This agreement is either a subcontracting or a subcontracting, in which a reference site recruits one or more sub-sites on which the clinical trial is carried out. Both the proponent and the trial site have key objectives related to the conduct of a clinical study. In the United States, the Sunshine Act strengthens control over payments to health organizations and health care professionals. The project description contains the necessary information on the nature of the agreement. Use this article as a guide if you are reviewing or issuing your next clinical trial agreement. However, you should always seek advice from a qualified lawyer on all conditions within the CTA. The payment terms and schedule will also indicate what the search site will not be paid for. For a clinical trial after authorization, the sponsor may not make medical equipment available free of charge. The timely publication and dissemination of research and study results are important principles for academic freedom granted to each member of the UCI faculty. However, the promoter may comment on the content of these publications, put in place intellectual property protection measures, or ensure that confidential information provided by the promoter is not improperly disclosed in such publications. These are legitimate business concerns and the UCI is ready to work with sponsors to address these concerns. However, the resulting agreement cannot prevent the UCI`s ability to freely publish the results of the research/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.
In general, the purpose of a clinical study is to collect safety and efficacy data for a particular medical device. Sponsored Projects (SP) is responsible for the verification, negotiation and legal implementation of agreements from external funding sources. Solving many contractual problems requires coordination between the external source of funding, the auditor and the PS; the participation of each party is essential to the success of a contractual agreement with conditions acceptable to both parties. In the case of industry-sponsored studies (for example. B regulatory studies of new drugs or testing devices, post-market, observational or registration studies), the proponent or its clinical research organization will submit a first CTA project. 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. Academic institutions have guidelines and regulations that define what can and cannot be accepted in a clinical study contract.