...
A central part of the informed consent process is the informed consent document. The FDA does not dictate the specific language required for the informed consent document, but does require certain basic elements of consent be includedattestation 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.
...
| Expand | ||
|---|---|---|
| ||
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 added.  Finally, add form display logic for your 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.  |
...