Budget negotiations are conducted separately, although budget and contract negotiations must be completed before a CTA can be signed. Negotiations can vary and depend on several factors, including the nature and complexity of the study, whether there is a Master-CTA, the participation of our related companies, the responsiveness of the sponsor and the auditor or staff. There are several people with the power to sign documents and agreements relating to clinical research and, therefore, the power to bind UB and our investigators under these agreements. Investigators, employees and departments are not authorized to sign agreements on behalf of UB, our affiliates, New York State University or as individuals. A CTA is required when we conduct a clinical trial with another party, including industry, university partner or clinical research organization. We use the CTA to define specific details for the study, such as the number of subjects to be registered. B, ownership of the data and/or samples of the study, all intellectual property rights, publication rights and other issues to be expected with the study. If it is funding, the agreement clearly specifies how and when the payment of the money is made. 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. In the case of an industry-sponsored clinical trial, such an agreement may be reached with the sponsor or a clinical research organization that manages the study for the sponsor.
A CTA defines the scope of the work and formalizes the agreements between the parties for the completion of the study. It contains legal and financial conditions related to the completion of the study by the university. A clinical trial agreement (ATC), a clinical study agreement or a clinical research agreement are all the names of an agreement or contract between the university and another party for the conduct of a clinical trial or clinical trial. 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.