FDA Guide to Inspection

Physicians or scientists testing a food, product or medical device for use in humans are conducting clinical studies. They are known as "clinical investigators." The Food and Drug Administration (FDA) Bioresearch Monitoring Program routinely inspects clinical investigators' work to ensure validity of the research study and to protect people who later may use those products.

Routine Inspections

• FDA field offices conduct routine inspections of clinical investigators to validate studies important to the approval of therapeutic drugs, products or devices. High priority is placed on clinical studies critical to applications for approval of new drugs. There are two parts to the investigation. The investigator first evaluates the qualifications of study personnel, the physical location of the study, how study data is recorded and stored and accountability for the drug or product. Then the investigator audits the data by comparing the original information submitted to the FDA with the supporting data, including all available records from before, during and after the study. The FDA investigator conducts an exit interview with the clinical investigator to discuss findings, clear up any ambiguities and provide a written statement of observations made during the inspection. The FDA investigator submits a written report to headquarters. The clinical investigator then receives one of three types of letters from the FDA: a thank you letter (no significant deviations or violations were found); an information letter that identifies deviations from regulations and good investigational practices; or a Notice of Significant Findings of deviations and deficiencies. This letter could result in a "for cause" inspection.

For Cause Inspections

• "For cause" inspection is an extension of a routine inspection. The FDA investigator goes into greater depth to audit the study data and records. For cause inspections can be done for reasons including involvement in a large number of investigational studies; clinical investigators doing work outside their specialty; inconsistent or suspicious findings or results compared with similar studies; or difficulty obtaining documents from the investigator.

  If the findings are serious deviations and violations of FDA regulations or fraud, then the FDA will initiate actions to restrict or disqualify the clinical investigator from future studies and place him on a blacklist.

Clinical Investigators Blacklist

• The FDA maintains a list of clinical investigators who are restricted or disqualified from conducting clinical studies because they have violated FDA regulations or been involved in fraud. It is always good to periodically check this list before participating in any clinical research study. You can find this list on the FDA website (see Resources).