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Onboarding

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.
Built forSubjectInvestigatorCRC
Onboarding
  • Capabilities

What you get

  • 01
  • 21 CFR Part 11 compliant e-signatures
  • 02
  • Multi-language consent forms
  • 03
  • Re-consent & full version tracking
  • 04
  • Comprehension quizzes before signing
  • 05
  • Time-stamped audit trail for every action

See eConsent live

Book a tailored walkthrough and we'll show econsent configured around your protocol.

  • One hybrid platform
SubjectInvestigatorCRC
Request a demo
  • One hybrid platform
eConsent removes the biggest source of protocol deviations at most sites — incomplete or outdated paper consent.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.
  • One hybrid platform

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.
  • How it works

From setup to outcome

  • 01

Author & approve

PI/CRC create the ICF, add explainer videos and FAQs, and lock the approved version on the web console

  • 02

Assign to subjects

The correct consent version is pushed to each subject's mobile app, in their preferred language.

  • 03

Review & sign

Subjects read, complete comprehension checks, and apply a compliant e-signature from any device.

  • 04

Track & re-consent

Sites monitor completion and the platform auto-pushes re-consent whenever the protocol changes.

  • FAQ

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.
When a new ICF version is approved, re-consent is pushed automatically and each subject’s status is tracked until completed.
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.

More in Onboarding

eEnrolment

Streamlined subject enrolment from screening to randomisation, all from a single guided workflow.

Learn more

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