If all of the above criteria are met, the university may grant the proponent a number of rights to inventions made during the direct implementation of the clinical trial protocol. The terms in the model clinical trial agreement are used for Phase III or IV studies that meet the above criteria and involve little or no involvement of the investigator in the design or development of the protocol. However, the university verifies the terms of the patent on a case-by-case basis, preferring to do so with a thorough understanding of the work being considered. 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. A sponsored project includes negotiating, auditing and implementing legal agreements from external funding sources. Coordination between all parties, including the auditor and the external source of funding, is essential to ensure the success of the contract with mutually acceptable terms. During the negotiation of the contract for a clinical trial, academic institutions focus on acceptable clauses regarding high-risk issues such as: Data from a clinical trial are held by the study sponsor, unless the agreement provides for something else. Or a clinical website has finally published subject data without allowing the promoter to verify the results. The University`s standard agreement for clinical trials and the clauses proposed by the University during the contract negotiation are based on the following assumptions: Use this contribution as a guide for reviewing or developing your next clinical trial agreement.
However, you should always seek advice from a qualified lawyer on all conditions within the CTA. In general, the purpose of a clinical study is to collect safety and efficacy data for a particular medical device. Data or documents from raw sources generated by the university in a clinical study cannot be considered the property of the promoter, nor are they considered or treated as confidential information.