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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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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 treatment epoch (the first dose of study drug) occurs during visit 3.
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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 Treatment Epoch | 1 hour after start of Visit | 5 | EX1 | TV | 5 | 2 weeks after start of Treatment 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 Epoch | 4 | EX1 | TV | 4 | 1 week after start of Treatment Epoch |
| 5 | EX1 | TV | 5 | 2 weeks after start of Treatment Epoch | At Trial Exit | |
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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.