Below is a list of commonly asked questions about Veeva SiteVault.
Yes. You can use SiteVault Free for any study, regardless of the funding source, as long as you’re working as the investigator.
SiteVault Free will always be free. Veeva also offers a version of SiteVault, SiteVault Enterprise
, which includes additional features, including configurable workflows, self-service reports, open API for integration, Single Sign-On, and more.
There is not a limit on the number of studies, documents, or users that you can have in SiteVault.
SiteVault is built to handle files of all types of media, including videos. A single file size has a four-gigabyte limit.
SiteVault utilizes Amazon Web Services for our primary cloud infrastructure. This includes backup and redundancy capabilities. You can learn more here: https://www.veeva.com/trust/
SiteVault Free is fully validated by Veeva, and all validation documentation will be made available to customers from within the application.
Yes, support (phone and email) is available from Veeva. Support will initially be offered during U.S. business hours.
Yes, this resource kit
provides information to help you learn more and create a business case to present SiteVault Free to management.
The process for getting setup involves three simple steps:
- Once signed up, a member of the Veeva team will connect with you over the phone or via email to confirm your interest, timeline to get started, and confirm who has the authority to sign the Terms of Service.
- You will receive a Terms of Service agreement to review and sign (FDA regulations require that any vendor providing services to a regulated entity must have an agreement).
- Once the Terms of Service is signed, the primary contact will receive a welcome email and a user account with permissions to add additional users and access to all of the training resources and help documentation to get started.
No. SiteVault Free is a web-based application that can be accessed from any internet-connected computer or mobile device.
Features and Functionality
Yes, if you have a document, such as a CV that’s linked with an investigator, and you add a new version, the document will be updated across all of the investigator’s studies.
At this time, there is only a single folder structure in the eBinder view of SiteVault Free. Using a standard folder structure helps all users of SiteVault Free (including Sponsors, CROs, Auditors, and Inspectors) to quickly find what they are looking for and more easily identify missing files.
Yes, the eSignature workflow is available for the following documents: CV, Protocol Signature Page, Form FDA 1572, Acceptance of IB, Financial Disclosure Form.
Sites can upload a copy of an ink-signed document using the certified copy workflow. SiteVault Free includes a certified copy workflow that can be used in cases like this.
SiteVault Free does not currently integrate with other systems. However, SiteVault Enterprise
has an open API that enables integration with other systems.
A system administrator or Regulatory manager at the site can grant access for the PIs, study team members, and monitors.
There are three types of users in SiteVault Free: Regulatory, Study Team, and External (Monitors, Auditors, Inspectors). Of these, only the Regulatory user type can create additional users for a site. Regulatory users will control access to the system.
After creating a Study Team or External user, a Regulatory User can assign them to one or more specific studies. This assignment allows that user to see or edit documents & information for those studies.
SiteVault supports frequently used features on Apple iOS and Android with Safari and Chrome web browsers (respectively). Some document markup and advanced features may not be available when accessing the system from a mobile phone or tablet.
SiteVault automatically maintains version control to ensure that teams can confidently work and collaborate on the current version of a document, while still accessing prior versions. Older versions of a document cannot be changed.
Working with Sponsors and CROs
Yes, monitors have been very receptive and are actively using SiteVault to access regulatory files. Additionally, many monitors have given positive feedback when given the ability to check for documents remotely as it saves them time so they can spend more time interacting with coordinators or reviewing subject information.
Yes, SiteVault can be used for any study and, monitors can be granted access regardless of which company they work for.
SiteVault is used to manage site regulatory binders or the Investigator Site File (ISF) across all types of clinical research, such as industry-sponsored, Federally funded and single-site Investigator Initiated Trials (IITs). If you are acting as an investigator on a trial, SiteVault is for you. This can include CROs and AROs running Phase 1 units. If you are in the role of a sponsor in clinical research Veeva’s Clinical Operations applications are built for you.
If you have any questions or would like to discuss how we can support you, please contact us.
This content is intended for informational purposes only and does not form part of any contract. It is not a commitment to deliver any specific functionality. Features and functions described in this document will be released commercially only when and if they become available. The development, release, and timing of the features or functionality of Veeva’s products remain at the sole discretion of Veeva.