Good morning, everyone!  I do not do much work on clinical trials at my institution, but there are some questions being asked that many of us are trying to find answers for.  First, are there any cost principles that must be followed for clinical trials sponsored by pharmaceutical companies?  I could not find any and suspect that there are none.  Most of the regs I found for clinical trials involves human subjects (OHRP) and the FDA regs involving stats, devices, etc.  I have not found anything involving the financials.

There is a question as to whether or not a physician can be paid extra for being the PI on a clinical trial.  The sponsor is a pharmaceutical company, and the physician already receives his physician salary.  The money we receive for this clinical trial is for paying for patients' tests and other services.  My thought is that the money should then go directly towards paying for those services and should not be able to be used to pay the physician extra.  Plus, I do not see how it would be allowable for a physician to be paid extra for being a PI on a clinical trial.  However, I'm used to working with grants, in which PI's are not allowed to be paid more than their salary.  My original thought was that this would apply to clinical trials as well, but it's an area I do not know as much about.  Any thoughts?

Thank you so much!!
Kristy:)

Kristy Ford
Grant Management Manager
Memorial University Medical Center
Savannah, GA  31404
(912)350-6379

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