Veeva eConsent: Improved Patient Experience with End-to-End Informed Consent

The video details the functionality and workflow of Veeva eConsent, a solution designed to streamline the informed consent process in clinical trials, thereby improving the patient experience and reducing administrative burden and trial execution time. The system establishes an end-to-end digital process that connects the sponsor, the clinical site, and the patient through the integrated Veeva Vault Clinical and Site Vault platforms. This integration ensures a single source of truth for all informed consent form (ICF) versions, mitigating the risk of sites using outdated documentation and enhancing regulatory traceability.

The process begins at the sponsor level within Vault Clinical, where the eConsent editor allows for dynamic and rich content creation. Sponsors can easily update ICF templates by adding sections of text, utilizing rich text formatting, and incorporating multimedia content such as pictures, videos, or interactive questions (e.g., to gauge future research interest). Crucially, the system supports dynamic signature blocks that adjust based on specific requirements, such as guardian or witness needs per patient. Once edits are finalized, the new ICF version is automatically distributed directly through the system to all connected sites utilizing Veeva Site Vault, ensuring immediate and centralized version control across the trial network.

From the site's perspective, the system provides immediate alerts regarding new ICF versions, allowing site staff to quickly compare changes before seeking Institutional Review Board (IRB) approval. When consenting a new patient, the site user is confident in using the correct, IRB-approved version due to the centralized filtering provided by Site Vault. The site initiates the consent process by sending a link to the patient's email. The patient then accesses the electronic ICF via the MyVeeva app, available on mobile or desktop browsers. The MyVeeva app is designed for easy navigation, capturing the patient's progress and ensuring all required sections are reviewed before the patient provides their signature.

The system provides immediate feedback and tracking across all parties. Once the patient signs off, the document is instantly available in their personal library within the MyVeeva app, consolidating documents across multiple trials if they participate in others. Simultaneously, the site receives an immediate update and notification of the patient’s signature, triggering a subsequent task for the site user to provide their final sign-off, completing the ICF process. All steps, signatures, and completion data are stored as structured data points within Site Vault, which sites can leverage for filtering patient databases or which external monitors can use for efficient remote or on-site monitoring. This integrated approach significantly reduces manual paperwork, accelerates the critical step of informed consent, and provides robust audit trails necessary for regulatory compliance.

Key Takeaways:

• Single Source of Truth for ICFs: Veeva eConsent ensures that the sponsor's Vault Clinical system acts as the centralized source for all ICF templates, automatically pushing new, approved versions to connected Site Vaults, eliminating version control errors at the site level.
• Enhanced Patient Experience via Multimedia: The e-consent editor allows sponsors to move beyond static text by incorporating rich media content (pictures, videos) and interactive question sections, which can improve patient comprehension and engagement with the complex consent process.
• Dynamic Regulatory Compliance: Signature blocks are dynamically generated based on patient-specific or protocol-specific requirements (e.g., guardian or witness signatures), ensuring that the final document adheres to necessary regulatory standards without manual intervention.
• Accelerated Site Workflow: Site users are alerted immediately to new ICF versions and can quickly compare changes, streamlining the process of seeking updated IRB approval and accelerating the time-to-patient enrollment.
• Mobile Accessibility via MyVeeva App: Patients receive eConsent tasks directly via email and can complete the process on the go using the MyVeeva mobile application or a desktop browser, improving convenience and reducing delays associated with scheduling in-person consent meetings.
• Automated Progress Tracking: The MyVeeva app captures the patient's review progress, ensuring they have navigated and reviewed all required sections of the electronic ICF before they are permitted to provide their signature, providing a documented audit trail of review completion.
• Immediate Data Availability for Sites: Upon patient signature, the completion status is immediately updated in Site Vault, triggering the next required task (site user sign-off) and drastically reducing the lag time between patient consent and site confirmation.
• Centralized Patient Document Library: The MyVeeva app serves as a consolidated document library for patients, allowing them to reference their signed ICFs and other trial documents across multiple studies without needing to manage various applications or paper copies.
• Structured Data for Monitoring and BI: All completion steps, signatures, and progress indicators are stored as structured data points within Site Vault, enabling sites to filter their patient database efficiently and providing external monitors with immediate, actionable data for both remote and on-site oversight.
• Reduction of Administrative Burden: By digitizing the entire consent workflow, the system significantly reduces the administrative burden associated with printing, tracking, filing, and verifying paper-based informed consent forms, leading to faster trial execution times.

Tools/Resources Mentioned:

• Veeva eConsent
• Vault Clinical
• Site Vault
• MyVeeva App (mobile and desktop browser access)
• e-Consent Editor

Key Concepts:

• Informed Consent Form (ICF): The critical regulatory document used in clinical trials; the system manages the electronic version (eICF).
• IRB (Institutional Review Board): The committee responsible for reviewing and approving clinical trial protocols and ICFs before they can be used at a site.
• Single Source of Truth: The principle that all data and documentation (in this case, ICF versions) originate from and are synchronized with one central system (Vault Clinical), ensuring consistency and compliance across all connected sites.
• Remote Monitoring: The ability for sponsors or CROs to review essential trial documentation, such as signed ICFs and completion data, without needing to physically visit the clinical site, facilitated by the structured data in Site Vault.