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Digital Signature Requirements

In order to comply with digital signature requirements for electronic consent, researchers must ensure of the following:

  • The identity of the participant signing has been verified.

  • Electronic signatures will be unique to each participant and shall not be reused or reassigned to anyone else.

  • Electronic signatures will be certified by the participant that they are intended to be the legally binding equivalent of handwritten signatures prior to signing. 

  • Additional certification or testimony that electronic signatures are the legally binding equivalent of handwritten signatures obtained before submission. 

Signed electronic records must include:

  • 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 Digital Signatures in REDCap

Researchers must use the eConsent REDCap Template for CFR Part 11 Validated Project project template. Fields and forms may be adjusted or removed, based on whether the project is for an FDA regulated study, includes participants under the age of 18, etc.

Gathering Particpant Contact Info

Initial 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.

Adult e-Consent in ICF Instrument

Electronic 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. 

The consent date field has a minimum and maximum validation set to ‘today’.

The e-Consent link will be sent through an Autmated Survey Invitation to the email given depending on conditional logic provided in the Participant Contact Info instrument.

When the participant opens the link provided to them, they will see the form below.

On the next page, the participant reviews their consent document, and they will check the box certifying their electronic signature.

Assent and Parental Permission Surveys

For participants aged 7 to 17, an assent survey is needed. This requires the same information as the example above - participants name, date of birth, signature, and date of signature.

When participants are under the age of 18, a parent must also sign a parental permission survey. In the case where participants are under 7 years old, only the parental permission survey is needed. This survey does not require the participant's signature, but requires the participant's name, date of birth, parent(s)/guardian(s) name(s), parent(s)/guardian(s) signature(s), and date signed.

INSERT IMAGE OF PPF

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