This TV trial design domain, based on the Trial Design Model, contains the planned order and number of visits in the study within each arm. Visits are defined as "clinical encounters" and are described using the timing variables VISIT, VISITNUM, and VISITDY. Protocols define visits in order to describe assessments and procedures that are to be performed at the visits.
Example
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.
Example 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
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.
Overview
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