The following diagram represents visits as numbered "flags" with visit numbers. Each flag has 2 supports, one at the beginning of the visit and the other at the end of the visit. Note that visits 2 and 3 span epoch transitions. In other words, the transition event that marks the beginning of the run-in epoch (confirmation of eligibility) occurs during visit 2, and the transition event that marks the beginning of the study product administration epoch (the first study product administration of the study tobacco product) occurs during visit 3.
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Two TV datasets are shown for this trial. The first shows a somewhat idealized situation, where the protocol has provided specific timings for the visits. The second shows a more common situation, where the timings have been described only loosely.
tv.xpt
tv.xpt
Row
STUDYID
DOMAIN
VISITNUM
TVSTRL
TVENRL
1
EX1
TV
1
Start of Screen Epoch
1 hour after start of Visit
2
EX1
TV
2
30 minutes before end of Screen Epoch
30 minutes after start of Run-in Epoch
3
EX1
TV
3
30 minutes before end of Run-in Epoch
1 hour after start of Product Exposure Epoch
4
EX1
TV
4
1 week after start of Product Exposre Epoch
1 hour after start of Visit
5
EX1
TV
5
2 weeks after start of Product Exposre Epoch
1 hour after start of Visit
6
EX1
TV
6
After last Product Exposure Epoch
1 hour after start of Visit
$warningHtml
tv.xpt
tv.xpt
Row
STUDYID
DOMAIN
VISITNUM
TVSTRL
TVENRL
1
EX1
TV
1
Start of Screen Epoch
2
EX1
TV
2
On the same day as, but before, the end of the Screen Epoch
On the same day as, but after, the start of the Run-in Epoch
3
EX1
TV
3
On the same day as, but before, the end of the Run-in Epoch
On the same day as, but after, the start of the Study Product Exposure Epoch
4
EX1
TV
4
1 week after start of Product Exposure Epoch
5
EX1
TV
5
2 weeks after start of Product Exposure Epoch
6
EX1
TV
6
After last Product Exposure Epoch
At Trial Exit
$warningHtml
Although the start and end rules in this example reference the starts and ends of epochs, the start and end rules of some visits for trials with epochs that span multiple elements will need to reference elements rather than epochs. When an arm includes repetitions of the same element, it may be necessary to use TAETORD as well as an element name to specify when a visit is to occur.