Transcript Unscheduled_Visit_UC..

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
UC3: Complications Related to Unscheduled
performed instead scheduled (TK) option 1
LB
Raw visit number
VISITNUM
LBDY
2
missing
2
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
UC3: Complications Related to Unscheduled
performed instead scheduled (TK) option 2
LB
Raw visit number
VISITNUM
LBDY
2
missing
2.1
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
VISITNUM
SVDY
SVDTC
Week 1
2
14 2014-03-14
Week 1 Unscheduled
2.1
17 2014-03-17
Week 2
3
28 2014-03-28
SVUPDES
Lab Test
Why do we need the result for uscheduled
instead of result for scheduled
• To use results for analysis as results for
scheduled visits (e.g. In summary statistics) =>
decision and derivation of stats >ADAM
• To use results as Baseline (e.g. Set up of
Baseline flag) => Company decision >SDTM IG
UC2 Pros & Cons
Arguments as
scheduled visits
Pros
Cons
•
•
•
•
no lost information
•
Arguments as
unscheduled visits
•
•
SV is cleaner
data traceability
•
•
Could overlap with the next visit
Difficulty in creation of SV domain
SDTM programming and mapping
more challenging (e.g. need to include
additional result identifier)
Potential issue with Open CDISC
Multiple unscheduled visits possible,
including SVDTC populated with the
same date
Challenges in further analysis