Similar to Fixed Visits and Events, Unscheduled or Variable Visits allows Study Designers to define rules for completing data entry forms that are easy for your Data Coordinators (or someone in a similar role) to follow. When events occur, they are not always scheduled. Adverse Events oftentimes lead to unscheduled follow up visits. An unscheduled follow up visit might require that several forms be completed.
Cyclical treatments oftentimes occur based on a variable type event. Cancer treatment cycles require that one or more treatments occur within a single cycle. Then 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 for multiple cycles.
For these types of events, Clinical Studio allows the Study Designer to create Variable Visits/Events tables. To setup 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
The figure below shows the Variable Visits/Events page.
Add New Event Form
The following describes each field in the Add New Event form.
The Event Name is displayed above the event tables and labels the actual table. For cyclical events, it labels the Cycle field.
The sequence determines the order of event tables when rendered in the Subject Record Page.
If selected (Yes), the event will be cyclical. That means you have multiple event cycles which render to multiple tables within a single event.
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 as shown in the figure below.
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 a log form and not a variable event. Variable events should be created when two or more forms are required per event.