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Part 11 E-Consent

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The e-consent module in REDCap is now validated for use in studies requiring FDA 21 CFR Part 11 Compliance.

If you are already familiar with setting up e-consent forms for CHOP studies, please be advised that there are many settings required that are specific to Part 11 studies and may differ from your previous experience setting up REDCap e-consent forms.

Please complete the Part 11 Consent Training and Attestation before starting to work on your e-consent forms.

At CHOP, only REDCap’s e-Consent module is validated to be Part 11 compliant. REDCap is not Part 11 validated for electronic data capture.