As noted in our previous blog,  in most cases when a monitor or CRO is brought into a clinical research study, the protocol, case report forms, and informed consent template have already been finalized.  Moreover, some or all investigative sites may have already received IRB approval of their protocol and informed consent document.  As noted in 21 CRF Part 812.42, the sponsor is required to have all study documents approved by the participating institution’s IRB.  The IRB, on the other hand, is required to review clinical research activities, as noted in 21 CFR 56.109.