Managing Participants in Study Connect

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

Creating Participants in Study Connect

You can create a participant in Study Connect to send them eConsent forms to sign electronically.

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

1. In Study Connect, select eConsent 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.
     • If you enter an email and phone number, they can register in MyVeeva for Patients using that information and sign eConsent forms on their own device.
     • If you don’t enter an email and phone number and they don’t wish to register in MyVeeva for Patients, they can only sign eConsent forms in-person at your site on your site’s device.
     • If you don’t enter an email and phone number and they wish to register in MyVeeva for Patients, they must register with a Device Registration Code (DRC) that you create for them (available for iOS and Android).
4. Select Create.

Creating a Device Registration Code for PIN Access

Generate a Device Registration Code 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 eConsent on the left menu.
2. On the Participants tab, locate and select the participant beneath the Patient Name column. The participant’s page opens.
3. On the participant’s page, select the Generate Device Registration Code icon.
4. Allow the participant to scan the QR code or provide the participant with the generated code. If needed, the DRC can be printed to allow the participant to complete the process at a later time.

Creating Representatives for Participants

You can create representatives (such as guardians, proxies, translators, or witnesses) for participants in Study Connect.

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

1. In Study Connect, select eConsent on the left menu.
2. On the Participants tab, locate the participant beneath the Patient Name column and select the Create Signatory icon ().
3. In the Create a Participant Representative pop-up, enter the signatory’s personal and contact information and select their role:
   • Personal Information: Their first name and last name are required. Their middle name and language are optional.
   • Contact Information: Their email and phone number are optional. If you enter an email and phone number for them, they can create a MyVeeva for Patients account to sign eConsent forms on their own device. If you don’t enter an email and phone number for them, they can only sign eConsent forms in person at your site on your site’s device.
   • Participant Representative Role: Their participant representative role is required.
4. Select Create.

Viewing Participants

You can view and manage study participants in Study Connect.

To view and manage a participant in Study Connect, complete the following steps:

1. In Study Connect, select eConsent on the left menu.
2. On the Participants tab, all participants are displayed. This page displays an overview of information about participants including their study participant ID, email, and phone number.
3. To view and manage an individual participant in more detail, select their name beneath the Patient Name column. The participant’s page opens. This page displays detailed information about the participant, including their representatives and signatories, all consent forms they’ve signed, and their eConsent form responses.
   • If the participant is enabled with ePRO, you can also view their participant events by expanding the Participant Events section.

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.

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 eConsent on the left menu.
2. On the Participants tab, select the participant beneath the Patient Name column. The participant’s page opens.
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.

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 eConsent on the left menu.
2. On the Participants tab, select the participant beneath the Patient Name column. The participant’s page opens.
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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