Please note that the IRB does not require investigators to submit case report forms (CRFs) to the IRB for review. CRFs are designed to be specific to study sponsors’ data collection and analysis needs, and when they are submitted, the IRB does not review them closely. Also, submitting a CRF with a new submission has the unintended effect of almost obligating you to submit any subsequent CRF revisions, which again is not a regulatory or policy requirement. On the rare occasion when the IRB needs to review a CRF for some reason, we will issue a contingency specifically requesting it.