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Managing a Site-Owned System

Congratulations! You’ve made a great decision for your site and for the future of clinical research. SiteVault is built for YOU, the site, to connect with one sponsor on one study or to manage all of your studies across all of your sponsors. Veeva SiteVault is site-owned and managed. This means you manage access to the system, are responsible for adding staff, and can decide your site’s level of use.

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.

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

• Study eBinder to easily manage and track your study documentation progress
• Site Documents eBinder to organize and manage your site business documentation (non-study-specific)
• Document workflows (for example, eSignature, certified copy, training, and more)
• Digital delegation to generate your Delegations of Responsibilities Log
• Monitoring tools and workflows
• Reports and dashboards

The Study Connect application is an intuitive tool that has simplified the study-related interactions between sites and their study partners. Sponsors/CRO using Veeva’s technology can invite you to connect on a study using SiteVault’s Study Connect application. Study Connect offers solutions in the following areas:

• Document Exchange
• Safety Distribution
• eConsent
• ePRO