Miami CTSI

REDCap E-Consent Framework for FDA Regulated Studies

11.02.2021

A joint announcement from the Miami CTSI and the Office of the Vice Provost for Research and Scholarship

We are excited to announce that we now have a REDCap e-consent Framework that is 21 CFR Part 11 compliant. You can use this new REDCap e-consent Framework to obtain electronic consent from research participants enrolling in FDA regulated studies. FDA-regulated studies investigate a drug, medical device or biologic.

With this new e-consent Framework, there are now two REDCap e-Consent Templates:

  1. The CTSI e-Consent template for use with non-FDA regulated studies; and
  2. The 21 CFR Part 11 e-Consent Template for use with FDA-regulated studies.

You can find the new template in REDCAP under the Choose a project template section under the New Project view – please see screenshot below.

Process to request access to the 21 CFR Part 11 e-Consent Template

Before submitting a request to access the 21 CFR Part 11 e-Consent Template, all study team members who are involved in the consent process must complete the 21 CFR Part 11: REDCap e-consent Workflow training. The 21 CFR Part 11 e-Consent Template meets the FDA’s requirements for electronic signatures, so you must use this consent template when you obtain electronic consent from research participants for FDA regulated studies. The REDCap system administrator will verify proof of training for all study team members before approving your project request.

How does the 21 CFR Part 11 e-Consent Template differentiate from the CTSI e-Consent Template?

The 21 CFR Part 11 e-Consent Template is only for FDA regulated studies. The CTSI e-Consent Template is available to obtain electronic consent for studies that are not FDA-Regulated. The CTSI template is also available under REDCap’s Choose a Project template section under the New Project view.

How to access the e-Consent trainings?

  1. Visit https://www.e-gcrme.com/ctsi/
  2. If you haven’t done so, register for an account with your University of Miami email address.
  3. Select the e-Consent course you want and click on “enroll me” to add it. This will allow you to view the video and materials. Direct course links are here:
    CTSI e-Consent Template for non-FDA regulated studies
    21 CFR Part 11 for FDA regulated studies

You will be able to download a training certificate upon training completion to store for your records. When you submit your research project request to use either of these e-Consent templates, you will be asked if you and the members on your team who will obtain electronic consent have completed this required training. You only need to complete the training for the e-Consent option that you plan to use – you do not need to complete the 21 CFR Part 11: REDCap e-Consent Workflow training to use the CTSI e-Consent Template. Likewise, you also do not need to complete the CTSI e-Consent training to use the 21 CFR Part 11 e-Consent Template.

Questions & Feedback

For any questions, please email redcapadmin@med.miami.edu. We also welcome your feedback on your use and experience with the new 21 CFR Part 11 e-Consent Template.

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