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SiteVault System Information

Veeva SiteVault is fully validated by Veeva and supports compliance with 21 CFR Part 11, HIPAA, Annex 11, and GDPR. We know that system documentation is important, which is why you can access a SiteVault validation certification document anytime to demonstrate security and compliance for any of your study partners.

In preparation for using a new tool, Veeva recommends that you update your own internal documentation as well. Consider creating new or revising any existing standard operating procedures (SOPs).

SiteVault Applications

SiteVault is comprised of two applications: Study Connect and eISF. These apps can be used independently or together. You are currently in the Study Connect section of the SiteVault Help Center. You are likely here because you have been invited to participate in a study in which the sponsor or CRO is requesting the use of SiteVault’s Study Connect application.

The Study Connect application is an intuitive tool that has simplified the study-related interactions between sites and their study partners. Study Connect offers solutions in the following areas:

• Document Exchange
• Safety Distribution
• eConsent
• ePRO

SiteVault’s eISF application is a powerful solution for managing all of your site’s study activity across all of your studies. In this one application, you can find the following features:

• Regulatory eBinder
• Document workflows (for example, eSignature, certified copy, training, and more)
• Digital delegation
• Monitoring
• Reports and dashboards
• Full connectivity with the Study Connect application