FDA will ensure that the sponsor has a process of identifying and dealing with protocol deviations in real time during the conduct of a clinical trial. The inspection will review monitoring procedures and the amount and type of clinical data that is reviewed during monitoring visits. Most importantly, FDA will assess the sponsor’s procedures for dealing with non-compliant sites and what escalation process is in place to assure that non-compliant site are not allowed to continue the study. FDA will also assess if the sponsor has an effective process for capturing protocol deviations for inclusion and evaluation in the clinical trial report.
