Clinical Trial Agreement Execution

Coordination between all parties, including the investigator and the external funding source, is essential to ensure the success of a contract on mutually acceptable terms. Pharmaceutical companies typically fund clinical study projects to study drugs and devices and play an important role in ensuring product safety. The company also obtains approval from the Food and Drug Administration (FDA) and markets the drug or device. 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. Academic institutions have guidelines and regulations that define what may or may not be accepted in a clinical trial contract. Policies focus on protecting participants as research subjects and minimize responsibility for human research. Effective July 1, 2009, the Health Science Center introduced new billing and budgeting grids. .