Site Documents

You can use SiteVault to manage site-specific, non-study documents such as standard operating procedures (SOP), work instructions, and policy memos. These documents are stored in the Document Library, visible to Staff users once approved. Site Admins can create the documents and use workflows to send them for review, eSignature, and site staff training.

Bulk Assign Staff to Studies

From the Staff Details page (Administration > Staff), an Admin can create Study Team Assignments for one or many studies. This enhancement includes the ability to apply a Study Role to all selected studies with a single click. The Staff Details page contains a new section titled Study Assignments that displays assignments of all statuses, replacing the Active Study Assignments section.

Digital Delegation: Automatically Populate End Date when Inactivating Study Staff

For those using Digital Delegation, this feature expedites the process of inactivating a study staff member by adding their end date to all their delegations. When a Study Assignment state moves to Make Inactive, the user’s delegation End Date-Time fields inherit the assignment end date-time if they are empty or reflect an end date-time after the assignment end date-time. The delegation Start and End Date-Time fields remain editable while the assignment is in the Make Inactive state.

Staff Creation Updates

The Staff creation process is enhanced to display any existing accounts that match the entered email address.

Patient Navigation Update

Staff users can continue to view, create, and edit Patient records by navigating through a study (Participant); however, the Administration > Patients tab will no longer be visible.

Workflow Instructions

When starting a document workflow, the workflow initiator can provide recipients with free-text instructions. These instructions will appear in the All and My Tasks notifications as well as on the document task ribbon.

This feature is available on the following document workflows:

• Read and Understand
• Review Issues Found (Monitor)
• Send for eSignature
• Send for PI eSignature
• Send for Review

Participant ID Code List Document Type Update

The Participant ID Code List document type is now on the Draft to Current - Source document lifecycle. Files associated with this document type cannot be downloaded by external users.