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:
- In Study Connect, select ePRO on the left menu.
- On the Participants tab, select Create Participant.
- 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.
- 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:
- In Study Connect, select ePRO on the left menu.
- On the Participants tab, select the participant beneath the Patient Name column. The participant’s page opens.
- On the participant’s page, select the Edit Participant icon (
).
- In the Edit a Study Participant pop-up, edit the participant’s personal or contact information.
- 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:
- In Study Connect, select ePRO on the left menu.
- On the Participants tab, select the participant beneath the Patient Name column. The participant’s page opens.
- On the participant’s page, expand the Participant Events section and locate the Study Withdrawal event.
- Select the field beneath the Actual Datetime column and select a date and time.
- 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:
- In Study Connect, select ePRO on the left menu.
- On the Participants tab, select the participant beneath the Patient Name column. The participant’s page opens.
- On the participant’s page, select the all actions menu (
) and select Remove from Study.
- On the confirmation pop-up, select Yes.