FDA Inspection of Clinical Research Sponsors and Investigators: Avoiding the Pitfalls

Abstract

The United States Food and Drug Administration (FDA) conducts more than 200 inspections of clinical sponsors and investigators each year. The sponsors, monitors, and investigators of every important trial submitted to the FDA in support of a new drug application (NDA) for premarket approval may be inspected. FDA inspections are mostly routine—89% involve no further follow-up by the FDA. However, failed inspections can result in disqualification of the investigator, disqualification of the data, or termination of the investigational new drug exemption (IND) that gives the sponsor the right to conduct the experiments. Moreover, common faults of researchers, such as careless recordkeeping, can cause failure. Generally, the FDA is unlikely to impose extreme sanctions unless adequate case histories of patients are unavailable, records are falsified, or human subjects are put at peril. A sponsor or investigator can be protected during an FDA inspection by knowing a few common sense guidelines that are described in the article.