eConsent

Clinion eConsent is an electronic informed consent platform designed for clinical trials. It replaces traditional paper-based consent processes with a digital workflow that supports faster patient enrollment, real-time oversight, and regulatory compliance. The platform is available in three deployment models: Site eConsent, Remote eConsent (virtual consent), and eConsent bundled with ePRO, giving sponsors and sites flexibility to match their study design and patient population.

The platform is suited for interventional, observational, decentralized, and hybrid trials, and supports both global and localized implementations. It integrates directly with Clinion's EDC system and connects with other clinical trial solutions including RTSM, eProtocol, eSource, CTMS, CSR Automation, and eTMF.

Deployment Models and Access

• Site eConsent: participants access consent forms on site-provided devices such as tablets and iPads
• Remote eConsent: participants access the digital consent form on their own devices from any location
• eConsent bundled with ePRO: includes teleconsultation capability, allowing the principal investigator to engage with the patient remotely during the consent process

Consent Workflow Steps

1. Participant reviews the eConsent form on a site device or their own device
2. Participant reads the form, asks questions, and digitally signs; remote or ePRO-bundled deployments support PI teleconsultation
3. Investigators review and approve consents, eliminating paperwork delays
4. Subjects are automatically enrolled into the EDC system with real-time dashboard visibility
5. Time-stamped signatures, ICF version control, and compliance tracking are maintained automatically throughout

Key Features

• Multimedia-driven consent forms with embedded videos, visual aids, and FAQs to support participant comprehension
• Embedded questions and live support within the consent interface
• Automated delivery of digitally signed eConsent forms for secure record-keeping
• ICF version control with automatic tracking of consent versions
• Automated re-consent workflows triggered by protocol amendments, with participant notifications and real-time investigator monitoring
• Multilingual support for global trial populations
• Compatibility across iOS, Android, and tablet platforms
• Real-time data sync and subject enrollment integration with Clinion EDC

Compliance and Audit Readiness

• Audit trails with time-stamped signatures and complete action logs
• ICF version history management
• Designed to meet FDA and GCP guidelines
• Compliant with HIPAA, GDPR, and 21 CFR Part 11
• End-to-end encryption and role-based access controls for participant data security
• Detailed access logs for full traceability

Responsible AI Principles

• Accountability
• Transparency
• Privacy and Security
• Reliability and Safety
• Fairness

Clinion eConsent is part of Clinion's broader integrated clinical trial platform. It connects with the full suite of Clinion solutions and is built to support audit-ready, compliant trial operations across diverse study types and geographies.