eConsent
Replace paper consent with a guided, fully auditable electronic informed consent flow. Subjects review study information at their own pace, confirm understanding with built-in comprehension checks, and sign securely from any device. Every action is captured in a tamper-evident audit trail.
What you get
eConsent removes the biggest source of protocol deviations at most sites — incomplete or outdated paper consent. The PI and CRC author each ICF version once on the desktop console, attach explainer media, and publish it to the right cohorts. Subjects then complete consent on their own device, on-site on a tablet or remotely from home, while the platform enforces that the current approved version is always the one being signed. When the protocol changes, re-consent is pushed automatically and every subject's status is tracked until closed.
Onboarding
eConsent
Purpose-built for hybrid & decentralized trials — one workflow across desktop and mobile.
Desktop for study teams, mobile for subjects
eConsent works across the ProCTTH hybrid platform — site staff (CRC, PI, CRA) work on the desktop web console, while subjects access the study from the mobile app.
Desktop console
CRC · PI · CRA
PI and CRC build ICF versions, attach media, assign forms to cohorts, monitor signature status in real time, and trigger re-consent. CRAs review the complete consent audit trail remotely during monitoring.
Mobile app
Subject
Subjects open the study app, read the consent at their own pace in their language, complete comprehension checks, and sign with a compliant e-signature — on-site or from home.
From setup to outcome
Author & approve
PI/CRC create the ICF, add explainer videos and FAQs, and lock the approved version on the web console.
Assign to subjects
The correct consent version is pushed to each subject's mobile app, in their preferred language.
Review & sign
Subjects read, complete comprehension checks, and apply a compliant e-signature from any device.
Track & re-consent
Sites monitor completion and the platform auto-pushes re-consent whenever the protocol changes.
Common questions
Is the e-signature compliant?
Yes. eConsent meets 21 CFR Part 11 and equivalent regional requirements, with a tamper-evident, time-stamped audit trail for every action.
Can subjects consent remotely?
Subjects can consent on-site on a site tablet or fully remotely from their own phone — the workflow is identical either way.
How are protocol changes handled?
When a new ICF version is approved, re-consent is pushed automatically and each subject's status is tracked until completed.