Food and Drug Administration (FDA) inspections are a routine aspect of operating an investigational site. Even so, the thought of an FDA auditor visiting your facility can be incredibly nerve-wracking, especially if you haven’t taken the necessary steps to prepare.
There’s no way to predict when an inspection will occur, but there are plenty of things you can do to ensure the process goes smoothly. In this blog, we take a closer look at the different types of inspections and provide tips for adequate preparation.
What are FDA inspections?
FDA inspections are professional assessments conducted by clinical investigators. They’re used to make sure ongoing clinical trials are in compliance with all applicable rules and regulations, as well as ICH-GCP Guidelines.
Specifically, FDA inspections:
- Protect the rights and safety of trial participants
- Verify the accuracy of clinical trial data submitted to the FDA
- Assess compliance with regulations that govern the clinical trial
Why do FDA inspections occur?
FDA inspections are a routine part of the drug and medical device approval process. Just because your facility or trial site is selected for an inspection doesn’t necessarily mean you’ve done anything wrong.
Common events that trigger FDA inspections include new drug applications, researcher or patient complaints, and safety issues. Often, FDA inspections occur randomly. It’s estimated the FDA inspects about 1.9% of domestic clinical trial sites each year.
What are the types of FDA inspections?
FDA inspections fall into several distinct categories –– monitor visits, sponsor audits, and regulatory inspections. Let’s take a closer look at each type:
Monitor visit. A monitor visit is an inspection that oversees the progress of a clinical trial. It’s used to ensure a trial is conducted, recorded, and reported in accordance with established Good Clinical Practice (GCP) protocols.
Sponsor audit. A sponsor audit is independent of quality control and focuses on the design of the trial itself. Sponsor audits evaluate your adherence to standard operating procedures (SOPs). For example, they determine if tests were properly conducted, reported, and analyzed.
Regulatory inspections. A regulatory inspection analyzes the quality and integrity of the data collected during a clinical trial. These types of inspections usually occur after the submission of data for marketing approval of a new drug.
How can I prepare for an FDA inspection?
As previously mentioned, FDA inspections aren’t something to fear or stress out about. If you incorporate inspection preparation activities into your daily routine, you’re much less likely to encounter hiccups along the way.
Instead of doing everything at once, take a methodical approach. We recommend establishing a site-specific process that gets all of your team members involved.
Host an all-hands-on-deck meeting. During this meeting, determine who will host the FDA inspectors and coordinate all of their document requests. Next, write down the names of your principal investigator, your sub investigators, and the study coordinators. Beneath their names, create a bulleted list of each individual’s contributions.
Collect all of the necessary documentation. Clinical trials require extensive documentation. At the beginning of a new trial, create a dedicated binder that contains important paperwork like organizational charts and tables, employee training protocols, and responsibility matrices.
If you archive these documents at a satellite location, collect copies in advance. If these documents are housed online via the cloud, make sure the investigators have the necessary login credentials to access them.
Designate an inspection review area. FDA inspections are a time-consuming and methodical process. Therefore, it’s important the inspectors have access to a private room or separate area free of noise and distractions. If possible, make your inspection host available at all times. That way, if the inspectors have a question or need to make copies of a document, there’s no delay.
Train your staff. It’s important that each and every member of your team has a basic understanding of regulatory compliance and FDA expectations. Inspectors frequently quiz staff to glean insights on things like subject recruitment, source documentation, and data entry.
There’s no way to predict the specific questions they’ll ask, but performing a mock inspection can help.
At the very least, make sure your team members are able to answer basic inquiries like:
- What is the study design?
- What are the objectives of the study?
- What is the duration of the study?
- How do you obtain, record, and secure data?
A little bit of practice can reduce the risk of making a mistake or saying something silly under pressure.
It’s never too late to start planning for an FDA inspection
FDA inspections present unique challenges, but if you know what to expect, and take the time to adequately prepare, there’s nothing to fear. Inspections are an important part of clinical research. If you don’t already have a blueprint in place, now is the perfect time to develop one.
We hope you find these tips and insights helpful. If there are any recommendations you’d add to our list, please fill out the comment form below, and click “submit.” We look forward to hearing your thoughts!