Electronic Informed Consent
Multimedia-rich digital consent with comprehension verification, remote signing, and complete ICH E6(R3) GCP compliance.
Consent That Patients Actually Understand
Transform informed consent from a legal hurdle into a genuine patient education experience.
Multimedia Consent Documents
Enrich consent forms with embedded videos, interactive diagrams, and expandable glossary terms. Patients engage with content rather than scrolling through dense legal text.
Comprehension Checks
Configurable knowledge assessments embedded within the consent flow. Verify understanding of key concepts like risks, alternatives, and withdrawal rights before signature.
Remote & Hybrid Consent
Patients can review and sign consent documents from home via secure web link or mobile app. Support for witness cosigning and legally authorized representative workflows.
Version Control & Re-Consent
Automated reconsent workflows when protocol amendments change the informed consent document. Track which version each participant signed and manage transitions seamlessly.
Multi Language Support
Manage translated consent documents with side by side editing and certification tracking. Ensure regulatory-compliant translations across all study languages.
eSignature & Audit Trail
21 CFR Part 11 compliant electronic signatures with timestamp, IP address, and identity verification. Complete audit trail from first view to final signature.
ICH E6(R3) Compliance
Purpose built for the latest ICH E6(R3) guidelines emphasizing participant centric, technology enabled consent processes with proportionate risk based approaches.
How It Works
From document creation to signed consent in three steps.
Create Consent Documents
Build multimedia consent forms with the visual editor. Add videos, interactive elements, and comprehension checks, then generate multi-language versions.
Deliver & Educate
Send consent documents to patients remotely or present on site. Track engagement metrics, comprehension scores, and time to signature for every participant.
Sign & Manage
Capture legally binding eSignatures with full identity verification. Manage reconsent workflows automatically when protocol amendments occur.
See it in action
eConsent, eCRO & eSurvey — One Place
Ready to Modernize Your Clinical Trials?
Join leading sponsors, CROs, and research sites using Vitruvian Shield to run faster, smarter, and more compliant trials.
Or contact our team for a personalized walkthrough.