UC5:Assigning of Epoch after
treatment discontinuation (NS)
Study epochs per protocol:
Screening
Treatment
Randomization,
Treatment start
Follow up
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=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?
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 followup.
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
Handling on EPOCH level
Study epochs per protocol:
Screening
Treatment
Randomization,
Treatment start
Follow up
End of treatment,
Date of last trt
End of study,
consent
withdraw
Epoch Level: Subject time axis
No FU information collected in Original EDC DB
Last treatment
2014-02-01
Screening
Treatment
Randomization
Treatment start
End of treatment,
Date of last trt
LB and
EG visit
Consent W.
2014-03-14
Follow up?
End of study,
consent
withdraw
How it looks in the data (Option 1)
SE
ROW
ETCD
SESTDTC
SEENDTC
SEUPDES
EPOCH
2014-01-01
1
SCR
2
TRT
3
FU
2014-01-10
2014-01-10
SCREENING
2014-02-01
TREATMENT
2014-02-01
2014-03-14
FOLLOW UP
How it looks in the data (cont.)
LB
SV
DS
ROW
EPOCH
1
TREATMENT
Cycle 2
2
2014-02-01
2
FOLLOW UP
Cycle 3
3
2014-03-07
ROW
EPOCH
VISIT
VISIT
VISITNUM
VISITNUM SVDY
SVDTC
2014-02-01
1
TREATMENT
Cycle 2
2
2
FOLLOW-UP
3
2014-02-21
3
???
Cycle 3
End of
Treatment
99
2014-03-14
4
FOLLOW-UP
End of Study
999
2014-03-14
ROW
DSCAT
PROTOCOL
MILESTONE
DISPOSITION
EVENT
DISPOSITION
EVENT
1
2
3
DSSCAT
DSDECODE
RANDOMIZATI
ON
END OF
TREATMENT AE
END OF
CONCENT
STUDY
WITHDRAWL
LBDTC
EPOCH
Date, where decision
to stop treatment and
study was made (last
subject visit)
DSSTDTC
SCREENING 2013-11-11
??? 2014-02-01
FOLLOW-UP
2014-03-14
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:
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?
Element level: Subject time axis
No FU information collected in Original EDC DB
Last treatment
2014-02-01
Screening
Treatment
Randomization
Treatment start
LB and
EG visit
Consent W.
2014-03-14
Unplanned SE,
Treatment delay?
End of treatment,
Date of last trt
End of study,
consent
withdraw
How it looks in the data (Option 2)
SE
ROW
ETCD
SESTDTC
SEENDTC
SEUPDES
EPOCH
2014-01-01
1
SCR
2
TRT
3
UNPL
4
FU
2014-01-10
2014-01-10
SCREENING
2014-02-01
TREATMENT
2014-02-01
2014-03-14
2014-03-14
2014-03-14
Treatment
delay TREATMENT
FOLLOW UP
How it looks in the data (cont.)
LB
SV
DS
ROW
EPOCH
1
TREATMENT
Cycle 2
2
2014-02-01
2
TREATMENT
Cycle 3
3
2014-03-07
ROW
EPOCH
VISIT
VISIT
VISITNUM
VISITNUM SVDY
SVDTC
2014-02-01
1
TREATMENT
Cycle 2
2
2
TREATMENT
3
2014-02-21
3
TREATMENT
Cycle 3
End of
Treatment
99
2014-03-14
4
FOLLOW-UP
End of Study
999
2014-03-14
ROW
DSCAT
PROTOCOL
MILESTONE
DISPOSITION
EVENT
DISPOSITION
EVENT
1
2
3
DSSCAT
DSDECODE
RANDOMIZATI
ON
END OF
TREATMENT AE
END OF
CONCENT
STUDY
WITHDRAWL
LBDTC
EPOCH
Date, where decision
to stop treatment and
study was made (last
subject visit)
DSSTDTC
SCREENING 2013-11-11
TREATMENT 2014-02-01
FOLLOW-UP
2014-03-14
Date of last
medication
administration
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?
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?