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!
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.
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.
Ever wanted to own your own clinical research company? Ever wondered just how to go about doing that and what the minimal resources are to actually accomplish this goal? Well, look no further than my latest podcast where I discuss exactly what it takes to open a bare bones research clinic and how to go about expanding on that company. I have other videos on this blog that explain how to grow your business, but never really did a video on how to start a clinic. Let me know your thoughts on this!
So in the past I have blogged extensively about how clinicaltrials.gov can be used for researchers who are seeking additional clinical trials for their institutions. In this video response to a question I received from a small research clinic back East, I add some strategies that have worked in the past for myself and other colleagues of mine.
1.) Of course use clinicaltrials.gov for finding and filtering studies that you would like to get at your site.
2.) Network with other non-competing clinics in order to exchange study leads.
3.) Send your PI or Sub I to industry trade shows and annual conventions such as DIA and other more specialized ones.
4.) Work closely with any pharmaceutical sales reps in your region and get to know the medical liaisons that supervise them.
Of course there are other strategies, but these are some I have found to work well for me.
Today I got a fantastic question re when it is appropriate to list a clinical trial on the CV of a PI (Principal Investigator). Here is the question in its entirety without giving away the identity of the person who submitted it:
I am having trouble finding any type of published guidance on when to list clinical trials on a PI’s CV. I have seen a variety of formats and although some are prettier than others, my main concern is when it is permissible to list a particular trial on the CV. I was told, 5 years ago when I started out as a CRC, that it was okay to list a trial on the CV two years after completion of the trial. But I have never seen this instruction in writing. And why it not permissible to list a current clinical trial? Any suggestions would be appreciated. We are working on updating all our investigators’ CVs and we’d like to know that we are doing it correctly. I look forward to your response.
In this video, I provide my opinion on this, and that’s all I can really give because I am not aware of any specific guidelines for this topic aside from perhaps not breaking the Confidentiality of the Sponsor company paying for the clinical trial as well as the investigational medication. Of course, if anyone out there has a more specific answer, just let me know, but I’m pretty sure there is no actual rule for this one, just use your common sense and good judgement.