eConsent

About e-Consent (Electronic Consent)

Electronic Consent (e-Consent) simplifies and enhances the informed consent process in clinical trials. With the AnzuBridge® e-Consent Builder, research teams can customize informed consent documents to meet the specific requirements of each study, providing a streamlined and efficient onboarding experience for participants. e-Consent allows for complete configuration of signatory workflows, including role-based electronic signatures, enabling seamless consent collection from subjects, guardians, or legal representatives.

The system empowers study participants by providing a clearer understanding of the trial they are participating in, incorporating multimedia elements and knowledge checks directly into the consent process. These features help to ensure participants fully grasp the study details before providing their consent, ultimately improving patient engagement and compliance.

e-Consent’s Knowledge Checks take participant understanding to the next level. With the AnzuBridge® e-Consent Builder, you can add introductory videos, supplemental content, and post-review questions to validate that participants have reviewed and comprehended the consent document. Knowledge Checks can be designed with a range of media—text, images, audio files, and even video—to ensure the content is accessible and clear. The platform also allows participants to review the consent document, complete the Knowledge Checks, and provide their e-signature—all from a single screen.

With e-Consent, researchers can create customized workflows that are tailored to the needs of both the site and the participants, including signatory triggers for subject screening and updates to consent documents delivered in real-time across different study sites. The platform also allows for version control, ensuring that all subjects and sites have access to the latest informed consent forms.

In addition to simplifying the administrative process, e-Consent offers enhanced security, protecting sensitive patient data through secure digital signatures and regulated storage. This compliance ensures that the consent process meets the strict requirements set by regulatory agencies, including the FDA’s guidance on electronic informed consent in clinical trials. By leveraging e-Consent, clinical trials can enhance the consent process, improve participant understanding, and increase efficiency across the board.