Frequently, by the time a monitor or CRO is brought into a clinical research study, the protocol, case report forms, and informed consent template have been finalized.  As noted in 21 CRF Part 812.42, the sponsor is required to have all study documents approved by the participating institution’s IRB.  As the sponsor is working to create their informed consent document, they likely reference 21 CFR Part 50, specifically incorporating all of the required elements of informed consent into their template.