Frequently Asked Questions

Veeva is on a mission to make clinical trials more efficient and improve patient participation by connecting sites, sponsors, and patients on a single technology ecosystem.

Veeva SiteVault is part of this ecosystem. We believe that sites need access to affordable, easy to use technology that connects them to sponsors and reduces the number of systems and logins used to run clinical trials.

We are able to offer SiteVault for free for two reasons:

1.) Sponsors cover the costs for many studies – Since over 400 sponsors and CROs use Veeva applications to run their trials, Veeva charges these sponsors when they choose to connect with sites using Veeva SiteVault. This removes the need for sites to bill them directly.

2.) As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and the industries it serves. Offering SiteVault for free provides long-term value for clinical researchers and benefit society by enabling the advancement of clinical trials.

As a Public Benefit Corporation, Veeva has a legal responsibility to balance the interests of multiple stakeholders, including customers, employees, partners, and shareholders. We want to help make the industries we serve more productive – and one of the ways we do that is by offering SiteVault at no cost to research sites around the world.

Over time, Veeva may develop new functionality that is available within SiteVault for an additional cost. As an example, sites may upgrade to the Enterprise version or purchase Veeva eConsent. Our intention is to keep the core eRegulatory and Connected Study functionality available at no cost.

Yes. You can use Veeva SiteVault for any study, regardless of the funding source, as long as you’re working as the investigator.

There is no limit on the number of studies, documents, or users that you can have in Veeva SiteVault.

Veeva SiteVault is built to handle files of all types of media, including videos. A single file size has a four-gigabyte limit.

Yes. Comprehensive support (phone,email, and chat) training, and YouTube tutorials are available to customers at no cost.

Customers also receive a dedicated Site Success team with clinical research experience to assist with change management, onboarding, and product feedback.

Yes, this resource kit provides information to help you learn more and create a business case to present Veeva SiteVault to management.

Veeva maintains the SiteVault software in a validated state consistent with the life sciences regulatory requirements (including 21 CFR Part 11 and Annex 11). We perform the software validation and summarize our findings in a validation summary report, which customers can request.

We have designed a comprehensive security program based on ISO 27001 to ensure the confidentiality, integrity, and availability of SiteVault customer data. We regularly pass rigorous third-party compliance audits of our robust security, confidentiality, and availability controls and publish a Service Organization Controls 2 (SOC 2) Type II report.

We ensure our data processing commitments comply with the GDPR and other applicable data protection laws and give SiteVault customers an easy, electronic way to sign up to our Privacy & Security Processor addendum setting out those commitments.

US SiteVault customers who are covered entities can use the software to process, maintain and store protected health information in accordance with Health Insurance Portability and Accountability Act (“HIPAA”). As part of our standard terms of service, we agree to the terms of our business associate addendum that accounts for the services we provide to our customers.

Finally, we use Amazon Web Services (“AWS”) as our primary cloud infrastructure provider. In addition to AWS’ robust compliance program, we have signed the appropriate agreements with AWS as required under the applicable laws. We use AWS infrastructure based on our customer’s location to store customer data: in the United States (West and East Coast), in Europe (Germany and Ireland), or in Japan.
For more information, read our privacy and customer data statements and the Veeva SiteVault Technical and Operational Security Whitepaper.

Yes. Sites have access to all of the validation documentation and Technical and Operational Security Whitepaper from within Veeva SiteVault.

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).

In Veeva 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.

For information about how Veeva addresses privacy and customer data, see our Privacy Statement and Veeva and Customer Data.

Yes. If you have a document, such as a CV that is 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 Veeva SiteVault. Using a standard folder structure helps all SiteVault users 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. Veeva SiteVault includes a certified copy workflow that can be used in cases like this.

The Enterprise version has an open API that enables integration with third-party systems.

The free version of SiteVault integrates with other Veeva applications but does not currently integrate with third-party systems.

A Site Administrator has full access to all data and documents for the site. They can create and manage user accounts for the site including investigators, study team staff, and monitors.

There are three types of users for the Research Organization level and the Site level in Veeva SiteVault: Administrator, Staff, and External (Monitors, Auditors, Inspectors). Of these, only the Administrator user type can create additional users for a research organization or site. Administrators will control access to the system. After creating a Staff or External user, an Administrator can assign them to one or more specific studies. This assignment allows that user to see or edit documents & information for those studies. In addition, one or more Add-On permissions can be added to the Research Organization Staff and Site Staff system roles to extend a user’s access to certain data and documents.

The free version of Veeva SiteVault will retain study data for 25 years following the date of study creation. SiteVault Enterprise will retain study data indefinitely or as long as you own the application.

To sign up, complete this form and be sure to add your department or location if you are part of a larger organization. Your account will be created typically within one to two business days. If you have any questions, please contact SiteVault Support and a member of the team will connect with you over the phone or via email to assist you.

As part of the signup form, you must 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 created, the primary contact will receive a welcome email and a user account with permissions to create additional users access to the system. You will also have access to all of the training resources and help documentation to get started.

No. Veeva SiteVault is a web-based application that can be accessed from any internet-connected computer, tablet, or mobile device.

Veeva 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.

Veeva eConsent may be provided by your sponsor for a study or enabled within your Veeva SiteVault account to use across all studies. Contact us to learn more.

Yes. Veeva eConsent is not a sponsor-specific platform, which allows you to standardize your SOPs, workflows, and training for consenting across all studies to improve compliance and efficiency. Learn more about the benefits of a standard eConsent solution here.

The best way to gain acceptance from your IRB or sponsor is by communicating how it will streamline processes and benefit your patients. Here are a few examples:

• Improve patient retention and satisfaction by providing a convenient way to provide consent and access study documentation.
• Enhance comprehension and knowledge retention with an easy-to-navigate system that supports images, videos, and questions.
• Improve safety and compliance by allowing for timely collection of the subject’s consent data from remote locations and rapid notification to the subject of any amendments pertaining to the informed consent that may affect their willingness to continue to participate.

You can also provide them with the following resources:

• Veeva eConsent Product Brief
• eConsent SOP (template available here)
• Validation Documents
• Technical and Operational Security Whitepaper

Lastly, you can share a preview of the consent form with your IRB or sponsor within SiteVault so they can review the patient experience.

Demonstrate compliance by establishing SOPs. This will serve as a resource for training staff and reinforce your site’s commitment to quality assurance. Veeva provides an SOP template for eConsent.

Provide security and validation documentation. Provide the Technical and Operational Security Whitepaper and Validation Documents to your sponsor or IRB to further demonstrate compliance.

Understand the regulations. The FDA regulations permit investigators to use electronic informed consent, as long as the process facilitates the patient’s comprehension and ensures data quality and integrity. Learn more about the FDA guidelines here and the OHRP guidelines here.

Yes. While you must sign up for Veeva SiteVault to get access, you can choose to only use the eConsent functionality within SiteVault on all studies or only specific studies, if desired.

Yes. Veeva SiteVault can be used for any study, regardless of funding source. You can grant all monitors access to your SiteVault, regardless of which company they work for.

SiteVault is used to exchange study information with sponsors and 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, Veeva 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 applications are built for you.

Sites control access to Veeva SiteVault by outside monitors and auditors. Sites manage the access by outside monitors and auditors, and sites determine which documents, including regulatory and source documents, are shared with them. For additional information about how Veeva addresses privacy, see Veeva’s Privacy Policy.