SiteVault FAQs

Answers to some of SiteVault’s most frequently asked questions (FAQs).

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This page provides answers to FAQs about getting started with and the basic functionality of SiteVault. To view more FAQs about other workflows and features of SiteVault, see the following pages:

• Documents: Answers to FAQs about working with documents in SiteVault.
• Managing Users: For Site Administrator users, answers to FAQs about creating SiteVault user accounts and managing system access and permissions for staff members at your site.
• Patients and Participants: Answers to FAQs about managing patients and participants in SiteVault.
• Monitoring: Answers to FAQs about using SiteVault for monitoring.
• Studies: For Site Administrator users, answers to FAQs about working with studies in SiteVault.
• Veeva eConsent: Answers to FAQs about Veeva eConsent.

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• How do sites sign up for SiteVault?
  Complete the signup form on the Veeva for Research Sites website to sign up for SiteVault.
• What is a SiteVault Universal Site Number (USN) and where do I find it for my research site?
  

  The USN is a unique number for your site that is assigned by Veeva after your SiteVault signup is approved. It can be used by sponsors or CROs to connect to your SiteVault to exchange documents and information on Connected Studies.

  To find your USN:

  • eReg Application: Navigate to the Administration > Sites tab and select the record for your site. The USN is displayed in the USN field in the Details section.
  • Study Connect Application: You can find your USN by positioning your pointer over the site name in the upper-right corner of SiteVault.
• How do I access training for SiteVault?
  Live and on-demand training resources are available on the Training Resources page.
• Is SiteVault 21 CFR Part 11, GDPR, and HIPAA compliant? Is a certificate available that I can provide to my sponsor or CRO to demonstrate this?

  SiteVault is compliant with 21 CFR Part 11, GDPR, and HIPAA.

  • 21 CFR Part 11 and GDPR: Compliance is covered in the Technical & Operational Security Whitepaper for SiteVault. The whitepaper also covers electronic signature compliance. See the Veeva and GDPR page on the Veeva website for more information on Veeva's compliance with GDPR.
  • HIPAA: Compliance is covered in the SiteVault Terms of Service. Handling of protected health information (PHI) is specifically covered in the Exhibit B (the Business Associate Addendum) portion of the Terms of Service.

  You can download the documents above and send them as attachments to your sponsor or CRO to demonstrate compliance.

  See the Validation Documents page if you need information or documentation on the validation of SiteVault.

• How do I reset my password?
  See the help for changing your password to learn how to reset your password.
• How do I switch between sites?
  See the help for using the vault selector to learn how to navigate among your research organization and site or sites in SiteVault.
• Why does my PI need to have a SiteVault account and log in?
  Regulations require that the PI have oversight over all aspects of the trial including the ISF. When logged in, your PI can take full advantage of SiteVault’s capabilities, for example, complete training workflows, sign documents electronically, and oversee digital delegation.
• What's the difference between views and filters?

  

  Views enable you to view a subset of documents or data records based on standard SiteVault settings or other saved searches and filters. You can save and share custom views based on your current search, filters, or other view settings. Note that SiteVault remembers the view that you last selected for a tab and opens it automatically when you open the tab.

  Filters enable you to refine the list of documents or data that are displayed in any view or search results. For example, you can filter a list of documents by document type, participant, status, and more.

• How do I create a custom view or apply filters in a tab?

  To create a custom view, complete one or all of the options below in the All Documents, All Studies, or any other view where custom views are available, then select Save View As. Enter a name and optional description for the view in the dialog box, then select Save.

  • Set a layout such as Detail or Thumbnail that you want to use for the custom view. If using the Grid view, you can also add or remove columns.
  • Use the search bar or Advanced Search dialog box to set up a search.
  • Use the Filters panel to set additional filter criteria.
  • Set a sort order.

  To filter any current view or search results, select options from the preset filters in the Filters panel or select Edit () to add additional filters.

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Related Help

• Overview of Digital Delegation
• Overview of Documents
• Documents FAQs
• Monitoring FAQs