Clinical Trial Agreement Cle

When implementing a clinical study protocol designed by the sponsor, the university follows the sponsor`s instructions. As a non-profit public educational institution, the UCI cannot assume financial responsibility for injuries or damage resulting from the conduct of the clinical trial. Therefore, the UCI requires the promoter to have a sufficient policy or insurance program to support this obligation. The obligation for the Promoter to assume full financial liability does not apply to injury or damage caused by: 1) uCI`s failure to comply with the Protocol; 2) the UCI`s failure to comply with the FDA or other administrative requirements; or (3) the negligence of a faculty or university member. Principal Investigators should discuss all aspects of the clinical trial prior to the start of negotiations with their contract manager. The involvement of the UCI faculty in the development of the protocol and/or the design of the studies creates additional problems that both parties must fully address. Therefore, different or additional contractual conditions must be negotiated. The timely publication and dissemination of research and study results are important principles behind the academic freedom granted to every member of the UCI faculty. However, the Promoter may comment on the content of such publications, take steps to protect intellectual property or ensure that the Promoter`s confidential information is not improperly disseminated in such publications.

These are legitimate business concerns and the UCI is ready to cooperate with sponsors to address these concerns. However, the resulting agreement cannot prevent the UCI`s right to freely publish the results of the research/study. The standard agreement for the university`s clinical trials and the clauses proposed by the university during contract negotiations are based on the following assumptions: in general, each party must have the opportunity to terminate the agreement with a reasonable period of time. The Federal Government`s Office of Management and Budget sets the standards for calculating the indirect cost rate and the UCI regularly negotiates its rates with the audit authority of the U.S. Department of Health. . . .

About the Author