World of Compliance Module

FAQ

1. What is meant by the term "recognized competence of investigators?"
   1. FDA regulations don't specifically state that an investigator must have a Ph.D. or be a pharmacist or doctor. In general, sponsors are responsible for selecting qualified investigators. It is very common, for example, for an ophthalmologist to do ophthalmology studies, or to have cardiologists doing cardiology studies. There isn't a prohibition against others doing those studies, but ultimately, it's the sponsor's responsibility. The respective FDA review divisions will evaluate clinical investigator qualifications, particularly if, for example, a podiatrist was doing an ophthalmology study.
2. FDA carries out inspections after the studies. Do FDA guidelines specify how long the data generated have to be kept on site?
   1. When it comes to a marketing application, FDA regulations require that data be kept for 2 years after the drug has been approved for the indication under which it's being studied. FDA regulations spell out the various timeframes. Of course, FDA can inspect an ongoing trial or study.