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, for example, often times lead to unscheduled follow up visits. An unscheduled follow up visit might require that several forms be completed, such as labs, physical exam, and vitals.
Additionally, there is can be one more layer within an unscheduled visit. In the context of something like an Oncology trial, Cyclical treatments can 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.
From here you can create an option for the site users to enter unscheduled visits and collect data at that level.
Setting Up a Variable Event Table
This is how the visit's forms will be be displayed within the subjects 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 exists, displaying them all will cause the page to stretch horizontally. In this case, its best to choose the Select Form option.
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.
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.