The first thought that typically comes to mind when you hear about an upcoming FDA inspection at your site is the logistics– where to meet, document review, and your facility’s condition. There are however, other factors to keep in mind for both on-site and remote inspections.
This article will briefly cover the basic principles of a GCP inspections and what clinical site staff should expect and keep in mind for future inspections.
FDA Investigators (commonly known as Inspectors) regularly visit clinical research sites to conduct inspections and ensure GCP requirements are being followed. In fact, according to FDA’s inspection metrics, almost 800 BIMO or Bioresearch Monitoring inspections are conducted at clinical research sites every year (with the exception of the pandemic in year 2020).
What to expect
Whether an FDA Investigator conducts an on-site or remote inspection, he/she will need to show his/her credentials and show an FDA-482 prior to discussing the inspection’s purpose, scope and number of days according to the size and complexity of the trial(s) being inspected.
In general, the first day of inspection will also require the review of pre-inspection records, site files and subject files. Interviews will also be conducted with the study personnel, such as the study coordinator(s) and the Principal Investigator to determine compliance to the regulations, protocol/investigational plan and other study-related procedures.
At the end of each day, the inspectors will do a summary of findings, as well as a general verification of their checklist to confirm if inspection criteria were fully covered and all requested documentation received.
The most important aspects that FDA Investigators focus on are patient safety and data integrity. They will look at patient consents, adverse event/experience reporting, and anything that could potentially jeopardize the patient’s safety. They also ensure data integrity by confirming the absence of data transcription errors and compliance to the regulations, protocol and other study requirements according to CPGM (Compliance Program Guidance Manual) for Clinical Sites.
What to keep in mind
- Plan Accordingly – Keep a checklist available to ensure documents are inspection-ready. site staff are adequately prepared and technology is properly working for provided access and sharing documentation (especially for remote inspections).
- Practice Interview Skills –During the interviews, it is important to inform your staff about the Do’s and Don’ts of interviewing including how to answer the questions asked by the inspectors. For example, all site staff should be prepared to discuss topics such as:
- Training – Safety-related, Protocol, Case Report Form
- Delegation of study-related tasks/PI Oversight
- Subject recruitment
- Informed consent process
- Source documentation
- Data entry
- Investigational product or device handling
Interviewees only need to answer the question directly with no additional information. Moreover, if you don’t know the answer to a certain question, it is acceptable to say that you don’t have access to that information at the time and that you will get back to them with an answer later.
- Don’t get defensive/ask questions – Be sure that none of your staff are getting defensive with the FDA inspector as this might come back to haunt you.
- Ask for Clarification – If you need clarification or have questions about the findings reported by the FDA inspector, it is totally acceptable to point them out. However, defensive behavior is never a good idea.
Inspections are an important aspect of clinical research trials. A proactive approach and consistent preparation from clinical site personnel at the start of a trial, results in a successful inspection at the end.
Need an Inspection Preparation checklist for your site? Feel free to download our free Inspection Preparation Checklist as a preparation tool.