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:
Unscheduled Visits and Epoch. User Cases
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
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?
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?
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
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
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?
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