The Restricted document functionality allows sites to limit document visibility to specific users assigned to the study. The feature is intended to be used for blinded/masked studies where certain documents (ex. randomization information) must remain hidden from the larger study staff. Restricting documents and staff is a two-step process that includes first marking individual study documents as Restricted and then granting individual study staff members access to Restricted documents. Only study staff members with access to Restricted documents can view study documents marked as Restricted.

Summary

• Restricted documents are visible only to Staff or Monitors/External Users granted access to Restricted documents at the study level. Administrators must also receive study-level access to Restricted documents to view Restricted documents.
• Administrators can grant or revoke a study staff member (including themselves) or monitor/external user’s access to Restricted documents. Granting/revoking restricted access must be performed per user, per study.
• Admins and Study staff with access to Restricted documents for a study can:
  • View, edit, and approve/finalize restricted documents for the study
  • Upload documents as restricted via the Study eBinder
  • Toggle a document’s restrictedness from the Document Actions menu
• All study-specific documents can be restricted; non study-specific/multi-study documents such as CVs, licenses, etc., cannot be restricted.
• Restricted documents cannot be sent on workflows.
• Before study archival can be completed, all Restricted study documents must be unrestricted (changed to Not Restricted). The Study Archive action includes a check for Restricted documents.
• Restricted documents can be exchanged through Site Connect, however, it is important to note that for full Restricted visibility and functionality in both environments a connected user should have access to Restricted documents in both Site Connect and SiteVault. For more information on Site Connect activity and permissions, see SiteVault and Site Connect.

Mark a Document as Restricted or Not Restricted

Staff users granted access to Restricted documents can mark documents as Restricted by:

• Setting the Restricted field to Yes when uploading a document to the Study eBinder
• Selecting Change to Restricted from Document Actions menu

From Study eBinder Upload

To upload a document to the Study eBinder as Restricted, select Yes from the Restricted field during the upload process.

From Document/All Actions

To toggle a document’s restrictedness, access the document and select either Change to Restricted or Change to Not Restricted from the Actions menu (…).

Grant or Revoke Access to Restricted Documents

Administrators can grant or revoke user access to Restricted documents (including their own) when adding or editing Staff or Monitor and External User study assignments from the Study or Administration tabs.

From the Study

Administrators can grant or revoke study-level access to Restricted documents from Study tabs for:

• Staff when adding or editing a Team Assignment from Study > Team
• Monitors and External Users when adding or editing a Study Assignment from Study > Monitor & Auditors

From Administration

Administrators can grant or revoke study-level access to Restricted documents from the Administration tab for:

• Staff when creating a user or adding a Study Assignment from Administration > Staff
• Monitors and External Users when creating a user or adding Site Access and a Study Assignment from Administration > Monitors & External Users

Restricted Permissions in Site Connect and SiteVault

Site Connect and SiteVault permissions are managed by different systems and administrators; a user’s access to restricted documents in one system does not guarantee the same access is assigned in the other. See the table below for the expected behavior based on different permission combinations.

Restricted Permissions	Site Connect Behavior	SiteVault Behavior
No Restricted Access	Cannot view restricted documents. Cannot upload restricted documents from computer. Cannot upload restricted documents from SiteVault.	Cannot view restricted documents. Cannot file restricted documents received in Site Connect to SiteVault and view them once filed.
Restricted Access in Both	Can view restricted documents. Can upload restricted documents from computer and view them. Can upload restricted documents from SiteVault into Site Connect and view them once uploaded.	Can view restricted documents. Can file restricted documents received in Site Connect to SiteVault and view them once filed.
Restricted Access in Site Connect No Restricted Access in SiteVault	Can view restricted documents. Can upload restricted documents from computer and view them once uploaded. Cannot upload restricted documents from SiteVault.	Cannot view restricted documents. Can file restricted documents received in Site Connect to SiteVault, but cannot view them once filed.
No Restricted Access in Site Connect Restricted Access in SiteVault	Cannot view restricted documents. Cannot upload restricted documents from computer. Can upload restricted documents from SiteVault but cannot view them once uploaded.	Can view restricted documents Cannot file restricted documents received in Site Connect to SiteVault and view them once filed.