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UC5:Assigning of Epoch after treatment discontinuation (NS) Study epochs per protocol: ScreeningTreatmentFollow up Randomization, Treatment start End of.

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Presentation on theme: "UC5:Assigning of Epoch after treatment discontinuation (NS) Study epochs per protocol: ScreeningTreatmentFollow up Randomization, Treatment start End of."— Presentation transcript:

1 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

2 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?

3 Question On which level should we handle treatment delay period: EPOCH or ELEMENT?

4 Definition from CDISC SDTM Epoch: As part of the design of a trial, the planned period of subjects' participation in the trial is divided into Epochs. Each Epoch is a period of time that serves a purpose in the trial as a whole. That purpose will be at the level of the primary objectives of the trial. Typically, the purpose of an Epoch will be to expose subjects to a treatment, or to prepare for such a treatment period (e.g., determine subject eligibility, wash out previous treatments) or to gather data on subjects after a treatment has ended.

5 Definition from CDISC SDTM Element: An Element is a basic building block in the trial design. It involves administering a planned intervention, which may be treatment or no treatment, during a period of time. Elements for which the planned intervention is "no treatment" would include Elements for screening, washout, and follow- up.

6 Definition from CDISC SDTM “If TAETORD and/or EPOCH are added, then the values must be those at the start of the visit” Chapter 5, “SV”, P3 5. Judgment will also have to be used in deciding how to represent a subject's experience if an Element does not proceed or end as planned. For instance, the plan might identify a trial Element which is to start with the first of a series of 5 daily doses and end after 1 week, when the subject transitions to the next treatment Element. If the subject actually started the next treatment Epoch [see Section 7 - Introduction: 7.1.2, Definitions Of Trial Design Concepts] after 4 weeks, the sponsor will have to decide whether to represent this as an abnormally long Element, or as a normal Element plus an unplanned non-treatment Element. Chapter 5, “SE”, P3

7 Handling on EPOCH level Study epochs per protocol: ScreeningTreatmentFollow up Randomization, Treatment start End of treatment, Date of last trt End of study, consent withdraw

8 Epoch Level: 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

9 How it looks in the data (Option 1) ROWETCDSESTDTCSEENDTCSEUPDESEPOCH 1SCR SCREENING 2TRT TREATMENT 3FU FOLLOW UP SE

10 How it looks in the data (cont.) ROWEPOCHVISITVISITNUMLBDTC 1TREATMENTCycle FOLLOW UPCycle ROWEPOCHVISITVISITNUMSVDYSVDTC 1TREATMENTCycle FOLLOW-UPCycle ??? End of Treatment FOLLOW-UPEnd of Study LB SV ROWDSCATDSSCATDSDECODEEPOCHDSSTDTC 1 PROTOCOL MILESTONE RANDOMIZATI ONSCREENING DISPOSITION EVENT END OF TREATMENTAE??? DISPOSITION EVENT END OF STUDY CONCENT WITHDRAWL FOLLOW-UP DS Date, where decision to stop treatment and study was made (last subject visit) Date of last medication administration

11 Question to team How to populate EPOCH for „End of Treatment“ (SV obs 3, and DS obs 2) for that case: 1.„FOLLOW UP“ in SV and DS (discrepancy with protocol schedule and SDTM IG as end of treament closed to treatment epoch)? 2.„TREATMENT“ in SV and DS (discrepancy by date and sorting order for SV, discrepancy to SE)? 3.„FOLLOW UP“ in SV and „TREATMENT“ in DS (agreement with SE based on date, but different EPOCH description for same event)? 4.Leave blank?

12 Element level: Subject time axis ScreeningTreatment Unplanned SE, Treatment delay? 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

13 How it looks in the data (Option 2) ROWETCDSESTDTCSEENDTCSEUPDESEPOCH 1SCR SCREENING 2TRT TREATMENT 3UNPL Treatment delayTREATMENT 4FU FOLLOW UP SE

14 How it looks in the data (cont.) ROWEPOCHVISITVISITNUMLBDTC 1TREATMENTCycle TREATMENTCycle ROWEPOCHVISITVISITNUMSVDYSVDTC 1TREATMENTCycle TREATMENTCycle TREATMENT End of Treatment FOLLOW-UPEnd of Study LB SV ROWDSCATDSSCATDSDECODEEPOCHDSSTDTC 1 PROTOCOL MILESTONE RANDOMIZATI ONSCREENING DISPOSITION EVENT END OF TREATMENTAETREATMENT DISPOSITION EVENT END OF STUDY CONCENT WITHDRAWL FOLLOW-UP DS Date, where decision to stop treatment and study was made (last subject visit) Date of last medication administration

15 Questions to team Can we consider Treatment delay as Unplanned Element if it is acceptable according to Protocol Do we need to define „FU“ Element /Epoch for this case in SE and other domains?

16 Questions to FDA Is variable EPOCH expected in SV and DS domains as well? Is discrepancy between scheduled visit number and EPOCH acceptable if described in RG? ( considering option 1 as for other subjects Cycle 3 will correspond to „TREATMENT“ EPOCH ) Would it be acceptable to have EPOCH blank with description in Reviewer Guide?


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