Research Resources

Veeva SiteVault

All Human Subjects Research studies and expanded access programs with IRB approval dates on or after September 30, 2024, are required to utilize Veeva SiteVault as their e-regulatory binder solution.

What is Veeva SiteVault?

Veeva SiteVault is an electronic investigator site file designed to streamline regulatory management. It reduces the administrative burden by eliminating the need for paper binders and signatures while ensuring compliance with 21 CFR Part 11 and HIPAA. Veeva SiteVault can be used across all study types.  
 
This system allows research teams to save time and reduce risk by establishing consistent version control and record-keeping processes that allow for easy exchange of information with study monitors.

Key Features

  • Electronic regulatory and patient binders: Securely store and manage essential documents.
  • Remote monitoring: Grant study monitors controlled access to view regulatory and patient source documents.
  • eSignatures: Investigators and study teams can electronically sign and approve documents.
  • Digital delegation: Add study team members and obtain principal investigator approval within the system.
  • Central document repository: Licenses, certifications, and CVs automatically update across relevant studies with each new version.
  • Reports and dashboards: Track expiring documents and eSignature turnaround times, monitoring activity, and more.
  • eConsent: Streamline the electronic informed consent process. 

Direct Login

Veeva SiteVault Website
Note: You must be on the Lurie Children’s network to log in.

Yes. Effective September 30, 2024, all studies and expanded access program with IRB approval dates on or after this date are required to use Veeva SiteVault as their e-regulatory binder solution. 

For detailed requirements and standard procedures, please refer to the Veeva SiteVault eRegulatory Policy.

For guidance on which types of documents must be filed in Veeva SiteVault based on study type see the Veeva SiteVault SOPs.

Yes, research professionals must complete the Research Education Learning Modules—Introduction to Veeva SiteVault New Users course in Workday before requesting access.

Note: New staff will automatically be enrolled as a part of RP orientation. 

Submit a service request if you need to:

  • report an issue.
  • request user access.
  • add a new organization.
  • update an existing organization.