For industry-sponsored clinical trials, every CTA you receive must be downloaded with the protocol and consent form in the central registration of studies. The CTA is downloaded by the central study record to click under the “Agreements” tab. Contract administrators and sponsors are the main negotiators, but we inform the reviewer and staff during the process and insert them if necessary. Finally, this section of the agreement should clearly specify where the website should send invoices (name and contact information of the person) as well as payment terms (example: payment is made within 45 days). As a public non-profit educational institution, the university is subject to certain policies and rules on what it can and cannot accept in a clinical trail contract. These actions are aimed at protecting the well-being of those involved in research activities, promoting the university`s fundamental mission in teaching, research and public service, and minimizing the various forms of responsibility associated with human research. The university cannot cover sponsorship fees; This is why the university requires a minimum down payment of 10 to 20% of the total expected cost for the execution of the contract. If a project has significant start-up costs, the university may require a higher upfront payment. Studies conducted in accordance with FDA regulations require a contract between the study site and the sponsor or organization of the clinical study.
For industry-sponsored clinical trials, the clinical contract manager will audit a CTA within two weeks and, after receiving responses to requests from the investigator/staff, will refer the revised project to the sponsor. When implementing a clinical study protocol developed by the sponsor, the university follows the promoter`s instructions. As a public non-profit educational institution, the UCI cannot assume financial responsibility for injuries or damages resulting from the completion of the clinical trial. Therefore, the UCI asks the sponsor to maintain an insurance policy or insurance program sufficient to support this obligation. The obligation for the promoter to assume all financial responsibilities does not apply to injuries or damages caused by: 1) non-compliance with the protocol by the UCI; 2) Non-compliance with the FDA or other UCI regulatory requirements; or 3) the negligence of a faculty or university member. The contract does not need to be written in legal form. In order to ensure that all parties have a clear understanding of the definitions of legal concepts, the treaty should be written in clear language. The tasks, results and responsibilities of the test site must be clearly written and detailed to avoid confusion as to what is necessary to carry out the study. There are other common problems in developing a clinical trial agreement. These include: a CTA describes the details of what the clinical trial will cover and outlines in writing the formal agreements of each party for the completion of the study. It also contains the legal and financial conditions associated with the clinical trial.
The university`s research office has partnered with more than 20 industry sponsors to create master clinical trial agreements. These agreements set out fundamental legal conditions for studies, and study-specific information – including financial conditions and budgetary details – should be added to only one annex. The timely publication and dissemination of research and study results are important principles for academic freedom granted to each member of the UCI faculty.