Overview

You can enable ePRO for participants in Study Connect to allow them to receive surveys and notifications in MyVeeva for Patients on their own device or on a provided device.

Prerequisites

In order to enable a participant with ePRO, the following prerequisites must be met:

• Study Invitation: Your study’s sponsor must be using Veeva ePRO and your site administrator must have accepted the sponsor’s study invitation. See the Connecting Your Study to ePRO help topic for more information.
• Participant: A participant record must be created. See the Managing Study Participants in Study Connect help topic for more information on creating or updating participant records.

Enabling ePRO for a Participant

Enabling ePRO for a participant means they can be assigned the study’s ePRO schedules, receive survey tasks, and be notified of their available, due, and missed surveys. When you enable a participant with ePRO in Study Connect, they take their surveys in the MyVeeva for Patients application. See the Surveys help topic in MyVeeva for Patients Help for more information.

Each participant must be enabled with ePRO to participate in a Veeva ePRO study. Surveys or survey-related notifications may not appear for the participant until you enter the dates and times for their participant events. See the Managing Participant Event Dates and Times help topic for more information.

1. In Study Connect, select Surveys on the left menu.
2. Select the Participants tab.
3. On the Participants page, select the participant beneath the Patient Name column.
4. Locate the ePRO Status field and select Enable, which opens a new window for the enablement process.
5. If applicable for your study, determine the appropriate participant group(s), then click Next.
6. If applicable for this participant, select or create a Caregiver, then click Next. Only one at a time is permitted, but the selection can be edited, as needed.
   • Note: Caregivers created during this process are created in the SiteVault Administration tab.
7. On the Confirmation page, review the information listed for accuracy.
   • If an edit is required, select Back and adjust as needed.
   • If accurate, select Enable.
8. On the What’s Next? page, review for next steps to be completed.
9. Select Close to complete the setup process.

Once enabled, participants and their caregiver, if applicable, receive a welcome email with instructions for registering a MyVeeva for Patients account. Participants and/or caregivers must register or already have a registered account in the MyVeeva for Patients application to begin taking surveys. If they need help registering a MyVeeva for Patients account or managing their surveys in MyVeeva, see the Registration and Login and Surveys help topics in MyVeeva for Patients Help.

After a participant is enabled with ePRO, all relevant participant events for the study or the participant’s groups, if applicable, are automatically created for them under the participant events section on the participant’s page in Study Connect. Any schedules or notifications related to the assigned events begin or send as soon as a participant is enabled with ePRO.

Managing ePRO

It may be necessary to update a participant’s group if the previously selected group no longer applies. It may also be necessary to change a participant’s assigned caregiver. Use the steps below to complete participant group or caregiver changes.

1. In Study Connect, select Surveys on the left menu.
2. Select the Participants tab.
3. On the Participants page, select the participant beneath the Patient Name column.
4. Locate the ePRO Status field and select Manage, which opens a new window.
5. If needed, adjust the selected participant group(s), then click Next.
6. If needed, select or create a new Caregiver. Only one at a time is permitted, but the selection can be edited, as needed.
   • Note: Caregivers created during this process are created in the SiteVault SiteVault Administration tab.
7. On the Confirmation page, review the information listed for accuracy.
   • If an edit is required, select Back and adjust as needed.
   • If accurate, complete the Reason for Change field and select Enable.
8. On the What’s Next? page, review for next steps to be completed.
9. Select Close to complete the process.

Disabling ePRO for a Participant

Disabling ePRO for a participant means they’re no longer assigned your study’s survey schedules and no longer receive surveys and notifications.

1. In Study Connect, select Surveys on the left menu.
2. Select the Participants tab.
3. On the Participants page, select the participant beneath the Patient Name column.
4. On the participant’s page, select Disable ePRO from the all actions menu (). There may be a delay of a few minutes while ePRO is disabled for the participant, and you receive a notification when it’s complete.