Managing Participants in Study Connect

In Study Connect, a participant is a patient who is being screened for or participating in a clinical study.

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Note Veeva ePRO is only available to sites whose sponsors are using Veeva ePRO in Clinical Operations.

Overview

• You can manage most participant activities on the Surveys > Participants tab, by using the icons and menu in the top right and the Participant Events list.
• The Participant Events widget provides access to:
  • Event information
  • Event action indicator
    • Orange indicator: Site staff actions available
    • Grey indicator: No immediate staff actions available
    • Green indicator: All actions completed
  • Actual Datetime field
  • View completed participant surveys (ePRO)
  • View and complete site surveys (eClinRO)
  • Survey scoring (available while viewing completed ePRO and eClinRO surveys)

Viewing Completed Surveys

You can view completed surveys and their scores (if configured) from Participant Events.

To view a completed survey, complete the following steps:

1. In Study Connect, select Surveys on the left menu.
2. On the Participants tab, select the participant beneath the Patient Name column.
3. Select an event from the Participant Events widget.
4. Select a completed survey to review.
5. Select Close when finished.

Viewing Participant Survey Compliance

• Participant survey compliance warnings are available on the Surveys > Overview tab.
• The Survey Compliance Warnings widget displays:
  • Upcoming surveys
  • Surveys missed in the last 7 days
• Compliance warnings for upcoming surveys are only available when configured by the sponsor.
• Participant contact information is available by clicking the Contact icon to the right of the Participant name.
• Use the Edit icon in the Notes column to document information to share with site staff.

Creating Participants

You can create a participant in Study Connect to enable them with ePRO.

To create a participant in Study Connect, complete the following steps:

1. In Study Connect, select Surveys on the left menu.
2. On the Participants tab, select Create Participant.
3. In the Create a Study Participant pop-up, enter the participant’s personal and contact information.
   • Personal Information: Their first name, last name, language, date of birth, and study participant ID are required. Their middle name is optional.
   • Contact Information: Their email and phone number are optional. Participants with a valid email and phone number can register in MyVeeva for Patients using that information. Participants without a valid email and/or phone number must register in MyVeeva for Patients with a Device Registration Code that you create for them.
4. Select Create.

Creating a Device Registration Code for PIN Access

You can generate a Device Registration Code (DRC) for a participant who can’t register for MyVeeva using an email address and phone number. Participants can enter the DRC to enable PIN access and set their own PIN. Note that participants must be using the MyVeeva for Patients mobile app to enable PIN access.

To create a DRC for a participant, complete the following steps:

1. In Study Connect, select Surveys on the left menu.
2. On the Participants tab, locate and select the participant beneath the Patient Name column.
3. On the participant’s page, select the Generate Device Registration Code icon.
4. Provide the participant with the generated code. If the participant doesn’t already have the MyVeeva for Patients mobile app, they can scan the QR code with their mobile device to open the app store. If needed, the page can be printed to allow the participant to complete the process at a later time.

Initiating a Participant In-Person Survey

Site users can use a site device or a separate device (example: participant’s phone) to give participants access to their surveys while at the site. Sponsors can indicate whether a survey should be conducted at home or at a site.

To initiate In-Person surveys, complete the following steps:

1. In Study Connect, select Surveys on the left menu.
2. On the Participants tab, select the participant beneath the Patient Name column.
3. Expand the Participant Events section and locate the event.
4. Enter the Actual Datetime, if none exists.
5. Select the event.
6. Select the Start Surveys In-Person button on the right side of the Participant Survey widget.
7. Select one of the following device options:
   • Use this device: The participant completes the survey(s) on the site device. To select, click Start.
   • Use Another Device: The participant completes the survey(s) on a different device. To select, scan the QR code with the different device.
8. The participant confirms their identity.
9. The participant completes and submits any available surveys.
10. The participant selects End Session.
    • If using the site device, the participant returns the device to a site user.

Editing Participants

You can edit participants in Study Connect if you need to update their personal or contact information.

To edit a participant in Study Connect, complete the following steps:

1. In Study Connect, select Surveys on the left menu.
2. On the Participants tab, select the participant beneath the Patient Name column.
3. On the participant’s page, select the Edit Participant icon ().
4. In the Edit a Study Participant pop-up, edit the participant’s personal or contact information.
5. Select Update.

Creating Visits for Study Participants

Using your preferred digital calendar platform (such as Gmail, Outlook, or Teams), you can create in-person or virtual study visits for a study participant to view details about and join in the MyVeeva for Patients app. You can create an in-person visit with instructions in the body of the invitation, or you can create a virtual visit containing a virtual meeting join link. Visits you create are organized in a visit list view for a participant to view and join from the Visits page in the MyVeeva for Patients app. You must have invited a participant to use MyVeeva for Patients in order to schedule visits for them in SiteVault. Sending them an eConsent form, enabling them with ePRO, or sharing a study document with them in SiteVault invites them to use MyVeeva for Patients.

Creating a Visit

To create an in-person or virtual study visit for a participant, complete the following steps:

1. On the Participants tab, select the participant beneath the Patient Name column.
2. Locate the participant’s MyVeeva calendar alias and select the copy icon to copy it to your clipboard.
3. In your preferred digital calendar platform, create a calendar appointment and enter the participant’s MyVeeva calendar alias as an invitee.
   • Enter the correct date, time, and description for the visit as these details appear on the participant’s visit list in MyVeeva for Patients exactly as you enter them. Rich text formatting such as bold, italics, and underlines are supported. Ordered or bulleted lists, tables, indents, and attachments aren’t supported.
   • If a visit is a virtual visit (such as through Meet, Skype, Teams, or Zoom), enter the virtual meeting join details in the description. The participant can join the virtual meeting in the MyVeeva for Patients app at the appropriate time.
   • You can invite multiple study participants to the same visit by entering all applicable MyVeeva calendar aliases as invitees.
4. Send the appointment invitation. The appointment is added to the participant’s visit list in MyVeeva for Patients. We notify the participant when you create a visit and when the visit is approaching. We also notify you when the meeting is processed and added to the participant’s visit list in MyVeeva for Patients or when the invitation fails to process.

Note You can only create a visit using an email address that’s linked to a SiteVault user account.

Updating or Canceling a Visit

You can update an existing visit’s details (such as the date, time, and description) or cancel a visit in your digital calendar platform. The changes you make to the visit apply to the participant’s visit list in MyVeeva for Patients. Canceling a visit removes it from the participant’s visit list. We notify the participant when you update or cancel a visit. We also notify you when the update or cancellation is successful or when it fails to process.

Note You can’t update or cancel a visit from your digital calendar platform if its meeting time is in the past. If you need to update a past visit, delete it from your digital calendar platform and create a new visit.

Withdrawing Participants

If a participant wants to withdraw from a study, they’ll need to contact the site staff and request it. You can then remove the participant from the study in Study Connect.

To withdraw a participant, complete the following steps:

1. In Study Connect, select Surveys on the left menu.
2. On the Participants tab, select the participant beneath the Patient Name column.
3. On the participant’s page, expand the Participant Events section and locate the Study Withdrawal event.
4. Select the field beneath the Actual Datetime column and select a date and time.
5. Select Save.

Removing Participants Created in Error

If a participant was created in error, you can remove the participant from the study in Study Connect.

To remove a participant, complete the following steps:

1. In Study Connect, select Surveys on the left menu.
2. On the Participants tab, select the participant beneath the Patient Name column.
3. On the participant’s page, select the all actions menu () and select Remove from Study.
4. On the confirmation pop-up, select Yes.

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