In the diagnosis of imaging and molecules, a research study is considered a clinical trial when the information obtained from the test concerned influences medical decisions and therefore has an impact on the outcome. Studies that do not use the data in this way, but simply examine a new diagnostic approach, are not considered clinical trials. The publishing rights contained in a CTA may depend on the type of organization that conducts the clinical trial. The CTA sets a time limit for verification by the manuscript promoter and the verification may allow the sponsor to require the removal of confidential information, comment or even require a publication period so that the sponsor can apply for patent protection. In the negotiations on publication, it is important that a CMA fulfills its mission and thus preserves its freedom to publish and disseminate information. It is also important to ensure that any proposed use of the publication by the promoter is subject to copyright. Since the sponsor`s use of the organization`s name can improve its market share, it is important to limit the use of one party`s name by the other party. A court decision or even a designation in an action can ruin a company`s reputation or financial situation. Therefore, a CTA should determine whether one party will compensate, defend and/or keep the other party unscathed. Depending on the type of organization conducting the study, the conditions of compensation can be decisive, so the CTA should explicitly define the conditions of compensation, including possible notification and/or cooperation requirements and disclaimers. In addition, a party`s insurance coverage, and even its liquidity, can determine the amount and extent to which the party can effectively meet its obligations of compensation. Therefore, the CTA should require that each party (i.e.
the sponsor and the CMA) be required to have an assurance of the nature and amount that are appropriate and customary for the conduct and sponsorship of the study, or to maintain a similar self-insurance program. In addition, if one of the parties is a foreign entity, it may have coverage limits or additional insurance obligations that the CMA must be aware of. 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. Investigators should provide MS with a copy of the draft clinical trial agreement (ATC), the protocol and a company contact person as soon as possible. If a master`s contract already exists between the sponsor and the University of California, the negotiation process is usually expedited.