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.
How to Implement Digital Signatures in REDCap
Researchers must use the CTSI e-Consent ? instrument template found in the REDCap CTSI FDA e-Consent and EDC ? project template. Fields may be adjusted as needed, pending REDCap admin approval.
Electronic consent instruments MUST be enabled as a survey, with Auto-Archiver + e-Consent Framework enabled in the survey settings for the instrument. The ability to edit responses MUST be unchecked.
Signed electronic records must include:
The printed name of the signer.
The date and time of when the signature was executed.
Note: The date field must be validated with the minimum and maximum values "today". 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.
Once the participant signs the consent survey, they will check the box certifying their electronic signature.
For more detailed instructions on how to implement e-consent in REDCap, see the e-Consent Knowledge Article.
Assent and Parental Permission Forms
For participants aged 7 to 17, an assent form 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 form. In the case where participants are under 7 years old, only the parental permission form is needed. This form does not require the participant's signature, but requires the participant's name, date of birth, parent's name, parent's signature, and date signed.
Typical e-Consent Framework Flow
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