eConsent

CRIO eConsent is an informed consent form (ICF) management tool built for clinical research sites. It is embedded directly within CRIO's eSource platform, meaning consent tracking and execution occur within the same workflow used for source data capture, without requiring coordinators to switch between separate systems.

Informed consent is a frequent source of protocol deviations, particularly when re-consents are missed as new ICF versions are approved. CRIO eConsent is designed to address this by automatically checking consent status at each patient visit and alerting coordinators when a patient has not signed the current version, supporting compliance with ICH, FDA, and IRB requirements.

Core ICF Management Capabilities

• Configure, execute, and track eConsent forms within the eSource workflow
• Automatically checks at each visit whether the patient has executed the most recent ICF version
• Notifies the clinical research coordinator if a patient has not consented under the current form
• Provides a direct link to open the associated eConsent or initiate a remote consent procedure
• Automatically tracks which patients have executed which ICF versions
• Completed eConsents flow automatically into Reviewer EDC, giving clinical research associates a single location to view subject source data and executed forms

Remote and Flexible Consenting

• Patients can review and sign consent forms from any location, without requiring an in-office visit
• Consent forms are accessible across devices, including smartphones
• Patients can complete the consent process outside of standard clinic hours
• System-generated PIN codes are used to verify patient identity during remote consent
• Coordinators can send, review, and countersign consent forms electronically within a single platform
• Removes the need for dedicated pre-consent appointments, which can run approximately 1.5 hours

Version Control and Compliance

• Ensures patients always sign the latest IRB-approved consent form
• Eliminates the need for manual tracking of ICF versions
• Reduces the risk of missed re-consent protocol deviations
• Supports protocol adherence while reducing administrative burden on site staff

Reported Outcomes

• Innovo Research used CRIO eConsent and reported a 200% increase in patient enrollment in a cancer screening study
• Cited benefits included reduced patient burden and the ability to conduct after-hours consent

CRIO eConsent integrates with CRIO's broader suite of site solutions, including eSource and eRegulatory tools. Executed consent forms are accessible through Reviewer EDC for remote monitoring, supporting centralized oversight of subject records and consent documentation.