It offers a comprehensive solution that enhances the experience for both patients and research sites by providing a more efficient, compliant, and user-friendly approach to managing consent.

Key Features

• Digital Consent Process:
  • In-Person and Remote Consent: Allows participants to provide consent either in-person or remotely, using any device.
  • Interactive Elements: Consent forms can include videos, questions, and other interactive elements to improve understanding and engagement.
• Centralized Management:
  • Vault Integration: Sponsors manage consent forms within Veeva Vault, ensuring centralized control and easy updates.
  • Blinded Data: Sponsors and CROs can view blinded consent data, maintaining participant confidentiality while monitoring consent status.
• Compliance and Security:
  • 21 CFR Part 11 Compliance: Supports electronic signatures and audit trails to meet regulatory requirements.
  • HIPAA Compliance: Ensures that patient data is handled in accordance with privacy regulations.
• Enhanced Patient Experience:
  • Patient-Centric Application: Participants can access and sign consent forms through MyVeeva for Patients, a user-friendly app that also allows them to manage other study-related activities.
  • Convenient Access: Patients can review and sign consent forms at their convenience, reducing barriers to participation.
• Efficiency for Sites:
  • Reduced Administrative Burden: Streamlines the consent process, reducing the time and effort required to manage paper-based consent forms.
  • Real-Time Updates: Sites can easily update consent documents and track participant consent status in real-time.
• Integration with SiteVault:
  • Seamless Workflow: Integrates with Veeva SiteVault, allowing sites to manage eConsent alongside other regulatory documents.
  • Comprehensive Reporting: Provides full visibility into consent status, version control, and audit trails, ensuring compliance and facilitating monitoring.

Benefits:

• Improved Compliance: Ensures that all consent processes meet regulatory standards, reducing the risk of non-compliance.
• Enhanced Patient Engagement: Makes it easier for patients to understand and complete the consent process, improving their overall experience.
• Increased Efficiency: Reduces the administrative workload for research sites, allowing them to focus more on patient care and study execution.
• Better Data Management: Centralizes and secures consent data, making it easier to manage and monitor across multiple studies.

Veeva eConsent is designed to modernize the informed consent process, making it more efficient, compliant, and patient-friendly.