Site users access eCOA using VeevaID. Site users are created and assigned in a single step when they are added to a study using their email. You should not create site users as Vault users the same way you would for internal users.

Creating and Assigning a Site User

Complete the following steps to create and assign a site user so they can use eCOA:

  1. In the Site Personnel section on Study, Study Country, or Study Site, select Create. Populate or confirm the following information:
    • Study
    • Study Country
    • Study Site
    • User’s Email
    • User’s Site Role
      • See Site Roles section for more information.
    • Restricted Data Access: This checkbox is only displayed if the study contains restricted data. Select this if you want to allow the user to be able to view restricted data.
  2. Select Save.

Once added to the study, the user is invited via email to register for VeevaID or log in to their existing VeevaID account. If the user does not already have a VeevaID account, their name is listed as Awaiting Registration until they register for VeevaID.

Looking for internal user assignment information? See Managing Internal Users.

Site Roles

The following site roles are available for site users.

  • Coordinator
    • Can view all data and perform all actions in Veeva eCOA
  • Investigator
    • Can view all data and perform all actions in Veeva eCOA
  • Site Viewer
    • Can view all data and download reports in Veeva eCOA

Restricted Data Access

The Restricted Data Access setting controls whether the site user can see restricted data. This setting applies to viewing surveys in Veeva eCOA and any exports generated by the user.

Update Site User Access

Once a site user record is created, you cannot edit any fields, including Role and Restricted Data Access. To change the user’s access, you must complete the following steps:

  1. Find the user in the Site Personnel section on Study, Study Country, or Study Site, and select Inactivate.
  2. Create a new site user record with the changes you want to make.

You cannot reactivate a site user record that is Inactive. To grant access to the site user again, create a new site user record.

Resend VeevaID Registration

When a site user has a status of Awaiting Registration, you can resend the VeevaID registration email by selecting Resend VeevaID Registration from the actions menu All Actions button of the site personnel record. You can use this functionality if the site staff did not receive the email or it might have been sent to their spam folder.

Inactivate a Site User

To remove a site user’s access to the study site in Veeva eCOA, select Change State to Inactive from the actions menu All Actions button of the site personnel record.