An FDA clinical trial audit need not be feared, so long as there is compliance with regulatory requirements.
The U.S. Food and Drug Administration (FDA) has been carrying out clinical trial auditing under its Bioresearch Monitoring (BIMO) Program since 1963, when the Investigational New Drug (IND) regulations came into effect. From then till now, the fundamental aim of an FDA clinical trial audit is to ensure that Institutional Review Boards (IRB's) submit clinical trial data to the FDA that is backed by required records, and that the trials are in compliance with the appropriate FDA regulations.
It has to be noted that the FDA clinical trial auditing requirements are not legally enforceable. They are only a set of recommendations that are derived from the FDA's understanding and thinking of the current situation.
Once an FDA clinical investigator lands at the study site, he/she will display his/her FDA credentials. The first task for the inspector of an FDA clinical trial audit is the issuance of a completed Form FDA 482 (Notice of Inspection), which will be given to either the clinical investigator or any other designated person. The FDA has the authority for accessing, inspecting, and copying any records that it thinks are necessary or important for an FDA clinical trial auditing.
The crux of the aim of an FDA clinical trial audit is to explore these among other issues:
An FDA clinical trial auditing can also cover specific, micro aspects of the investigation, during which it will look into these areas: