SiteVault eConsent

SiteVault eConsent is designed to simplify the clinical trial consent process by offering a digital solution for consenting participants either in-person or remotely. This approach eliminates the need for traditional paper documents, allowing patients to engage with a convenient, modern digital consent process. The system is validated by Veeva and aligns with HIPAA, 21 CFR Part 11, and other regional data privacy regulations, ensuring compliance.

Offering a better patient experience, SiteVault eConsent allows participants to access study documents and information on their personal devices, removing the requirement to manage paper documents. The digital consent reduces the administrative load on staff by streamlining document management, simplifying screening processes, and providing easy access to consent forms across multiple studies.

Key Benefits and Features

• Flexible Consent Options: In-person or remote consent on any device, with signed forms stored in the participant's app.
• Compliant eSignatures: Fully compliant with 21 CFR Part 11 for both patients and study staff signatures.
• Comprehensive Reporting: Full visibility of consent status, dates, and versions, enhancing compliance monitoring.
• Version and Audit Controls: Automated document versioning with timestamps for traceability and compliance.
• Focused Review: User-friendly layout to guide patients through all consent sections before signing off.
• Sharing and Collaboration: Simplified collaboration on informed consent forms between sponsors and sites.
• Quick Onboarding: Rapid upload and consent form readiness, allowing participants to be consented in minutes.
• Template Flexibility: Reusable eConsent templates that accommodate multiple signers.
• Seamless Integration: Manage eConsent across studies via SiteVault, reducing administrative and training demands.

With SiteVault eConsent, clinical trial sites benefit from smoother operations, reduced errors, and enhanced compliance, making the consenting process easier and more efficient for both staff and participants.