Unscheduled Events can be enabled for a study if you will need to enter data that is not a part of the regular data events. Unscheduled Events can be registered as many times as needed and at any timepoint throughout the study. Typical examples of forms that are filled out during Unscheduled Events are Protocol Deviations and Device Deficiencies.
Enable Unscheduled Events
- Create your forms that will be used for unscheduled events
- Go to Processes from the main building page or the left-side menu
- Click New Process or edit a current process
- Enable the Unscheduled Events button
- Select the forms that will be used for the Unscheduled Events in the fields "Mandatory forms for unscheduled events" and/or "Optional forms for unscheduled events"
Mandatory forms have to be filled out every time an Unscheduled Event occurs, while optional forms let you choose which of the forms to complete. - Click Save Process when you are done setting up your process
Reporting an Unscheduled Event
- The study has to be in either test or data collection mode in order to report an unscheduled event
- Go to the site of interest
- Find the relevant subject and click on the unscheduled event icon
below actions
- A menu will show up with a marking on the mandatory forms and with the option of selecting between your optional forms.
The permission "Unscheduled" is required for reporting an unscheduled event.
For a more detailed description of how to register unscheduled events, see the Register Unscheduled Events help article.
Help Video
The video below demonstrates how to enable unscheduled events and explains the difference between mandatory and optional forms for unscheduled events.