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Re: Federally Sponsored Clinical Trials - Enrolling patients Mary Thornton 18 Feb 2011 19:42 EST

My take on this is that when we get one of these we are a "site" and not a sub-recipient of federal funds.  At a seminar on managing federal funds I asked about these and was told by the presenter that they are "fixed obligation" agreements and that they do not go on our Schedule of Expenditures of Federal Awards.  What we have to do (run the subjects through the trial) is fixed and when we've done that we've fulfilled our obligation and can accept the funds.  By the time we are paid we've earned the funds which have lost their "federal-ness."  That explains why the agreement does not flow down all the federal language.

I think this is an area that is widely misunderstood.  If people on the list think I'm wrong, I'm sure you'll let me know.

On Thu, 17 Feb 2011 17:58:40 -0500, Stephens, Michael (Mike) V. <xxxxxx@ORLANDOHEALTH.COM> wrote:

>Hello all - first, let me thank everyone for their help on recent questions I have had. You all have a wealth of knowledge and expertise!
>
>My question this afternoon is a hypothetical one.  I have noticed that at some institutions (hospitals, universities etc.) when they are sub-recipients on a federal grant          ( DOD, NIH etc.)  that happens to be a clinical trial where they are "simply" being paid to register or enroll patients in to a study, often time the agreement with the prime awardee is very "skimpy". Essentially, the agreements state something like....the University of XXXX (prime) will pay Jane Smith Hospital YYYY (sub) for 200 patients enrolled into the ZZZZ study.  Often times, from what I've seen, there are no budgets established and no specifics as to how the monies received from XXXX University will be expensed by the sub.   Just the fact the hospital is enrolling patients and the hospital gets paid.
>
>Question:   As these are federal dollars and are thus auditable under A-133, how do you handle/manage situations like this? Do you require your physicians to develop a budget by which the funds must be expensed?
>
>Again, thank you for help.
>Mike
>
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