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Unscheduled Visits and Epoch. User Cases

Unscheduled Visits and Epoch. User Cases. UC1: Complications Related to How to Slot Partial/Missing Dates (CV). LB. EG. SV. UC2: Complications Related to Same Date (CV). LB. EG. Important to differentiate from same date planned visit?. SV. Combined SVUPDES?.

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Unscheduled Visits and Epoch. User Cases

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  1. Unscheduled Visits and Epoch. User Cases

  2. UC1: Complications Related to How to Slot Partial/Missing Dates (CV) LB EG SV

  3. UC2: Complications Related to Same Date (CV) LB EG Important to differentiate from same date planned visit? SV Combined SVUPDES?

  4. 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

  5. UC4: Example Partial Date Problem Assigning Epoch Using Dates (CV) SE Could have started during screening or open label treat. Choose treatment EPOCH CM 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: 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=2014-02-01 • Cycle 3 should start at 2014-02-21, 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 2014-03-14, 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 No FU information collected in Original EDC DB Last treatment 2014-02-01 Consent W. 2014-03-14 LB and EG visit Randomization Treatment start End of treatment, Date of last trt End of study, consent withdraw

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