Digital Signature Requirements
In order to comply with digital signature requirements for electronic consent, researchers must ensure of the following:
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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 Digital Signatures 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 should be used as is.
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.
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e-Consent Instruments
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. Enter the version number in the e-Consent version field, and you may optionally add the type in the e-Consent type field.
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The consent date field has a minimum and maximum validation set to ‘today’.
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Using e-Consent
e-Consent surveys can be sent through Automated Survey Invitations (ASI) or opened as a survey in the REDCap project by a coordinator and handed over to the participant.
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On the next page, the participant reviews their consent document, and they will check the box certifying their electronic signature.
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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.
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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.
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Additional Electronic Consent
There are instruments included in the template for situations where legally authorized representative (LAR), witness, and/or interpreter consent documents are needed.
File Repository
To view PDFs of locked records, signed e-consent surveys, and other uploaded files, navigate to the "File Repository" under Applications in the left navigation bar.
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You will see a list of signed e-consent surveys.
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Version Control
When informed consent documents are updated, it is important to track new versions. To update consent documents in a project, enter DRAFT mode and follow 1 of 2 options:
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