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

8. Epoch Level: Subject time axis
No FU information collected in Original EDC DB
Last treatment
Consent W.
Screening
Treatment
Follow up?
LB and EG visit
Randomization
Treatment start
End of treatment,
Date of last trt
End of study, consent withdraw

9. How it looks in the data (Option 1)SE
ROW
ETCD
SESTDTC
SEENDTC
SEUPDES
EPOCH 1
SCR
SCREENING 2
TRT
TREATMENT 3 FU
FOLLOW UP

10. How it looks in the data (cont.)
ROW
EPOCH
VISIT
VISITNUM
LBDTC 1
TREATMENT
Cycle 2 2
FOLLOW UP
Cycle 3 3 LB
ROW
EPOCH
VISIT
VISITNUM
SVDY
SVDTC 1
TREATMENT
Cycle 2 2
FOLLOW-UP
Cycle 3 3
???
End of Treatment 99 4
End of Study
999 SV
Date, where decision to stop treatment and study was made (last subject visit)
ROW
DSCAT
DSSCAT
DSDECODE
EPOCH
DSSTDTC 1
PROTOCOL MILESTONE
RANDOMIZATION
SCREENING 2
DISPOSITION EVENT
END OF TREATMENT AE
??? 3
END OF STUDY
CONCENT WITHDRAWL
FOLLOW-UP DS
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:
„FOLLOW UP“ in SV and DS (discrepancy with protocol schedule and SDTM IG as end of treament closed to treatment epoch)?
„TREATMENT“ in SV and DS (discrepancy by date and sorting order for SV, discrepancy to SE)?
„FOLLOW UP“ in SV and „TREATMENT“ in DS (agreement with SE based on date, but different EPOCH description for same event)?
Leave blank?

12. Element level: Subject time axis
No FU information collected in Original EDC DB
Last treatment
Consent W.
Screening
Treatment
Unplanned SE, Treatment delay?
LB and EG visit
Randomization
Treatment start
End of treatment,
Date of last trt
End of study, consent withdraw

13. How it looks in the data (Option 2)SE
ROW
ETCD
SESTDTC
SEENDTC
SEUPDES
EPOCH 1
SCR
SCREENING 2
TRT
TREATMENT 3
UNPL
Treatment delay 4 FU
FOLLOW UP

14. How it looks in the data (cont.)
ROW
EPOCH
VISIT
VISITNUM
LBDTC 1
TREATMENT
Cycle 2 2
Cycle 3 3 LB
ROW
EPOCH
VISIT
VISITNUM
SVDY
SVDTC 1
TREATMENT
Cycle 2 2
Cycle 3 3
End of Treatment 99 4
FOLLOW-UP
End of Study
999 SV
Date, where decision to stop treatment and study was made (last subject visit)
ROW
DSCAT
DSSCAT
DSDECODE
EPOCH
DSSTDTC 1
PROTOCOL MILESTONE
RANDOMIZATION
SCREENING 2
DISPOSITION EVENT
END OF TREATMENT AE
TREATMENT 3
END OF STUDY
CONCENT WITHDRAWL
FOLLOW-UP DS
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?