Hello, I’m Dr. Jeff Kingsley and welcome to another edition of Riding in Cars With Researchers. Let’s talk about the FDA. The FDA is, of course, the regulatory body for research in the United States. FDA also performs inspections around the world as there is a lot of collaboration between regulatory bodies across the planet today – which is a good thing. In the research world, almost exclusively, anytime somebody mentions FDA, it has a bit of a negative tinge to it, like FDA is the bad guy. FDA is not the bad guy. Their job is to ensure data integrity and subject safety. Kind of the same as IRB (Institutional Review Board).
When you think about whether or not a protocol deviation needs to be submitted to the IRB, the rules are “did the protocol deviation affect subject safety or data integrity?” That’s a great way of summing up. That’s the FDA’s job. When they perform an inspection, their job is to find out can we trust the data (data integrity), and were subjects kept safe? Were the inclusion and exclusion criteria adhered to? Were subjects appropriately consented for the trial? That’s all subject safety. Appropriate conduct of the trial, the delegation of authority log the regulatory binder? That’s FDA’s job.
Now, why do I talk about this? Well, because if you’re a researcher and you’re doing any reasonable quantity of research, you’re going to have FDA inspections. What I would encourage you to do is don’t fear it. If you did your best, if you did high quality work, then your charts should be inspection ready. Will mistakes be found? Of course, mistakes will be found. Mistakes are found when we have monitoring visits. My issue is minimizing all mistakes that are capable of being minimized. Seek perfection. You will never attain perfection. But if you don’t seek it, you’ll obtain something even less than what you went after. Seek perfection and you’ll obtain excellence. You’ll never obtain perfection – can’t happen. Mistakes will always be made. Protocol deviations will occur for things that were out of your control like a super hot day and FedEx didn’t pick up until late and the dry ice melted. A patient who comes in late and occasionally human beings will make mistakes.
Don’t fear FDA. They’re the good guys. They’re there for a good reason. They are there to ensure that we are doing the highest quality work possible. And that’s reasonable. My companies and I have been through many FDA inspections with many different FDA agents. And what you hear is true – they’re all a little different. They all bring a different type of judgment – some hypercritical, others not. Some with more experience in the clinical research world, some not. And FDA is doing work to try and minimize that and normalize that, which is good, I’m glad FDA has taken that challenge on.
That’s it. My thoughts for the day. FDA – consider them your friend. Learn more about FDA. Learn their purpose. If you go to FDA’s website, it’s really is a horrible website. It’s not easy to navigate. Sorry, FDA! But if you go to FDA’s website, you can download FDA’s rules, you can download precisely what they will do in an inspection. It’s a rule book. It’s a recipe. This is precisely what FDA agents will look at and how they will look at it in an inspection. Educate yourself on how they will conduct the inspection. But it’s all good. Continue doing high quality research and don’t fear FDA.
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