Page Comparison

REDCap eConsent: Contactless Consent

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• A public link: Can be broadly distributed
• Individualized Survey Links: Sent to specific individual

(See Survey Distribution &/or e-Consent Knowledge Articles)

On the Online Designer page, set up the Survey Notifications so that the survey coordinator is notified when the participant's consent document is completed.

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Additional Considerations

• For studies requiring Part 11 Compliance, the Attestation instrument should be enabled as a survey with the e-Consent framework and signature clearing functionality enabled. This is enabled under Survey Settings in the e-consent framework section
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• If amendments are made to the original IRB, should the current e-Consent be updated and a version number used? Or should a new e-consent instrument be created for each IRB amendment?
  • There are several ways to incorporate e-Consent design changes in your project. The best method is dependent upon what is dictated by your PI, IRB, project reporting needs and the project design itself.
    • If your consent is text incorporated in a Section Heading with a simple Yes/No question agreeing to the consent and you plan to use the PDFs in the File Repository to track versions, then adding a version number within the Survey Setting eConsent parameters would be adequate.
    • If your consent contains a number of qualifying / conditional questions and you plan to make broad changes, you may want to add an additional eConsent instrument. This will allow you to use REDCap reporting functionality
    • A third option is to use the HiddenSurvey action tag functionality in combination with econsent version numbers. You can leave the original questions, hide them with the Action Tag, and then add new econsnet questions for future participants.

• Should I enable Force Signature in my e-consent settings:
  • "Use of the Force signature fields to be erased" is clinical best practices and is standard for Part 11 compliance.

• Should I use the e-consent type field?

The e-Consent Type field is an optional free form text "label" field that can provide clarification or additional information on the PDF. It (along with the optional Date of Birth) is printed on the bottom of the PDF form. The label can be used to identify gender, patient type, or anything you want it to be to segregate participants. i.e., Adult / Pediatric or Male / Female / Other or Ambulatory / Inpatient. Anything! Merely a label.

• Which is best to use in a study: type in a name or using the 'signature' field?

Clinical best practice would be to include both a printed legible name and a signature field for the participant e-consent and attestation forms