UC5:Assigning of Epoch after treatment discontinuation (NS)
Study epochs per protocol:
Randomization,Treatment start
End of treatment,Date of lasttrt
End of study, consent withdraw
UC5: (cont.) subject information
CRF pages: end of treatment, FU, end of studySubject has got 2 cycles. Last TRTDTC=2014-02-01Cycle 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 treatmentSubject 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?
Question
On which level should we handle treatment delay period: EPOCH or ELEMENT?
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.
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.
Definition from CDISC SDTM
“IfTAETORD and/or EPOCH are added, then the values must be thoseat the start of thevisit”Chapter 5, “SV”, P35. 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 planmight 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 thenext treatmentElement. If the subject actually started the next treatment Epoch[see Section 7 - Introduction: 7.1.2, Definitions Of Trial Design Concepts]after4weeks,the sponsor will have to decide whether to represent this as an abnormally long Element, or as a normal Element plus an unplannednon-treatmentElement.Chapter 5, “SE”,P3
Handling on EPOCH level
Study epochs per protocol:
Randomization,Treatment start
End of treatment,Date of lasttrt
End of study, consent withdraw
Epoch Level: Subjecttime axis
RandomizationTreatment start
End of treatment,Date of lasttrt
End of study, consent withdraw
Last treatment2014-02-01
Consent W.2014-03-14
No FU information collected in Original EDC DB
How it looks in thedata (Option 1)
SE
How it looks inthe data (cont.)
LB
SV
DS
Date, where decision to stoptreatment and studywas made (last subject visit)
Date of last medication administration
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?
Element level: Subjecttime axis
RandomizationTreatment start
End of treatment,Date of lasttrt
End of study, consent withdraw
Last treatment2014-02-01
Consent W.2014-03-14
No FU information collected in Original EDC DB
How it looks in thedata (Option 2)
SE
How it looks inthe data (cont.)
LB
SV
DS
Date, where decision to stoptreatment and studywas made (last subject visit)
Date of last medication administration
Questions to team
Can we consider Treatment delay as Unplanned Element if it is acceptable according to ProtocolDo we need to define „FU“ Element /Epoch for this case in SE and other domains?
Questions to FDA
Is variable EPOCH expected in SV and DS domains as well?Isdiscrepancy between scheduled visit number and EPOCH acceptable if described in RG? (considering option 1as for other subjects Cycle 3 will correspond to „TREATMENT“ EPOCH)Would it be acceptable to have EPOCH blank with description in Reviewer Guide?
0
Embed
Upload