To build and activate OpenClinica Participate for your Study:
- Once the Study is created, select Tasks > Build Study.
- Complete the Build Study tasks as described in Build and Modify Study, with the following differences:
- When creating CRFs, be sure to reference the popup help and Instructions worksheet of the OpenClinica CRF Template for information regarding Participate forms. Information specific to Participate functionality is also summarized in the section of documentation called OpenClinica Participate Forms.
- When creating the Event Definitions, for any form that you would like a participant to complete, just check the Participate Form box. You may have a mix of forms for any given Event, where some forms are to be completed by the patient, and others are to be completed by Site personnel.
- In the Modules section of the Build Study window, note that the Status for the Participate Module is set to Disabled.
- To request access to OpenClinica Participate for the Study, in the Modules section, click .
The following window displays: - Enter your preferred subdomain for the Participate Study.
A subdomain is part of a web address (URL) and required to create a web address for your Study. OpenClinica provides the secure access (https://) and .mystudy.me domain portions of the URL, but you must provide a unique subdomain name for accessing this particular Study. For example, for the JUNO diabetes study, we entered the subdomain JUNO, for a complete web address of https://JUNO.mystudy.me.
- Once you have provided a unique subdomain, click Request Access.
The Build Study page displays, and the status for Participate is set to Pending.
A request is sent to OpenClinica. For your TEST environment, access will be granted unconditionally. For your PRODUCTION environment, access will be granted once the OpenClinica Participate contract information has been verified.Once approved, the status of the Participate module changes to Active as follows:
The Study is activated for OpenClinica Participate. To deactivate Participate for the Study, click in the Participate Actions column. - To provide access to participants, each participant must be enrolled and have at least one Event scheduled that includes at least one Participate form. For more information on these tasks, see Add Subject and Connect Participants.