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 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.
4. Select Create.

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.

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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Overview of Veeva eConsent

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