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The printed name of the signer.
The date and time of when the signature was executed.
Note: Time of signature will be tracked within REDCap logging and does not need to be recorded on the form itself.
The meaning (review, approval, responsibility, authorship, etc) associated with the signature.
Note: This requirement is covered by the certification of the signature by the participant, as well as the signature of the coordinator on the attestation.
How to Implement
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Electronic Consent in REDCap
Researchers must follow procedures to meet compliance as outlined in the eConsent REDCap Template project template. Fields and forms may be ammended based on study requirements. For FDA regulated studies, this template the e-consent and attestation instruments should be used as is.
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Note: Only one signature may be captured for each e-consent instrument. |
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Gathering Particpant Contact InfoInitial participant contact information should be collected by study personnel and entered into the Participant Contact Info instrument. This instrument will collect the date, participant’s name, email, DOB, and preferred language, consent type, age group, and a field that will trigger the e-Consent form to be sent electronically.  |
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e-Consent InstrumentsElectronic consent instruments MUST be enabled as surveys, with Auto-Archiver + e-Consent Framework enabled in the survey settings for the instrument. The ability to edit responses MUST be left unchecked. Enter the version number in the e-Consent version field, and you may optionally add the type in the e-Consent type field.   The consent date field has a minimum and maximum validation set to ‘today’.  |
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