e-Consent

FEATURES

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Customize your Informed Consent documents using the Anzubridge® e-Consent Builder
  • Upload your Informed Consent document
  • Configure your signatory workflow based on the study requirements
    • Customize signatory workflows for subject onboarding
    • Create signatory “triggers” for subject screening
  • Configure primary signatory preferences (subject and/or legal guardians) based on participant requirements and site requirements
  • Identify role-based electronic signature (locations) in the informed consent document
  • Provide your study subjects a better understanding of the informed consent and the study, by adding multi-media and knowledge checks to your document.
    • Unique informed consent document viewer for study participants to engage in the knowledge check process
Customize your Informed Consent documents using the Anzubridge® e-Consent Builder
  • Upload your Informed Consent document
  • Configure your signatory workflow based on the study requirements
    • Customize signatory workflows for subject onboarding
    • Create signatory “triggers” for subject screening
  • Configure primary signatory preferences (subject and/or legal guardians) based on participant requirements and site requirements
  • Identify role-based electronic signature (locations) in the informed consent document
  • Provide your study subjects a better understanding of the informed consent and the study, by adding multi-media and knowledge checks to your document.
    • Unique informed consent document viewer for study participants to engage in the knowledge check process
Deliver updated versions of the informed consent to all subjects

Create and deliver customized versions of the informed consent documents to different sites

 

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21CFR Part 11 Compliant

Q&As
The FDA does not require the use of electronic informed consents (e-Consent) with knowledge checks for all clinical trials. However, the FDA recognizes the benefits of using e-Consent, including increased patient engagement and understanding of the trial, and improved accuracy and efficiency of the consent process.
The FDA has issued guidance documents on the use of e-Consent in clinical trials, which outline the requirements and considerations for implementing e-Consent in trials. The guidance encourages the use of e-Consent with knowledge checks as a way to enhance patient understanding and engagement in the consent process.
While the use of e-Consent is not required by the FDA, it is important for companies to consider its use in clinical trials, particularly as technology advances and patient expectations for electronic engagement continue to evolve. Additionally, the use of e-Consent may be required by specific regulatory agencies in certain countries, so it’s important to review local regulations and requirements.
The source document for FDA guidance on electronic informed consents with knowledge checks is the “Guidance for Industry: Use of Electronic Informed Consent in Clinical Investigations.”
This guidance document provides recommendations for the use of electronic informed consent in clinical trials, including the use of knowledge checks to ensure that subjects understand the information presented in the informed consent process. The guidance outlines the importance of using clear and concise language in electronic informed consents, as well as the need for secure and regulated storage of these data.