Veeva eConsent Overview 2025

This video provides an in-depth overview of Veeva eConsent, highlighting its capabilities in streamlining the informed consent process for clinical trials while ensuring strict regulatory adherence. The primary purpose of the system is to enhance efficiency and compliance by digitizing the traditionally manual and paper-heavy consent workflow. The presentation establishes that Veeva eConsent, integrated within the Veeva SiteVault platform, is already validated with supporting documentation, allowing site staff to quickly adopt and utilize the system without extensive preparatory work. This immediate readiness is a significant value proposition for sites focused on accelerating study startup and maintaining audit readiness.

The core functionality revolves around the eConsent editor, which allows site staff to rapidly convert an IRB-stamped PDF consent document into a fully compliant electronic format within minutes. The system supports various interactive elements, such as checkboxes and radio buttons, and crucially, offers the ability to mandate responses, ensuring that no critical information or required participant decision is overlooked. This feature minimizes the risk of incomplete documentation, a common finding in regulatory audits. Furthermore, Veeva eConsent supports a comprehensive selection of signatory options to accommodate diverse study protocols and global regulatory requirements. A key operational efficiency is that the eConsent setup is a one-time process, enabling the consent of multiple patients across the entire study based on that single configuration.

Operational risk mitigation is a central theme, particularly concerning version control. When initiating the eConsent process, the system actively minimizes the risk of consenting a participant on an outdated or incorrect version of the document, a critical compliance safeguard. The platform is designed for flexibility, supporting both in-person and remote consent scenarios to accommodate the technology preferences and geographical constraints of all participants. During the consent review, the system guides the participant, flagging pages that have been reviewed and clearly indicating where additional responses are required, enhancing participant comprehension and ensuring thorough review. The resulting electronic signatures, names, and dates are explicitly stated as 21 CFR Part 11 compliant, eliminating common issues associated with handwritten documentation, such as illegibility and incorrect date findings. Once signed, the e-consents are instantly available in SiteVault for quick review and counter-signature, with the system automatically filing the completed document, sending a copy to the participant, and updating the real-time consent status. This automation ensures that study teams remain prepared for monitoring visits or the implementation of new consent versions by providing immediate visibility into participant consent status and version history.

Key Takeaways: • Validated System for Rapid Deployment: Veeva eConsent is provided as a validated system with supporting documentation, allowing site staff to bypass lengthy validation procedures and immediately begin using the tool, significantly accelerating study startup timelines. • Automated Compliance Filing: Upon uploading an IRB-stamped PDF consent form, Site Vault automatically files the document in the correct location within the eBinder, ensuring alignment with regulatory requirements and maintaining an organized, audit-ready structure. • Rapid Digital Conversion: The eConsent editor allows site staff to convert traditional PDF consent forms into interactive, compliant e-consents within minutes, supporting features like mandatory checkboxes and radio buttons to ensure complete documentation. • 21 CFR Part 11 Compliance: The system ensures that electronically applied names and dates are fully 21 CFR Part 11 compliant, addressing regulatory requirements for electronic signatures and eliminating legibility issues and dating errors common with paper forms. • Enhanced Version Control: Veeva eConsent minimizes the risk of participants signing an incorrect or outdated consent version, a critical safeguard against protocol deviations and regulatory non-compliance during clinical trials. • Flexibility for Remote and In-Person Consent: The platform accommodates diverse participant needs by supporting both remote and in-person consent processes, optimizing participant recruitment and retention regardless of location or technology access. • Guided Participant Review: The system actively aids participant comprehension by flagging reviewed pages and clearly indicating where additional responses are required, ensuring a thorough and complete review process before signing. • Real-Time Status and Audit Readiness: Signed e-consents are immediately available in SiteVault, which automatically updates the real-time consent status, providing study teams with instant visibility into which participants have signed and which version they used, crucial for monitoring visits and regulatory reporting. • Operational Efficiency through Automation: The platform reduces manual work by automating the filing, participant distribution, and status tracking of completed consent forms, allowing site staff to focus on patient care rather than administrative tasks.

Tools/Resources Mentioned:

• Veeva eConsent
• Veeva SiteVault
• IRB (Institutional Review Board)

Key Concepts:

• eConsent: The process of obtaining informed consent from clinical trial participants using electronic methods, replacing traditional paper forms.
• Veeva SiteVault: A cloud-based application designed for clinical research sites to manage their study documentation, regulatory compliance, and site operations.
• eBinder: The electronic equivalent of the regulatory binder or investigator site file, where all essential study documents are stored and managed.
• 21 CFR Part 11: Regulations set forth by the FDA governing electronic records and electronic signatures, ensuring their trustworthiness, reliability, and equivalence to paper records and handwritten signatures.