The Bioresearch Monitoring Unit of the FDA may conduct inspections of medical research and testing facilities in order to ensure studies avoid bias and follow proper testing procedures. The FDA inspector will review all case study data and may interview subjects and doctors. In all types of inspections, an FDA inspector checks the study for errors that affect the outcome. Investigators may expect the following types of inspections:
- Routine Inspection may be conducted at random. It is sometimes triggered by abnormally high enrollment rate as well as large studies to promote a pivotal drug.
- For Cause Inspections: FDA investigator has a reason to check out a research facility, i.e., subject complaint, a highly publicized drug, unqualified investigators, large AE clustering.
Once you receive notification of the FDA audit notify the appropriate research administration offices, including the IRB. Specific procedures to follow when preparing for an inspection and on the day of the inspection will be discussed with the research team prior to the inspection date.
FDA Guidance: FDA Inspections of Clinical Investigators