Before You Sign: a sponsor checks a clinical investigator’s FDA inspection history
Two sponsor colleagues look up their lead site’s FDA inspection history before the contract is signed. A short film; every name and record in it is fictional.
Every name and record in this video is fictional. The inspection history shown is a composite, not any real clinical investigator’s.
clinicalprecedent.com The site these videos are about: FDA inspections, findings and warning letters for clinical investigators, sponsors, CROs and IRBs.Transcript
Priya: Good news. We have our lead site for the phase two study.
Tom: Who?
Priya: Dr. Okafor. Strong CV, license is clean, three trials in our indication, and enrollment numbers are the best on the list. We've used the site twice before.
Tom: And the FDA inspection history?
Priya: We checked FDA's website. No warning letter... that's usually what we check.
Tom: There's a lot more to inspection history than a warning letter. Pull up Clinical Precedent. Type the name.
Tom: There. Inspected in 2023. Official Action Indicated. That's the most serious inspection classification FDA assigns. Often it leads to a warning letter, eventually.
Priya: That year we had a study running at that site.
Tom: We don't know if it was our trial that was inspected and got the OAI. Might have been. Or might have been a different one. FDA sends inspection findings to the clinical investigator, not typically to the sponsor.
Priya: That would have been good information to have.
Tom: Look at the findings. Informed consent. Conducting the study. Case histories. Control of the investigational drug.
Priya: Those are four key things BIMO inspectors look for in any trial. I'd want to know the details, and why it was OAI and not VAI. What do you suggest?
Tom: Three choices. Ask the site for their responses and corrective action plans to find out what the specific issues were and whether they've been corrected. Or we go out to the site ourselves and look at how they run things, with FDA's findings in mind. Or pick a different site without this history.
Priya: It's great to have this information before signing the fifteen seventy-two form.
Tom: Yes. And I'm adding Dr. Okafor to our Clinical Precedent watchlist. We should also add every principal investigator currently running any trials for us. When there's a new FDA inspection or enforcement activity at any site on the list, it's in our weekly email digest.