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To make an informed decision about whether to participate or not in a clinical trial, participants need to be informed about:
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A central part of the informed consent process is the attestation document. The University of Utah IRB requirements for informed consent are met by using the eConsent survey(s) and Attestation data entry instrument in the eConsent REDCap Template for CFR Part 11 Validated Project. The purpose of the attestation instrument is to document that the research team has given the participant every opportunity to understand and make an informed decision before signing the consent document, and verify the individual who is attesting the participant’s signature.
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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