Self-explanatory topic that is also somewhat related to this video as they both are themed around the less-talked about issues in clinical research.
Something that I recently learned from a medical monitor at a large pharma company is the fact that they check the pk samples for study participants and keep track of which research sites have a disproportionate number of non-compliant study participants. This is important because it can keep you from actually getting future studies from these Sponsors!
Just thought it was something I need to share. If you think follow up is not important, think again. Be persistent when it comes to your phone calls and emails and you should eventually get a response.
The title of this blog post sums it up. Keep your questions rolling in!!!!
The problem with most study file record retention issues in clinical research has to deal with the fact that no matter who you ask for answers, it seems that all you will get are more questions. I decided to do a video on this topic as it is a question that still gets asked all the time in this industry. Please remember that this is just my personal opinion, and when in doubt, contact your study Sponsor for their particular recommendations.
I was fortunate enough to finally meet Pat Stone, the former FDA auditor who has appeared on this blog many times throughout the years. In this interview Pat and I discuss how risk based monitoring is being viewed by the FDA and why many in the industry believe that monitoring has been really sloppy as of late. There were many interesting things that I learned during this mini-interview but the most striking was probably the fact that Sponsors routinely report CRO’s to the FDA anonymously for lackluster clinical trial management! This would add some further support to my theory that Sponsors are using this time of low study activities to square off CRO’s against each other and see who can perform better. I could not believe this, but apparently it occurs quite a bit. There are many other insightful findings here and I hope you find a few helpful.