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Operational aspects of informed consent can be captured in REDCap to meet part 11 compliance. For more information, see U of U policies or the FDA website.
Documentation of Informed Consent
All fields and requirements for IRB documentation of informed consent can be tracked in the Documentation of Informed Consent report in the eConsent REDCap Template for CFR Part 11 Validated Project.
Fields in the report may be ammended based on study requirements, but you must include the participant’s name, IRB approval date, date and version for each consent instrument, attestation date, and the study team representative’s name that filled out the attestation form.
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