So I did many videos on informed consents in clinical research on this blog, but today I am answering a viewer’s email on what I think are some of the critical components of what should be included in an informed assent for a minor that will be participating in a clinical trial. Let me know your thoughts on this and if I am missing anything!
I received a question from a research clinic asking what to do if the PI feels very strongly that a subject does not qualify, but the Sponsor insists that the subject does indeed qualify. These issues surprisingly, usually happen in reverse: Sites are trying to enroll certain subjects who may not truly qualify. As in all matters, this is truly a case by case type of situation, but ultimately it is up to the PI to ensure the safety and well being of his study participants, so safety should trump all other variables. Let me know your thoughts.
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.