Transcript Unscheduled Visits. User Cases

Unscheduled Visits and Epoch.
User Cases
UC1: Complications Related to How to
Slot Partial/Missing Dates (CV)
LB
Raw visit number
EG
VISITNUM
LBDY
LBDTC
99
2014-03
99
17 2014-03-17
Raw visit number
VISITNUM
EGDY
EGDTC
99
SV
missing
VISIT
Week 1
VISITNUM
2
SVDY
SVDTC
SVUPDES
13 2014-03-13
2014-03
Lab Test
ECG Test
Week 1 Unscheduled
Week 2
17 2014-03-17
3
20 2014-03-20
Lab Test
UC2: Complications Related to Same
Date (CV)
LB
EG
Raw visit number
VISITNUM
LBDY
99
13 2014-03-13
99
17 2014-03-17
Raw visit number
VISITNUM
EGDY
99
SV
LBDTC
EGDTC
17 2014-03-17
VISIT
VISITNUM
SVDY
SVDTC
SVUPDES
Week 1
2
13 2014-03-13
Week 1 Unscheduled
2.01
13 2014-03-13
Lab Test
Week 1 Unscheduled
2.02
17 2014-03-17
Lab Test and
ECG Test
Week 2
3
20 2014-03-20
Important to
differentiate
from same
date
planned
visit?
Combined
SVUPDES?
UC3: Complications Related to Unscheduled
performed instead scheduled (TK)
LB
Raw visit number
VISITNUM
LBDY
2
missing
99
17 2014-03-17
3
3
Planned lab
measurement not
performed at day
14, Instead of
this measurement
on day 17 is
performed
LBDTC
28 2014-03-28
Is it still
unschedul
ed visit?
SV
VISIT
Week 1
VISITNUM
2
Week 1 Unscheduled
Week 2
SVDY
SVDTC
14 2014-03-14
17 2014-03-17
3
SVUPDES
28 2014-03-28
Lab Test
UC4: Example Partial Date Problem
Assigning Epoch Using Dates (CV)
SE Screen
ELEMENT
EPOCH
SCREENING
Drug X
OPEN LABEL TREATMENT
Wash Out
WASHOUT
Drug A
BLINDED TREATMENT
Second Follow-up FOLLOW-UP
CM
CMSTDTC
2007-05-28
2007-05
2007-06-02
2007-06
2007-06-24
2007-07
SESTDTC
SEENDTC
2007-05-28
2007-05-29
2007-06-10
2007-06-21
2007-06-28
2007-05-29
2007-06-10
2007-06-21
2007-06-28
2007-07-03
EPOCH
SCREENING
OPEN LABEL TREATMENT
FIRST TREATMENT
???
SECOND TREATMENT
SECOND FOLLOW-UP
Could have
started during
screening or open
label treat.
Choose treatment
EPOCH
Unknown. Could
have started
during open label
treat, washout,
blinded treat, or
follow-up
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?
UC5(cont.) 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