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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.

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No link could be created for 'Example Trial 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.

tv.xpt

tv.xpt

RowSTUDYIDDOMAINVISITNUMTVSTRLTVENRL
1EX1TV1Start of Screen Epoch1 hour after start of Visit
2EX1TV230 minutes before end of Screen Epoch30 minutes after start of Run-in Epoch
3EX1TV330 minutes before end of Run-in Epoch1 hour after start of Treatment Epoch
4EX1TV41 week after start of Study Product Administration Epoch1 hour after start of Visit
5EX1TV52 weeks after start of Study Product Administration Epoch1 hour after start of Visit
6EX1TV6After last Study Product Administration Epoch1 hour after start of Visit
$warningHtml

tv.xpt

tv.xpt

RowSTUDYIDDOMAINVISITNUMTVSTRLTVENRL
1EX1TV1Start of Screen Epoch
2EX1TV2On 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
3EX1TV3On 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 Administration Epoch
4EX1TV41 week after start of Study Product Administration Epoch
5EX1TV52 weeks after start of Study Product Administration Epoch
6EX1TV6

After last Study Product Administration Epoch 

At Trial Exit

Dataset Debug Message

There are two leading, trailing, or non-breaking spaces in the dataset.

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.

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