Clinical Trial Agreements Courses

Clinical trial agreements are one of the most important agreements in the pharmaceutical industry, as no research can begin without the right agreement between the sponsor and the host organization. They offer a contract that manages the relationships and responsibilities of both parties and provides for the sharing of risks, obligations, protection of science, conditions of cooperation, IP rights and much more. The faculty and staff of the UCI participate in many clinical trial projects to study drugs or trial equipment. These studies are typically funded by pharmaceutical companies and are an important part of the process of ensuring the safety and efficacy of the drug or device, obtaining food and drug administration (FDA) approval, and bringing a product to market. CTAS are one of the key documents that govern the conduct of clinical trials. They serve as a legally binding contract between a sponsor, a site and a researcher and describe the responsibilities and obligations of each party in the clinical trial. It is essential that researchers and sites understand the importance of developing, negotiating and executing ATCs, as effectiveness in these areas increases efficiency, protects researchers/sites and subjects, and advances research. As the market becomes more and more competitive, networking and introduction by the right person can make a big difference. That`s why we`ve partnered with Planet Pharma, a global human resources company that has a big impact on the clinical research industry. This will continue to help our interns & graduates find employment and develop their careers. 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. . . .