The User & Roles page displays the names, emails, roles, and sites for everyone with access to your study. From this page, it is possible to revoke access, view pending study invitations, and re-send or cancel invitations.

Name: Displays the name of the user once they have accepted the invitation. Rejected status means that the user has declined the invitation. Invite sent - invitation has been sent and awaiting confirmation from the study team member.

Email: Email of the user.

Roles: Displays the roles assigned to the user.

Sites: Shows the sites to which the user has access.

Options: Allows the study admin to manage users.

Role(s)

The user role(s) can be assigned at the Study level, which means that the role will be applicable for all sites in the study. This includes the role(s) of Study Admin, Study Monitor, Study Investigator, and Study Read-only. Alternatively, you can assign site-specific user roles which will only be linked to selected site(s). These include the role(s) of Site Admin, Site Investigator, and Site Monitor. 

It is possible to choose from the following list of the default roles:

Study admin: The study admin can perform all actions related to the study settings, Org & Site, User Roles, and Consent forms

 Site admin: The site admin can view study settings, organization and sites, view, add and edit user & roles, consent forms, invite, view non PII and PII, edit and sign ICF, and view the audit trail.

Study/Site investigator: The study and site investigator can view study settings, organization and sites, view user & roles, consent forms, invite, view non PII and PII, edit and sign ICF, and view audit trail for a study or site respectively.

Study/Site monitor: The study and site monitor can view study settings, organization and sites, view user & roles, consent forms, view non PII and PII, and view audit trail for a study or site respectively.

Study/Site read-only: The study and site read-only role allows to view study settings, organization and sites, view user & roles, consent forms, view non PII, and view audit trail for a study or site respectively.

Adding a user

To grant account access to the study for a new user, follow the steps below:

1. Click ‘Add user’ button
2. In the ‘Invite user’ window, add the user details:

Email: The email address of the user

Role: Specify a role which a user needs to have for All sites or a specific site

Sites: Choose sites for which the role should be applicable. By default All Study roles (Study Admin, Study Monitor, Study Investigator, and Study Read-only) are granted access to all sites. 

Add another: This will allow the addition of other role options for the user. 

3. Click ‘Invite user’ to send an invite or ‘Cancel’ to cancel the invitation.

Managing existing users

The ‘Options’ column allows you to edit roles for existing users that have been invited to the study as well as to resend invites.

In the ‘Options’ column, click on the ‘Manage’ button to access the ‘Manage user’ window:

Once you have edited the user details, click on the ‘Save changes’ button to apply changes.

It is possible to resend an invitation to a user who has not yet accepted the invitation by clicking on the three dots menu in the ‘Manage user’ window.