The University of Iowa

FDA Inspection of a Clinical Investigator

What if the FDA contacts me and wants to conduct an inspection?

Guidance is available on the FDA's website about such inspections. Here you will find details about the types of inspections and what your expected role will be. An inspection is not necessarily initiated because of any problem with the investigator; sometimes it may be initiated because an investigator conducted a pivotal study that merits in-depth examination due to its singular importance in product approval or its effect on medical practice."