Managing Participants in Study Connect

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

Note Veeva ePRO is only available to sites conducting a study whose sponsor is utilizing Veeva ePRO in a Clinical Vault.

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 ePRO 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 required in order for the participant to register an account in MyVeeva for Patients where they receive and submit surveys.
4. Select Create.

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 ePRO 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 ePRO 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, 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 ePRO 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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