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Example Trial 1, Parallel Design Planned Visits | Example Trial 1, Parallel Design Planned VisitsTwo 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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| Example Trial 1, Parallel Design Planned Visits |
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| Example Trial 1, Parallel Design Planned Visits |
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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.
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| Dataset2 |
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| Row | STUDYID | DOMAIN | VISITNUM | TVSTRL | TVENRL |
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| 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 Treatment Epoch | | 4 | EX1 | TV | 4 | 1 week after start of Study Product Administration Epoch | 1 hour after start of Visit | | 5 | EX1 | TV | 5 | 2 weeks after start of Study Product Administration Epoch | 1 hour after start of Visit | | 6 | EX1 | TV | 6 |
3 weeks after start of | After last Study Product Administration Epoch | 1 hour after start of Visit |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | VISITNUM | TVSTRL | TVENRL |
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| 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 Treatment the Study Product Administration Epoch | | 4 | EX1 | TV | 4 | 1 week after start of Study Product Administration Epoch |
| | 5 | EX1 | TV | 5 | 2 weeks after start of Study Product Administration Epoch |
| | 6 | EX1 | TV | 6 | 3 weeks after start of After last Study Product Administration Epoch | At Trial Exit |
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