The CROs can get it too

Sometimes it seems that whatever research sites do, there is always the threat of regulatory agencies coming down hard on investigators.  Don't do this a certain way or the FDA will get you.  Make sure you document this like so, or else an auditor will cite you.  After hearing this repeatedly a research site must wonder if the bullseye is always squarely on the investigator.  If you think I have good news about that, you're right..sort of.  First of all, the responsibility to properly conduct a research trial does lie first and foremost with the investigator, but the FDA also has its eyes on the sponsor and those who contract with the sponsor to conduct the research.

This fact was brought to light last week when the FDA issued a potent warning letter to ICON, citing their inability to properly monitor a research study.  Granted, the findings were likely issued to the corresponding investigators, but the number of citations was a reflection of the lack of a sound monitoring plan.  This warning letter was surprising to me because the types of errors noted are not nitpicky, rather they are surprising violations of a variety of FDA regulations and GCP.  I was shocked at the different findings noted by the FDA and even more surprised that the errors were not picked up during routine monitoring during the trial.  Obvious drug dosing inconsistencies, discrepancies between the source and CRF, lack of drug accountability; the list goes on and on, but the point I'm making here is that even though monitors will always remind investigators of the importance of following FDA regulations and GCP, the monitors are also held accountable for their work (or lack thereof, when applicable).   

So, research sites, read the warning letter and realize the burden of clinical research isn't squarely on your shoulders.  Remember too though, that patient safety is your responsibility and if you ever question the quality of monitoring efforts, you can discuss this with the study sponsor.  Both parties have a vested interest in quality study monitoring, and the FDA will take no sides when reviewing study data.

Read the monitoring letter in its entirety here