eConsent

RealTime eConsent is a 21 CFR Part 11 compliant electronic consent solution designed to help clinical research sites enroll participants faster and more efficiently. By enabling remote consenting through RealTime's Participant Portal, MyStudyManager™, the platform allows subjects to review and sign consent documents conveniently via desktop or mobile app, supporting both traditional and decentralized clinical trials (DCTs).

eConsent is fully integrated with RealTime's Site Operation Management System (SOMS), providing a seamless end-to-end workflow that reduces administrative burden, minimizes errors, and helps sites maintain regulatory compliance throughout the consent process.

Key Features and Capabilities

• Remote consenting via desktop and mobile app — participants can consent anytime, anywhere, accelerating study enrollment and supporting decentralized clinical trial models.
• 21 CFR Part 11 compliance — the platform is built to meet FDA regulatory requirements for electronic records and signatures.
• Elimination of missing consent deviations — directly addresses one of the FDA's most common 483 findings by ensuring consent documentation is complete and properly managed.
• Automated eConsent routing — consent forms are automatically routed based on language, version, and other configurable criteria, saving time and reducing manual effort.
• Version control — ensures that study staff and participants are always working with the most current version of a consent document.
• Signature order management — administrators can manage the order of signees and customize the placement of elements such as signatures, date/time stamps, and checkboxes using RealTime's proprietary Sign on the Line technology.
• Consent status monitoring — quickly review the status of pending or completed signatures on each individual consent form.
• Staff training and delegation oversight — ensures that study staff are properly trained and delegated to perform consent responsibilities before participating in the process.

Workflow Benefits

• Streamlines the enrollment process through mobile and desktop remote consenting capabilities.
• Reduces errors and saves time with automated routing and signature management.
• Provides centralized consent oversight across all active consent forms and participants.
• Supports decentralized clinical trials by removing geographic barriers to participant consent.

As part of RealTime's broader Site Operation Management System (SOMS), eConsent integrates seamlessly with other clinical site management tools, providing a unified platform for managing site operations, compliance, and participant engagement from a single system.