Once OC4 Participate access has been activated (see Activate OC4 Participate), Data Managers can designate forms within Visit-Based events as Participate forms. Participate forms are not yet available for use in Common events.

For any form that you would like a Participant to complete, select the Participate Form checkbox in the form properties:

The Participant Form checkbox becomes available as soon as access to the Participate module is requested (while it’s in Pending status). The functionality is not fully available until Participate has been activated by OpenClinica (Active status).  

Once the Participate status is set to Active and the Participant Form property is checked, the form properties and version menu display and function as follows:

  • The SDV selection is set to Not Applicable by default, but can be set to any of the other SDV options as desired.
    • If you clear the Participate Form checkbox, the SDV selection is reset to Not Required, and can be set to any of the other options as desired.
  • The Preview button changes to Preview (As a Participant). This displays the form as a Participant would see it – without the option to use query bubbles, and with all constraints and required fields acting as “hard” checks.
    • Hard checks require that the value meets the constraint criteria in order to advance to the next page or to close/submit the form.
  • The form version menu allows you to Preview – this is the non-participant preview, which includes query bubbles, or to Preview (As a Participant) as described above. Though Data Managers, Monitors, and CRCs would not be querying the Participant, they can use the query bubbles on Participate Forms to communicate with each other. Participants do not have access to view any queries or query history.

If you include a Participate Form in a Visit-based event and later change that event to a Common event:

  • The system removes the Participate Form selection; Common events do not support Participate Forms at this time.
  • The system sets the SDV setting to “Not Required.”

 

Tracking Changes to Participate Settings

All manual and systematic changes to Participate Form and SDV settings related to Participate Forms are recorded in the Form history and Design page audit panel.

Form History: Design Audit Panel:

 

Participate Forms and Permission Tags

Permission tags do not apply to Participants. If a form is designated as a Participate Form, Participants will be able to see that form regardless of the Permission Tag attached to that form.

If a Participate Form has a Permission Tag attached to it, only OpenClinica user roles that have been granted access to that Permission Tag will be able to acces that form. For more information on Permission Tags and User Roles, see Add Tags and Define Configurable User Roles.

 

Using Participate Forms

Once Participate is active and Participant forms have been published, the Participant form is available for use. See Invite Participants and The Participant’s View for more information on using the Participate forms in your study.