Similar to Fixed Visits and Events, Unscheduled or Variable Visits allow Study Designers to define rules for easier completion of data entry forms by Site Staff / Data Coordinators (or someone in a similar role).
Overview of Unscheduled Visits
When events occur, they are not always scheduled. Adverse Events, for example, oftentimes lead to unscheduled follow-up visits. An unscheduled follow-up visit might require that several forms be completed, such as labs, physical exams, and vitals.
For these types of events, TrialKit allows the Study Designer to create Variable Visits/Events tables. To set up a variable visit, select the Create or Edit Unscheduled Subject Visits or Events menu option in the Study Menu.
Setting Up a Variable Event Table
Prerequisite:
Access to Subject Record Page Design
Access Unscheduled visit configuration under the study menu.
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Modify existing visits or add new ones with the options described below.
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Table Style
This is how the visit forms will be displayed within the subject's case book.
The option to display all forms will visually display all possible forms across the page. This is the preferred method if only a few possible forms will be collected.
If several possible forms exist, displaying them all will cause the page to stretch horizontally. In this case, it is best to choose the Select Form option.
Sequence
The sequence determines the order of event tables when rendered on the Subject Record Page.
Cyclical
If selected (Yes), the event will be cyclical. That means you have multiple event cycles which render to multiple tables within a single event. This is like another layer within each event.
As an example, in the context of something like an Oncology trial, Cyclical treatments can occur based on a variable type of event. Cancer treatment cycles require that one or more treatments occur within a single cycle. However, when some event occurs, the subject may start on another treatment cycle. A single treatment will almost always require that multiple forms be completed. With treatment cycles, multiple forms must be completed for multiple treatments in multiple cycles.
Fixed Date
Similar to Interval Date Entry you can use the Event Date, which is entered when creating a new event row by the coordinator, to automatically populate the visit date of all event forms.
Included Forms
Variable events must have at least one form to complete per event. Most should have two or more. Because Log Forms allow for just a single form to be completed per event, they should be used in lieu of variable events if only a single form is required. For example, Medications should be in a log form and not a variable event. Variable events should be created when two or more forms are required per event.
Users will enter these unscheduled visits within the subject casebooks, where each event/date entered gets a new sequential visit ID (Vee_id) which is displayed in the data exports.
