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Re: Contract-Language Question Kristy Ford 21 Aug 2008 12:16 EST

From the little bit I've worked with clinical trials and seeing the terms used in clinical trial agreements with pharmaceutical companies, it sounds like Pharma is referring to you as the sponsor, because your institution is conducting the research.  These types of pharmaceutical companies are used to dealing with clinical trial lingo, which in some cases is slightly different than that of the grant administration world.  They view an institution conducting a clinical trial to be sponsoring it.  It is where the clinical trial is being offered or held.  Much like if you go to a conference held at a particular conference center, they may say it is being sponsored by that conference center.  Although your agreement is a research agreement, that is the type of lingo pharmaceutical companies and the FDA are used to using.

Hope this helps!
Kristy

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

>>> "Chowfin, Sunita" <xxxxxx@ACP.EDU> 8/21/2008 12:49 PM >>>
Hi all,

I have a question for you in regard to contract language. We're reviewing the terms of a research agreement from pharma. The contract language is written so that we (the Institution) are the "sponsor," not the company funding the study.

I requested the contract language be changed to state the company is the sponsor (i.e., is providing the funding for the study - to be congruent with our grant lexicon) and was advised: "... (the company) is NOT the sponsor of the study insofar as the FDA and the like are concerned ... (the company is) providing financial support and/or drug to an Investigator-initiated Study. The Institution is the sponsor."

Is the concept of an awardee being referred to as the "sponsor" something new and accepted? Am I being too nitpicky regarding the contract language and should I just let it go?

Your insight and advice are appreciated. Thanks.
Sunita M. Chowfin
Grants Administrator
Office of Grants Administration
Albany College of Pharmacy
O'Brien Building, Room 115
106 New Scotland Avenue
Albany, NY 12208
(518) 694-7144 . Office
(518) 694-7058 . Fax
xxxxxx@acp.edu<mailto:xxxxxx@acp.edu>

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