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Researchers must follow procedures to meet compliance as outlined in the eConsent REDCap Template for CFR Part 11 Validated Project 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
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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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Sending e-Consent
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.
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When the participant opens the link provided to them, they will see the form a form similar to the one shown below.
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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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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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Version Control
When informed consent documents are updated, it is important to track new versions. In the File Repository in the PDF Survey Archive folder, you will see all signed e-Consent documents and their versions (and optionally entered types).
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Copy the consent instrument, and rename it with the version number appended and suffix _v2 added to variables.   In the survey settings, make sure to edit the e-consent Framework fields to the new v2 variables. In the Optional fields, you can enter the type (i.e. Adult, Assent, Parental Permission Form). Make sure to save your changes.  Add Make sure to inactivate old Automated Survey Invitations (ASIs), modify Alerts, or modify the Survey Queue depending on your distribution method.   It may be beneficial to add form display logic for your new consent instruments. In this example, if v1 is being used up to 12/10/2022, I will update the logic for both instruments to follow that.  Finally, inactivate the old version(s) of the consent survey by turning the status to “Survey Offline” in the survey settings.  |
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