Frequently Asked Questions
Review commonly asked questions about Veeva SiteVault.
Pricing and Support
Is SiteVault Free free available to sites that do academic research as well as pharma trials?
Yes. You can use SiteVault Free for any study, regardless of the funding source, as long as you’re working as the investigator.
Do you anticipate that there will be charges eventually for SiteVault Free? Or charges for additional features?
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.
Is there a limit for the number of studies, documents, or users that can be managed in the system?
There is not a limit on the number of studies, documents, or users that you can have in SiteVault.
Is there a size restriction for the types or size of files that can be added?
SiteVault is built to handle files of all types of media, including videos. A single file size has a four-gigabyte limit.
Is the system secure and backed up?
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/.
Are there resources for validating SiteVault Free?
SiteVault Free is fully validated by Veeva, and all validation documentation will be made available to customers from within the application.
Is support included with SiteVault Free?
Yes, support (phone and email) is available from Veeva. Support will initially be offered during U.S. business hours.
If I would like to present SiteVault Free to management, is there any material that I can present to them?
Yes, this resource kit provides information to help you learn more and create a business case to present SiteVault Free to management.
What is the process to implement and get access to SiteVault Free?
To sign up, complete this form and a member of the Veeva team will connect with you over the phone or via email to confirm your information. Your account will be setup within one business day.
As part of the sign up form, you will need to review the Terms of Service, as FDA regulations require that any vendor providing services to a regulated entity must have an agreement in place.
Once your account is setup, 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.
Do I need to install any software to use SiteVault?
No. SiteVault Free is a web-based application that can be accessed from any internet-connected computer or mobile device.
Features and Functionality
If I file a document in one place, will it auto-populate to all of the relevant locations?
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.
Can you change the names of the folders in SiteVault Free?
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.
Can you request signatures for study documents (e.g., 1572, financial disclosure forms, etc.) within SiteVault?
Yes, the eSignature workflow is available for the following documents: CV, Protocol Signature Page, Form FDA 1572, Acceptance of IB, Financial Disclosure Form.
How do you deal with countries where electronic signatures are not acceptable?
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.
Can SiteVault Free integrate with other systems?
SiteVault Free does not currently integrate with other systems. However, SiteVault Enterprise has an open API that enables integration with other systems.
How are PIs onboarded to Veeva SiteVault?
A system administrator or Regulatory manager at the site can grant access for the PIs, study team members, and monitors.
How many user groups are available in SiteVault Free?
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.
Will accessing SiteVault on a cell phone or tablet work the same as if used on a laptop or desktop?
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.
When documents are updated, can older versions be edited or changed?
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
Can I use SiteVault with any sponsor or CRO?
Yes, SiteVault can be used for any study and, monitors can be granted access regardless of which company they work for.
Who owns and controls the data stored in SiteVault?
In SiteVault, the customer site owns and controls their own data, including regulatory and source documents, except as provided in our Terms of Service or as may otherwise be required by law. The sites decide what documents to share and with whom to share them.
Who controls access for remote monitoring?
Have monitors been receptive to using the system instead of asking coordinators to send documents to them directly?
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.
Can sponsors/CROs use the system?
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.
Can you describe SiteVault Free’s technological and operational security?
This document describes the technology, practices, and controls that Veeva uses to keep your data secure in Veeva SiteVault Free.
How is SiteVault validated?
SiteVault is built on Veeva Vault which has been validated by Veeva Systems in accordance with industry-standard validation guidelines and regulations (e.g. 21CFR820.75, 21CFR211.68, 21CFR11, EU Annex 11).
Do sites using SiteVault Free have access to validation materials?
Yes. Sites have access to all of the validation documentation from within the SiteVault Free system.
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.