Site Technology
eConsent
Advarra’s eConsent system is designed to enhance participant engagement while ensuring regulatory compliance through 21 CFR Part 11 standards. With interactive multimedia tools and real-time tracking, it simplifies the consent process for both participants and site staff. The system streamlines oversight, verifies comprehension, and supports remote workflows, making it an essential tool for modern research sites.
Key Features:
- 21 CFR Part 11 compliance
- Real-time progress tracking
- Remote consenting workflows
- Knowledge assessments verification
- eSignature compliance
Simplified and Compliant Consenting
Increased Compliance
Ensure 21 CFR Part 11 compliance with eSignatures and time-stamped documentation. Automatically notify staff when re-consenting is needed to maintain regulatory adherence.
Real-time Tracking
Track consenting progress and completion in real-time, providing instant updates on participant status. This helps streamline oversight and reduces time spent managing the process manually.
Streamline Site Workflow
Improve staff efficiency with remote access, real-time alerts, and status checks. Automate document handling, including signature prompts and initial requirements.
Participant Engagement
Keep participants involved with interactive multimedia, including text, video, and audio formats. Knowledge assessments verify comprehension, ensuring participants fully understand the consent process.
Remote Consenting
Enable remote consenting for participants and legally authorized representatives (LAR) who aren’t physically present. Support optional consents and customized workflows based on participant needs.
Secure Document Storage
Automatically email signed consent documents to participants and store them securely in the system. This ensures both compliance and easy access to critical documentation.
Advanced Customization
Advarra eConsent allows for highly customizable consent workflows tailored to each study’s needs. Clinicians can determine the required consent documents, decide whether a witness or legally authorized representative (LAR) is necessary, and add optional consent forms. This flexibility ensures the consenting process meets specific regulatory and participant requirements while providing a consistent and streamlined experience across various studies.
Ready to streamline your consenting process and ensure compliance?
