In FY 2022, approximately 19% (96 of 504) of US Food and Drug Administration (FDA) Bioresearch Monitoring Clinical Investigator inspections were classified as either Voluntary Action Indicated (VAI) or Official Action Indicated (OAI)1.

If you are conducting a clinical trial, at some point in time you will be inspected by both the Sponsor and the national monitoring authority (e.g., FDA). Preparing for and hosting these inspections can often be time-consuming and stressful. Partly because inspections typically require multiple days of focused interviews involving trial personnel, data reviews, and tours of the facility where trials are conducted. In addition, due to the nature of an inspection, they are generally not considered part of the normal daily routine. Non-routine events can sometimes add a layer of stress.

What to Expect During an FDA Inspection

A FDA clinical investigator inspection is a critical part of ensuring the safety and efficacy of drugs and medical devices. The purpose of the inspection is to verify that data submitted to FDA is accurate, trustworthy, reliable, and in compliance with FDA regulations. During an inspection, you can expect the following:

  • Opening Meeting to introduce FDA inspectors and provide an explanation ofon the purpose of inspection including a list of documents and records to be reviewed.
  • Tour of the site, including pharmacy and other storage areas for the investigational product(s), to assess conditions under which the trial was conducted, and data collected.
  • Document and data review including study protocols, informed consent documents, case report forms, adverse event reports, and subject records. Facility (or site) records of equipment calibrations and environmental conditions may also be reviewed.
  • Interviews with key personnel to clarify records and assess if personnel involved in the study(ies) are aware of study/trial specific requirements, their job responsibilities, and regulatory requirements

How to Prepare for an FDA Inspection

Preparing for an FDA clinical investigator inspection is critical to ensure compliance with regulatory requirements and maintain the integrity of clinical trials. Consider the following key steps to successfully prepare for your next inspection:

  • Identify a team of responsible personnel to handle the inspection, including a lead coordinator who will oversee the process.
  • Understand FDA expectations by familiarizing yourself and your team with FDA regulations, applicable compliance program guidance manuals, and guidance documents related to your study/trial.
  • Conduct a site inspection to identify any potential compliance issues (e.g., equipment qualification/calibration, environmental monitoring conditions, drug accountability records). Document and correct issues immediately.
  • Improve interview techniques by reminding key personnel to provide clear and concise answers, be truthful and cooperative, and how to ask for clarification when necessary.
  • Conduct mock inspections to simulate a FDA investigator’s visit and identify potential areas of the inspectional process to improve (e.g., receiving visitors, location of inspection room, facility tour, provision of safety training).

Inspection Results and Responses

Even though an inspection may have concluded, the efforts and work around the inspection are not over. Post-inspection, several key steps will follow:

  • Audit close-out activities should include FDA investigators advising the site and site inspection team, prior to their departure, of any observations (483) that were noted during the inspection.
  • Inspection report will be prepared and issued by FDA outlining discussion items and detailed 483 observations (if any), along with expected response requirements and timelines, and an overall inspection classification (e.g., No Action Indicated [NAI], Voluntary Action Indicated [VAI], Official Action Indicated [OAI]). The inspection report may also include a list of documents reviewed.
  • Responses and corrective and preventive actions (CAPA) may be required if observations (483s) were made during the inspection. Responses must be complete and comprehensive and should include robust CAPAs to completely rectify the identified compliance issues and prevent them from reoccurring. It will be very important to address and resolve the observations within the timeframe provided; typically 15 days.

How JAF Can Help Your Site Become Inspection-Ready

JAF’s primary objective is to reduce inspection-related stress and ensure your team is always inspection-ready. Our holistic focus is multi-faceted. Together, we work with your site to implement strategies and techniques to:

  • Reduce time and resources wasted locating trial documentation.
  • Increase documentation standards.
  • Strengthen regulatory interview skills.
  • Reduce the risk associated with potential compliance challenges.
  • Ensure all team members are trained in regulatory expectations associated with clinical trial conduct and management.

JAF’s demonstrated methodologies target:

  • Reducing compliance gaps/risks.
  • Reducing time to respond to inspection-related discussion points or findings.

Do you know when your last or next inspection is? Are you preparing for an inspection as you read this? Have you wrapped up an inspection and need assistance responding to discussion points? If you answered yes to any of these questions, JAF can help! Regardless of trial size, location, primary endpoint, or trial duration, we are confident that you will recognize the benefits of a partnership with JAF. Schedule time with us now to discuss how JAF can help your trial site reduce inspection-related stress and increase inspection readiness.

JAF Consulting, Inc. is a demonstrated industry leader with over 30+ years of experience in clinical trial consulting, including but not limited to the provision of regulatory (GCP) and inspection readiness training, mock regulatory inspections, gap assessment services, and inspection-related remediation activities for clinical trial sites.

1 Bioresearch Monitoring (BIMO) Fiscal Year 2022 Metrics Presentation, United States Food and Drug Administration