standardclinicaltrialagreement.docVIP

STANDARD CLINICAL TRIAL AGREEMENT __________ (“Sponsor”), a {form of entity} organized under the laws of {State} and the Board of Regents of the University of Wisconsin System (“Site”), a state-controlled higher educational institution organized under the laws of Wisconsin (individually a “Party” or collectively “Parties”), enter into this Standard Clinical trial Agreement (“Agreement”) whereby Sponsor engages Site to conduct clinical study entitled according to the provisions of this Agreement and Protocol __________. 1.0. Definitions and Abbreviations Authorized Third-parties. People and organizations that are contractually or legally obligated to protect Confidential Information and who have been informed of their obligations. CRF (Case Report Form). A printed, optical or electronic document designed to record all of the protocol-required information to be reported to the Sponsor on each Subject. GCP (Good Clinical Practice). A standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials, that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of subjects are protected. In the U.S., the standards are set forth in the United States Code of Federal Regulations (“CFR”). Indemnified Employees. Employees, medical and professional staff, appointees, fellows, faculty, other persons with academic appointments, trainees and students of the respective Party. Intellectual Property. Inventions, expressions of ideas, discoveries, devices, data, mechanisms, substances, works, trade secrets, know-how, formulae and methods, including improvements, whether or not protectable by patent, copyright or other intellectual property rights. Invention. Any Intellectual Property conceived and reduced to practice, made or developed, in whole or in part, by or on behalf of Site pursuant to its conduct of the Study or derived