eConsent

OpenClinica eConsent is a next-generation electronic informed consent solution designed to make the clinical trial consent process more engaging, comprehensible, and fully compliant. Built for academic researchers, sponsors, CROs, sites, and study coordinators, it replaces paper-based workflows with media-rich digital experiences that work on any device—without requiring participants to download an app or involve IT support.

Whether running decentralized, hybrid, remote, or in-person trials, eConsent integrates directly with OpenClinica EDC to give study teams real-time visibility into consent status, automated re-consenting workflows, and a complete audit trail—all within a single connected platform trusted by more than 1,500 sponsors, CROs, and research sites worldwide.

Who eConsent Is For

• Academic Researchers: Simplify IRB compliance and improve participant comprehension without adding complexity to existing workflows.
• Sponsors & CROs: Streamline consent across decentralized, hybrid, and in-person trials with automated re-consenting workflows that keep studies on track.
• Sites & Coordinators: Eliminate paper bottlenecks, reduce time spent chasing signatures, and monitor consent status in real-time directly inside the study platform.

Key Benefits

• Better engagement from the start: Use images, audio, and video to explain complex concepts clearly. Participants can review content at their own pace and in their own language.
• Verified comprehension: Embedded questions confirm participant understanding before signing, reducing protocol deviations and improving overall data quality.
• Zero friction for participants: Nothing to download or install. The solution works on any device participants already own, and automated reminders keep the process moving.
• Built for real-world trials: Purpose-built for decentralized, remote, in-person, and hybrid settings, with support for single or multiple signatures, multilingual populations, and automated Legally Authorized Representative (LAR) workflows.
• Direct EDC integration: Consent status is visible in real-time inside OpenClinica EDC, eliminating the need to log in and out of separate systems or search for documents manually.
• Automated re-consenting: When protocols change, re-consenting workflows trigger automatically, keeping studies compliant without manual tracking.

How eConsent Works

1. Create engaging consent forms: Build media-rich electronic Informed Consent Forms (eICFs) incorporating images, audio, and video, and add comprehension checks to verify understanding before participants sign.
2. Deploy anywhere, anytime: Share a secure link so participants can review and sign on any device—in the clinic, at home, or on the go—with no app required.
3. Track status in real-time: Monitor exactly where each participant is in the consent process directly within the study platform.
4. Stay compliant as protocols evolve: When amendments occur, automated re-consenting workflows trigger instantly, and participants automatically receive signed digital copies of their consent forms.

Features

• Media-rich consent forms supporting images, audio, and video
• Embedded comprehension checks
• Device-agnostic access with nothing to download or install
• Multilingual support for global studies
• Automated notifications and reminders
• Single or multiple e-signature capability
• Real-time consent status visibility
• Automated re-consenting workflows for protocol amendments
• Full integration with OpenClinica EDC
• Automatic delivery of signed digital copies to participants
• Complete audit trail compliant with 21 CFR Part 11
• HIPAA and GDPR compliant
• ISO 27001 and SOC 2 certified
• Transparent, modular pricing that fits study volume

Ideal Use Cases

• Decentralized and hybrid clinical trials
• Remote and in-person enrollment scenarios
• Global studies with multilingual participant populations
• Studies with frequent protocol amendments
• Trials requiring multiple signatures
• Teams seeking improved participant comprehension and engagement
• Studies requiring HIPAA and GDPR compliance

eConsent is delivered as part of the broader OpenClinica eClinical platform, which also includes EDC, eCOA, Randomization, EHR-to-EDC, and Reporting & Analytics capabilities. Its compliance certifications—including 21 CFR Part 11, HIPAA, GDPR, ISO 27001, and SOC 2—make it suitable for regulated clinical research environments across academic institutions, pharmaceutical and biotech companies, CROs, and research sites globally.