Site Specific Security

When providing site users access to a study, it is important that security is automatically assigned to ensure that users can complete their tasks, such as document upload, certification, redaction, indexing, reconciliation, with the regulatory binder, and sharing to the eTMF while preventing access to material that they are not authorized to see.

Upon creation of a new user, a designation of Site User can be given to the user, along with an assignment to one or more specific sites. A user can have, therefore, a Reader-level access to one site but Editor level to another. To perform this assignment, invite a new user from the Users Management panel in an eISF room using the Regular method of an invite. See the screenshot below.

1. Select Yes under “Is this a Site User?”
2. Choose an Investigative Site, followed by the Contact Type to be assigned to the user for that Site.
3. Select whether the user should have Reader- or Editor-type access to the Site.
4. Mark the Access to Restricted Folder box if you wish the user to have access to the site Subject Documentation and other source documents.
5. You can repeat these steps for multiple Sites. Use the ‘+’ button at the right to add a new line.

Specific permissions are assigned to users in this category based on predetermined site template-folder security configuration. This will allow users to be provided the correct security profile right away upon creation and gain immediate access to the Site Collaborate room, reducing time-to-access.

Given the stringent security requirements typical for a Site Collaboration (eISF) environment, we recommend the creation of new users in this type of room be handled by the Trial Interactive Service Desk in accordance with your previously defined security setup.