB EG SV

3 Raw visit numberVISITNUMLBDYLBDTC Raw visit numberVISITNUMEGDYEGDTC VISITVISITNUMSVDYSVDTCSVUPDES Week Week 1 Unscheduled Lab Test Week 1 Unscheduled Lab Test and ECG Test Week UC2: Complications Related to Same Date (CV) LB EG SV Combined SVUPDES? Important to differentiate from same date planned visit?

4 UC3: Complications Related to Unscheduled performed instead scheduled (TK) Raw visit numberVISITNUMLBDYLBDTC 2missing VISITVISITNUMSVDYSVDTCSVUPDES Week Week 1 Unscheduled Lab Test Week 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?

5 UC4: Example Partial Date Problem Assigning Epoch Using Dates (CV) ELEMENTEPOCHSESTDTCSEENDTC ScreenSCREENING Drug XOPEN LABEL TREATMENT Wash OutWASHOUT Drug ABLINDED TREATMENT Second Follow-upFOLLOW-UP SE CMSTDTCEPOCH SCREENING OPEN LABEL TREATMENT FIRST TREATMENT ??? SECOND TREATMENT SECOND FOLLOW-UP CM Could have started during screening or open label treat. Choose treatment EPOCH Unknown. Could have started during open label treat, washout, blinded treat, or follow-up

6 UC5:Assigning of Epoch after treatment discontinuation (NS) Study epochs per protocol: ScreeningTreatmentFollow up Randomization Treatment start End of treatment, Date of last trt End of study, consent withdraw

7 UC5: (cont.) subject information CRF pages: end of treatment, FU, end of study Subject has got 2 cycles. Last TRTDTC= Cycle 3 should start at , but subject has AE, thus treatment delay, No bettering after 14 days, Lab visit, EG Visit performed. => Physician decision to discontinue treatment Subject comes to visit and decide not to go to FU, but to withdraw consent at , so no FU observation and data collection, end of study. Q: Which epoch and VISITNUM to assign to LB and EG visit in delay period?

8 UC5(cont.) Subject time axis ScreeningTreatmentFollow up? Randomization Treatment start End of treatment, Date of last trt End of study, consent withdraw Last treatment Consent W LB and EG visit No FU information collected in Original EDC DB


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