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.
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 eRegulatory. 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 eRegulatory 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
Sign Up for SiteVault
Let’s go! If a specific study has brought you here, be mindful of the study timeline and gain access to Veeva SiteVault as early as possible. The sooner you grant access to your study team, the sooner they can experience the system and start connecting with your study partners.
Before you sign up, confirm whether anyone at your organization has previously used SiteVault. If so, contact the current SiteVault user to gain access to the SiteVault. If the current SiteVault user is no longer at your organization, complete the User Role Change Request form to get started. Should you need assistance identifying the current SiteVault user at your organization, please reach out to our Site Support team.
If your organization is new to SiteVault, please complete the SiteVault sign-up form. The registration form will collect pertinent information about your site and require you to sign a Terms of Service. When signing up, please provide the name of the sponsor or CRO you are working with in the How did you hear about SiteVault field.
The site staff member who completes the sign-up form is designated as the initial Site Administrator for your SiteVault account. The initial Site Administrator can later assign other users as additional Site Administrators.