Frequently Asked Questions

Veeva is committed to providing affordable technology and global support to research sites. If a site exceeds 20 concurrent active studies they likely require the additional technical and administrative support provided through our Enterprise program. For additional information please connect with us today.

24×7 live support, self-service guides, and training videos are always available at no cost throughout your SiteVault journey. For sites that are large or complex, we recommend implementation services for a one-time fee to support your transition to SiteVault. Contact us for further details regarding implementation pricing.

Yes. You can use 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 SiteVault.

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 SiteVault to management.

No. There is no cost to manage archived studies. Sites maintain access to archived studies and documents for the 25 year retention period and may provision monitor and audit access as necessary.

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 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 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.

No. The SiteVault eBinder structure is based on the eISF Reference Model and is an intentional product design choice to simplify compliance and bring greater quality and efficiency to site operations.

Using a standard structure helps study staff, monitors, and investigators quickly find what they need and supports interoperability with sponsor systems. Learn more about eISF standardization here.

Yes. You may request and collect eSignatures for documents in SiteVault. The electronic signature in SiteVault is nonbiometric and requires the application of two distinct components (a user ID and password) and is compliant with the Food and Drug Administration’s (FDA’s) 21 CFR Part 11 section §11.200 requirements of electronic signatures that are not based upon biometrics

Yes. Using eSignatures in SiteVault is not required. Instead, users may upload a copy of an ink-signed document and complete a copy certification in SiteVault.

Yes. The SiteVault Enterprise Package enables integration. SiteVault is the only eRegulatory application with an open, publicly available API.

The free version of SiteVault integrates with other Veeva applications but does not currently integrate with third-party systems. This ensures that Veeva can continue performing system validation on behalf of our customers upon each release.

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

Yes. There are three types of users for the Research Organization level and the Site level in Veeva SiteVault: 1) Administrator, 2) Staff, and 3) External. Monitors, Auditors, and Inspectors should be set up as external users.

Administrators can create new users, control access to the system, and assign additional users to studies. This assignment allows that user to see or edit documents and information for those studies.

Additional 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.

Yes, you can store source documents in SiteVault. SiteVault is HIPAA-compliant and capable of storing unredacted documents.

For source documents, SiteVault prompts users to select whether the uploaded document has redactions. Redaction is not required to maintain compliance. Monitors prefer that documents remain unredacted to perform source document verification (SDV) effectively. External users such as monitors or CRAs cannot download source documents.

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

To sign up, complete this form. Only one person from your site needs to sign up.

Your account will be created within two business days. Once your account is created, you will receive a welcome email and access to create additional users.

You will be required to review the Terms of Service (TOS), as FDA regulations require that any vendor providing services to a regulated entity must have an agreement in place.

If you have any questions, please contact our support team.

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

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 eConsent can be enabled within your SiteVault account to use across all studies. Contact us to learn more.

Yes. SiteVault 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.

In addition to updating your SOPs, you can provide them with the following resources:

• Veeva eConsent Product Brief
• 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.

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