Release Notes

Generate FDA 1572

This feature introduces the ability to generate a FDA 1572 form within Site Connect. By leveraging existing CTMS data—specifically information captured within the Site Profile such as Site Staff and Site Addresses—the system pre-populates the form.

Site Connect users can manage the form via a new Forms tab located on the Document Exchange page. The interface is organized by sections that mirror the physical FDA 1572 layout and provides dynamic editing capabilities. Users can manually add missing information, such as adding new Site Addresses, or remove pre-populated addresses that are not applicable. The document can also be e-signed within the Site Connect UI. Alternatively, site users can download the form to edit and sign manually if a wet ink signature is required, then re-upload the completed document.

If the Site is connected to SiteVault, the 1572 can be automatically filed in the ISF.

Removed Site Connect Document View for Obsolete & Deleted State Types

This feature prevents Site Users from accessing the content of exchanged documents that have reached a lifecycle state that’s associated with the Obsolete or Deleted state types.

The document row will remain visible in the Document Exchange section, but the content itself is restricted. If a user selects the name link, the document viewer will state that the document is no longer available.

The same behavior will apply when selecting document links within document exchange email notifications.

Site Home User Interface Improvements

This feature adds several user interface enhancements to the Site Home Page.

• The column order within Study Contacts has been updated to provide a more intuitive view of Contact Information. Email Address now appears immediately following Contact For, and Office Phone has been relabeled to Office.
• When hovering over a recalled document in Document Exchange, the hover text will now dynamically display the specific Reason for Recall entered by the Sponsor or CRO. Previously, a generic message displayed stating that the document was no longer accessible.
• The error messages have been standardized when a download fails from either the PAL document viewer or Authenticated Document Links

Failed Safety Distributions Visible in Site Home

Safety Distributions in the Failed state are now visible within Safety Distribution and Document Exchange. The documents can be marked as Read by recipients completing distribution tasks. This allows for better visibility and management of exchanged safety documents.