The trail of an FDA clinical trial audit

Key Takeaway:

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.

When it established the BIMO Program, the FDA's aims were:

  • To ensure that the safety, rights, and welfare of the subjects who participated in FDA-regulated clinical trials were protected
  • To verify that the data derived from these clinical trial, which were submitted to the FDA, were accurate and reliable, and
  • To ensure that clinical trials were compliant with statutory requirements and the FDA's regulations relating to the conduct of these trials.

In carrying out FDA clinical trial auditing, the FDA could make site visits to any of these:

  • Clinical investigators
  • Institutional Review Boards (IRBs)
  • Sponsors
  • Contract research organizations (CRO)
  • Monitors
  • Bioequivalence analytical laboratories, and
  • Nonclinical (animal) laboratories

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.

How is the FDA clinical trial auditing done?

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.

Aspects of a clinical trial that the FDA audits

The crux of the aim of an FDA clinical trial audit is to explore these among other issues:

  • Who in the organization performed the different aspects of the protocol, such as verification of inclusion and exclusion criteria, who got informed consent from subjects, who observed and collected relating to adverse event data, etc.?
  • Is there approval from the IRB of these aspects of the protocol?
  • Was there adherence to the sponsor's protocol and investigational plan, and if there were deviations, were they recorded and reported appropriately?
  • Were the consent forms and other related documents duly signed by the subject or a legal representative?
  • Was there compliance with the delegation of the authority for conducting the study or some of its aspects, if any?

An FDA clinical trial auditing can also cover specific, micro aspects of the investigation, during which it will look into these areas:

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