FDA Regulations for Clinical Trials

Protection of public health is the main responsibility of the Food and Drug Administration. This is accomplished by enforcing numerous regulations regarding the operation of clinical trials on any product. Some of these regulations are taken from a set of guidelines for conducting clinical trials known as good clinical practices, or GCP.

Code of Federal Regulations

• Existing regulations set by the FDA covering all aspects of a clinical trial are classified under the code of federal regulations, or CFR. Operational procedures are outlined in each CFR for completing informed consent, obtaining signatures, financial procedures and completing the appropriate applications. Following the specifications set out in the applicable CFR will mean fewer violations during FDA inspections.

Bioresearch Monitoring

• Ensuring clinical trials are being conducted according to the regulations involves sending field monitors to sites where the studies are being done, known as the bioresearch monitoring program, BIMO. Inspections are done using compliance program guidance manuals that field personnel can use to guide the inspection process. These guidance manuals cover the examination of various clinical trial staff and operations including clinical investigators, sponsors, monitors and contract research organizations. Inspectors will verify that the rights, safety and welfare of subjects involved in a clinical trial are protected; clinical trial data is accurate and reliable; and the conduct of a clinical trial is in compliance with all other FDA regulations. All clinical trial staff are expected to put patient safety first, above all other aspects of the research.

Non-compliance

• Inspectors noticing that one or several of the FDA regulations have not been followed in a clinical trial will notify the FDA who will normally issue a warning letter. This allows the site some time to rectify the situation and come under compliance. In more severe instances when it has been found that a clinical trial investigator has violated regulations on a recurring basis, a letter known as a "notice of initiation of disqualification proceedings and opportunity to explain" will be issued. This lets the investigator know that the FDA is deciding whether or not to disqualify him from trial operations. The FDA will conduct a hearing with clinical trial personnel before presenting a final decision regarding a regulatory violation.