Issues in Negotiating Clinical Trial Agreements Len Paplauskas 14 Jun 1994 11:45 EST
There are several issues generally associated with the negotiation of clinical trial agreements. In addition to the recitals, budgetary understandings, and scope of work, most clinical trial agreements include provisions for one or more of the issues outlined below. At UCHC we are looking closely at our policies with an eye toward trying to reduce the amount of time lost to negotiation of clinical trial agreements, and may consider changing policies which tend to bog down these negotiations. As is rather traditional in such matters, we are seeking information from other universities as to their own policies and practices in such matters. In this regard, I would greatly appreciate any help you can provide, in terms of outlining your institution's approach. I have tried to develop a matrix which can easily be filled out by placing a number, which most closely corresponds to your institution's policy, in the space provided. I would be most grateful for your taking the time to complete the survey and mailing it back to me. As is also customary, a final analysis of the results of the survey will be compiled, and posted in this list. Thanks for your assistance. Len -------------------------------------------------------------------- Leonard P. Paplauskas Assistant Vice President for Research | 203-679-3173 University of Connecticut Health Center | FAX 679-2670 Farmington, CT 06030-5355 | | xxxxxx@neuron.uchc.edu | xxxxxx@sun.uchc.edu | -------------------------------------------------------------------- CODES FOR COMPLETING SURVEY: 1 = Imperative, must preserve right in all cases. 2 = Very Important, but may negotiate away right under compelling circumstances. 3 = Important, but will usually negotiate away right for something else. 4 = Not Very Important, but would be nice to have in the agreement. 5 = Prefer not to have issue addressed in agreement. INSTITUTION NAME (Optional): TYPE OF INSTITUTION (Check one): Private Institution? Public Institution? ***************************************************************** Issue * Institutional * * Preference/Policy * * (enter 1 - 5) * ***************************************************************** Fiscal Reporting To Sponsor * * ***************************************************************** Indemnification of Institution * * ***************************************************************** Indemnification of Research Subject * * ***************************************************************** Intellectual Property Rights To * * New Discoveries * * ***************************************************************** Publication Restriction - Prohibition* * ***************************************************************** Confidentiality Provisions * * ***************************************************************** Governing Law Preference * * ***************************************************************** Institutional/PI Ownership of Data * * *****************************************************************