If OC4 Participate has been activated for your study and Participate Forms have been designed, those forms are available for Participants to complete. Each Participant must be invited to Participate prior to completing those forms. CRCs and Investigators, and any customized roles that are based on the CRC or Investigator roles, have access to invite Participants.
Add a Participant to a Participate Study
Once the Participant has been added to the study, the Participant Details page displays. For site users with appropriate access, the Participant Details page includes links to Invite a Participant or to View the participant access code:
Invite a Participant
To invite a Participant to complete Participate Forms:
- In the General Information section of the Participant Details Page, click Invite.
The following displays:
- To create a Participant account for use on a device used in-clinic, all fields are optional; you can click update to create the account and the Participant access code.
To create a Participant account for the Participant to use his/her own personal device, enter the Participant’s first name and email address.
Currently email is the only means of communicating with Participants (sending notifications, sending access information, etc.) Provide an SMS Mobile phone number if desired. This functionality will be available in the future. If you enter the information now, you will be ready for that functionality once it is activated.
- For the Invite via email question:
> To send the invitation immediately, select Yes and click Update.
> To send the invitation at a later time, select No and click Update. (If you select No, to send the invitation at a later time, return to the Participant Detail page when you are ready to send the invitation, click Invite, and select Yes.)To ensure privacy and security, all Participant Personal Identifying Information (PII) is encrypted in the database. The unencrypted information is only visible to CRC-based roles and Investigator-based roles, and only on the Participant Details page.
Once the information has been updated, you return to the Participant Details page and the Participant’s contact information is displayed.
The Participant Status is displayed as part of the Participant details, and is defined as follows:
The Participant Status is also visible in the Participant Matrix. To view the Participant Status, click Show More, above the matrix:
- Schedule Events as appropriate for the Participant.
Forms that have been identified as Participate Forms can be completed by Active Participants. When the Participant enters data into a Participate form, that form data is immediately available for review.
Forms that are not identified as Participate Forms are available for CRCs or Investigators to enter.
Note:
When you invite a Participant to a study, you are actually creating a user with a user type of “Participant”. Though they are defined as “users”, they are not listed on any of the user listings or extracts. Specifically:
- If you access Tasks–>View Study, users who are designated as Participants are not listed in the User table.
- If you download the study metadata, Participant users are not included in the XML
- If you download a casebook in XML or JSON format, Participant user types are not included in the results
- Participant users are not available in the user search boxes (e.g., assigning a query)
- Participant users are not listed on the Share Study page (available to Data Managers and Administrators)
- Participant users are not displayed in the Central User Administration page (which is available to Administrators only)
- The Audit Log does not contain any Participant identifiable information
- Extracts do not include Participant identifiable information. In addition, the XML extracts do not include Participant user types.
View Participant Access Code
For studies that have been designed to collect Participant data in-clinic rather than on individual Participant devices, CRCs and Investigators may need to view the Participant Access Code in order to allow the participant to enter data on a clinic device.
CRCs and Investigators have access to view Participant Access codes as long as the Participant has a status of Created, Invited, or Active.
Note:
Viewing the Participant Access Code should only be done if it is defined as a permitted action in the Study Protocol. Once the access code has been viewed, there is no way to distinguish in the audit log whether the data was actually entered by the Participant or by the CRC or Investigator who viewed the access code.
Though the action of viewing the code is tracked in the audit log, once that code has been viewed, anyone with that code could enter data as the Participant.
If you have any questions regarding whether you should view the access code or not, please check with your Study Monitor or Data Manager prior to viewing the code.
Once you have taken the above note into full account, to view the access code:
- In General Information section of the Participant Detail page, click View participant access code.
The following displays:
The Access Code is masked so you have the opportunity to close the page without viewing the code in the event that you accessed this page inadvertently. - If you are certain that viewing the code is permitted in your study, to view the code, click the eye icon.
The access code is revealed. Use the Participate URL and the access code to access Participant forms.
The Audit Log includes entries indicating that the Access Code was viewed, when it was viewed, and the username of who viewed it:
Remove a Participant from a Participate Study
If you remove a Participant from a Participate study:
- The Participate status in the Participant Matrix is set to Inactive
- The Participant status is set to removed and the contact information and links are removed from the Participant Details page
- The Participant’s access code is deactivated; an authentication error displays if the Participant tries to access Participate
- If the Participant is restored the statuses, access, and Participant details are restored to their previous settings
