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 Study 1, Parallel Design Planned Visits |
|---|
| Example 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 |
|---|
|
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | VISITNUM | VISIT | TVSTRL | TVENRL |
|---|
| 1 | EX1 | TV | 1 | SCREENING | Start of Screen Epoch | 1 hour after start of Visit | | 2 | EX1 | TV | 2 | BASELINE | 30 minutes before end of Screen Epoch | 30 minutes after start of Run-in Epoch | | 3 | EX1 | TV | 3 | WEEK 2 | 30 minutes before end of Run-in Epoch | 1 hour after start of |
Treatment | Product Exposure Epoch | | 4 | EX1 | TV | 4 | WEEK 4 | 1 week after start of |
Study Administration | Exposure Epoch | 1 hour after start of Visit | | 5 | EX1 | TV | 5 | WEEK 6 | 2 weeks after start of |
Study Administration | Exposure Epoch | 1 hour after start of Visit | | 6 | EX1 | TV | 6 | FOLLOW-UP | After last |
Study Administration | Exposure Epoch | 1 hour after start of Visit |
|
|
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | VISITNUM | VISIT | TVSTRL | TVENRL |
|---|
| 1 | EX1 | TV | 1 | SCREENING | Start of Screen Epoch |
| | 2 | EX1 | TV | 2 | BASELINE | 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 | WEEK 2 | 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 the Study Product Administration Exposure Epoch | | 4 | EX1 | TV | 4 | WEEK 4 | 1 week after start of Study Product Administration Exposure Epoch |
| | 5 | EX1 | TV | 5 | WEEK 6 | 2 weeks after start of Study Product Administration Exposure Epoch |
| | 6 | EX1 | TV | 6 | FOLLOW-UP | After last Study Product Administration Epoch Exposure Epoch | At Trial Exit |
|
|
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.