In this video I answer a viewer’s question on what a trial master file is when it comes to a clinical research study. Essentially, this is where all the regulatory documents for a clinical trial are held, maintained and updated as needed at the Site level as well as at the CRO and Sponsor level. Let me know if I am missing anything here. Thanks for watching!
This week I was asked whether a PI can change the wording of an Informed Consent Form if they feel that a potential side effect of the investigational product is not listed. Another viewer asked a question regarding what clinical trial management software they can use if they are a small startup research clinic. I attempt to answer these questions and more in this video and I hope you find some value out of it.
In this week’s full length podcast, I dive into the viewer question box and pull out some interesting topics. The first is how CRO’s and Sponsors ensure that PI’s are truly reading the Serious Adverse Event Reports that they send to all research sites, or whether they are just signing and filing. The next question is how to tell the difference between a CRO and an SMO in clinical research. Another topic is PI availability versus the Sponsor’s ever increasing demands for more PI oversight and what we can expect in 2014 and 2015 in this industry. There are other topics I cover here as well and I hope you find some value out of it.
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.
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.
In my latest podcast I cover a wide variety of topics in clinical research such as blogging for research clinics, patient recruitment, negotiating budgets and getting hired as a CRA. As always, keep your questions coming you guys have been sending in great ones (dan at theclinicaltrialsguru.com).