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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.

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.

Excerpt Include
Example Trial Study 1, Parallel Design Planned Visits
Example Trial Study 1, Parallel Design Planned Visits

Include Page
Example Trial Study 1, Parallel Design Planned Visits
Example Trial Study 1, Parallel Design Planned Visits

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. TVSTRL shows the rule that defines the start of the visit, and TVENRL shows the rule that defines the end of the visit

Dataset wrap
Nametv
Dataset2
RowSTUDYIDDOMAINVISITNUMVISITTVSTRLTVENRL
1EX1TV1SCREENINGStart of Screen Epoch1 hour after start of Visit
2EX1TV2BASELINE30 minutes before end of Screen Epoch30 minutes after start of Run-in Epoch
3EX1TV3WEEK 230 minutes before end of Run-in Epoch1 hour after start of
Study
Product Exposure Epoch
4EX1TV4WEEK 41 week after start of
Study
Product
Exposre
Exposure Epoch1 hour after start of Visit
5EX1TV5WEEK 62 weeks after start of
Study
Product
Exposre
Exposure Epoch1 hour after start of Visit
6EX1TV6FOLLOW-UPAfter last
Study
Product Exposure Epoch1 hour after start of Visit
Dataset wrap
Nametv
Dataset2
RowSTUDYIDDOMAINVISITNUMVISITTVSTRLTVENRL
1EX1TV1SCREENINGStart of Screen Epoch
2EX1TV2BASELINEOn the same day as, but before, the end of the Screen EpochOn the same day as, but after, the start of the Run-in Epoch
3EX1TV3WEEK 2On the same day as, but before, the end of the Run-in EpochOn the same day as, but after, the start of the Study Product Exposure Epoch
4EX1TV4WEEK 41 week after start of Study Product Exposure Epoch
5EX1TV5WEEK 62 weeks after start of Study Product Exposure Epoch
6EX1TV6

FOLLOW-UP

After last Study Product Exposure Epoch

At Trial Exit

...