Sponsors can use Vault to facilitate the exchange of clinical trial information with study sites. Site users have much of the same document interaction capabilities as standard Vault users. However, Vault behavior for site users is tailored to specifically provide functionality for coordinators, investigators, and other clinical study site personnel.

Multi-Site Document Distribution

With multi-site document distribution (MSDD), sponsors can send a document workflow task to multiple sites at once, track overall workflow completion, and track completion for individual sites. For details about setting up this workflow, see Configuring Multi-Site Document Distribution. For details about starting these workflows, see Multi-Site Document Distribution.

Site User License Type

When creating new Vault users, sponsors can assign the Site User (site_user__v) license type. Only users with the Site User license type see the Site User Homepage, which allows site users to more easily access study information and documents and complete study tasks. Note that site users’ security profiles must also include the Tabs: Home (site_user_home__v) permission in order to access the Site User Homepage and the User: View User Profile permission to view their user profiles.

Sponsors can also manage all site users with the All Site Users (all_site_users__v) standard user group.

About the Safety Information Pane

Admins can configure the Safety Information pane to display on the Site User Homepage, which shows only safety-related tasks such as safety reports a site needs to acknowledge. To enable the Safety Information pane, Admins must navigate to Settings > Application Settings > Site Users and select a Safety Information Document Type Group. The selected Document Type Group should be configured on only safety-related document types. For more information about setting up Document Type Groups, see About Dynamic Access Control for Documents.

Site User Privacy

For increased privacy, site users (users with the Site User license type) are not granted the View User Information permission. Without this permission, site users cannot see identifying details for other site users, including users within their company email address domain. However, site users are able to see identifying details for Sponsor and CRO users whose email address domain matches that Vault’s designated email domain.