Understanding FDA audits

The FDA conducts various types of audits on parties involved in veterinary clinical studies to ensure compliance with regulatory standards and the integrity of data submitted for New Animal Drug Applications (NADAs) and Abbreviated New Animal Drug Applications (ANADAs). These audits include inspections of clinical investigators, study sponsors, nonclinical laboratories, and institutional review boards (IRBs).

The primary purpose of these audits is to verify adherence to Good Laboratory Practice (GLP) regulations, confirm the accuracy and reliability of study data, and ensure the welfare of participating animals. By conducting these audits, the FDA aims to ensure the quality and integrity of veterinary clinical research, thereby protecting public and animal health and ensuring that veterinary products are safe and effective for their intended use.

While FDA audits can seem daunting, a clear process, good guidance and proper preparation can help you successfully navigate the audit.

Reasons for Audits

There are three main reasons you may be audited: A routine audit, a directed audit, or a for-cause audit.

• Routine Audits: Routine audits are generally scheduled at random and may involve up to 20% of the study sites for a given study. These are typically conducted 3-6 months after the sponsor has submitted the study for approval.
• Directed Audits: Directed audits are requested by the review group (in the Office of New Animal Drug Evaluation or ONADE) for specific studies. The review team may ask that the audits be randomly assigned to participating investigators (routine), or they may ask that specific sites or sites with high enrollment be audited (directed). Other triggers for a directed audit may include sites that are new to clinical trials, sites with previous compliance concerns, or sites that have one or more serious adverse event(s).
• For-Cause Audits: For-cause audits are generally performed in response to an event, situation, or complaint for which the Division of Compliance or the review team needs more information or investigation. These audits are frequently unannounced and can be conducted at any time, during or after the completion of the study.

The audit process

1. Audit notification

If you are selected for an audit, you’ll likely be contacted via email or phone, usually between 3-6 months after the submission of the completed study (which can be months to even years after the study has closed at your study site). In the event you are not available during the requested audit time, the inspector may consider changing the dates or coordinating with you in another manner so the audit can proceed. The inspector may provide notice anywhere from a few days to a few weeks prior to their arrival.

2. Contact your Argenta representative

Once you have been alerted of an upcoming FDA audit, it is important to immediately notify your CRA so they can get to your clinic ahead of the inspection. If you cannot contact your CRA, reach out to anyone in clinical R&D. The Argenta representative will help you prepare for the audit by guiding you through what to expect and discussing potential issues, like adverse events and deviations. They can also advise on which site personnel should be present and assist the team with site preparation.

3. The audit

The inspector will start with a brief interview with the investigator. They will present their credentials, an FDA Notice of Inspection (Form 482), and an outline of the agenda for the audit, such as reviewing compliance, drug inventory, and other study documentation.

Your Argenta or Sponsor representative will facilitate access to electronic data capture (EDC) systems, forms, binders and explain the protocol as needed. Some inspectors prefer to be walked through the materials, while others may review them independently. The CRA will assist in whatever capacity they can and will support the clinic staff throughout the entire process, ensuring the clinic staff can continue to perform their normal clinic duties with minimal disruption.

4. Post-audit process

At the end of the audit, the inspector will arrange an exit interview with the investigator to present their findings and make any final clarifications. If there were no significant findings or only minor suggestions from the inspector, the audit will conclude at this time. If any major compliance issues were discovered during the audit, a form 483 would be issued, and the inspector would provide guidance to the site on how to respond to and/ or address the findings.  Know that if you have been audited, this will not adversely affect the findings or evaluability of cases, as long as Good Clinical Practice guidelines have been followed.

How to prepare for an audit?

If you have been alerted of an FDA Audit, the next step after calling your CRA is to get organised:

• Prepare a list of studies your clinic has participated in over the past few years
• Keep all study documentation organised
• Ensure that study documentation is available and complete. Consider storing materials together in a safe place where they are easily accessible.
• Even if you are not being audited, it is still best practice to keep clinical study materials organised and safely stored.

To keep this information on FDA audits readily accessible, download your copy here.

Argenta’s commitment to supporting clinical investigators

At Argenta, we are dedicated to supporting our clinical investigators through every step of the clinical study, including audits.

Dr. Jennifer Ogne-Stevenson, Head of Veterinary Services at Argenta, Kansas, shares the key things to remember.

Please, don't hesitate to contact us if you are interested in becoming a clinical veterinary investigator and learn more about how we support you in every step of the process.