Veeva
The University of North Carolina recently licensed Veeva SiteVault and Veeva eConsent to provide researchers engaged in human subjects research with a standardized, Part 11-compliant, and validated regulatory eBinder and consenting solution.
Veeva SiteVault will streamline creation and management of essential regulatory documents during the research life cycle, including protocols and amendments, ICFs, CVs, delegation of authority, monitoring and training logs, financial disclosure forms, safety information, and FDA 1572 forms. External vendors, auditors and monitors will have project-specific access to these essential documents. The eConsent module will ensure electronic signatures on regulatory documents and patient consents are obtained in accordance with Part 11.
Latest Announcements
The projected go-live for Veeva SiteVault and eConsent is April 1, 2024. If you and your team would like to begin using SiteVault and eConsent for your studies, please create a ticket in ServiceNow and the Veeva team will get you on the schedule.
Contact
Please contact the Veeva Support Team with questions or concerns by filling out the ServiceNow ticket: OnCore and Veeva Help.
Links
Veeva System Overview
Please see the video linked here for a brief demonstration of Veeva SiteVault.