OpenClinica eConsent allows users to get 21 CFR Part 11-compliant signatures from participants and countersignatures from Investigators and CRCs through electronic means.
It also provides tools for tracking the consent status of participants and an audit trail of all informed consent activity. PDF copies of signed eConsent forms can also be downloaded by Participants as needed.
The eConsent module must be activated from the Modules page before any eConsent functionality is available.