Full course description
The U.S. Food and Drug Administration (FDA) conducts inspections to ensure the rights, safety, and welfare of subjects involved in FDA-regulated clinical trials are protected, to determine the accuracy and reliability of clinical trial data, and to determine if the study has been conducted in compliance with FDA regulations. The most common type of inspection is classified by the FDA as a “Routine” inspection and is generally triggered by a marketing approval submission. Clinical sites with the highest enrollment numbers in the pivotal trials are the most likely candidates for a routine inspection. “For Cause” inspections are less common, and generally are conducted to investigate a specific problem that has come to FDA’s attention.
The Office for Human Research Protections (OHRP) within the U.S. Department of Health and Human Services may also initiate and conduct inspections of clinical trials. The responsibilities, notification, conduct and response to OHRP inspections should follow the same procedures and requirements in this SOP, as applicable. The purpose of this SOP is to outline the processes for the preparation, conduct, and response to an FDA inspection of a clinical trial at the University of Utah.