In most cases, despite what the Internal Revenue Service might tell you (ask them if they know what an SAE is), Principal Investigators can be independent contractors and not employees. As always, I must remind that I am not an attorney, nor do I play one on YouTube, so make sure you double check everything with a qualified professional.
Not everyone may be interested in this, but I have received lots of emails from research clinic owners who have aspirations of building a CRO. In this video I suggest a few strategies for actually making this dream a reality. As always, there are other methods that I am sure will work, but these are a few strategies that have worked well for myself and some of my clients.
So many people have been emailing me questions in regards to what it costs to open up a new research clinic. For the first 6 months of opening up, you have to expect that you will only have expenses and no income. The key to this entire strategy is to survive this initial 6 months while enrolling study participants on a consistent basis and keeping sponsors and cro’s happy by entering your data in a timely manner and keeping your queries down to a minimum. Through my own firm, I help Sites launch successfully by obtaining a sufficient amount of studies, training staff, creating SOP’s, and providing recruitment assistance. I hope this video provides some help for you and feel free to reach out to me anytime!
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.