PLANNED VS UNPLANNED
PLANNED VISITS
|
UNPLANNED VISITS
|
Clinical
encounters which are defined by protocol in order to describe assessments
& procedures that are to be performed at visits
|
Unscheduled
visits, not defined in protocol
|
Trial
visits(TV) describes the planned visits in a trial
|
Subject
visits(SV) records unplanned visits
|
VISIT,VISITNUM,VISITDY
are the timing variables
VISITNUM-clinical
encounter number of visit,used for sorting
VISIT-Description
of visit/visit name
VISITDY-Planned
study day of visit
|
VISIT,VISITNUM,--DY
are the timing variables
VISITNUM-decimal
numbering used for inserting unplanned visits
VISIT-May
be left null or populated with generic value(ex:’Unscheduled’)
--DY
–defines the actual study day of an unplanned visit
|
Ex: Visit identifiers
for labdata
USUBJID
|
VISIT
|
VISITNUM
|
VISITDY
|
LBDY
|
001
|
Week1
|
2
|
7
|
7
|
001
|
Week2
|
3
|
14
|
13
|
001
|
Week2
unscheduled
|
3.1
|
17
|