Discusses the overall purpose of a CTA, roles and responsibilities of the CTA parties and how CTA fits into the research enterprise. The module also compares and contrasts clinical trials with drugs, biologicas and devices from a CTA perspective. In industry-sponsored clinical trials, the sponsor usually launches the CTA. If you receive such a document, it must be uploaded to the central record of the study, as well as the protocol and declaration of consent. These documents are automatically uploaded to the click system. The CTA is then assigned to a clinical contract administrator. You can answer any questions you have about a CTA for clinical trials. Both the sponsor and the study site have primary objectives related to the conduct of a clinical trial. CTAS are one of the key documents that govern the conduct of clinical trials. They serve as a legally binding contract between a sponsor, a site and a researcher and describe the responsibilities and obligations of each party in the clinical trial. It is essential that researchers and sites understand the importance of developing, negotiating and executing ATCs, as effectiveness in these areas increases efficiency, protects researchers/sites and subjects, and advances research. A CTA is required when we conduct a clinical trial with another party, including industry, an academic partner or a clinical research organization. We use CTA to define study-specific details, such as for example.
B the number of subjects to be registered, ownership of study data and/or samples, all intellectual property rights, publication rights and other matters related to the study. When it comes to financing, the agreement clearly defines how much to pay and when. Academic institutions have guidelines and regulations that define what may or may not be accepted in a clinical trial contract. Policies focus on protecting participants as research subjects and minimize responsibility for human research. There are several persons authorized to sign documents and agreements relating to clinical research and, therefore, the power to bind UB and our clinicians to the conditions contained in such agreements. Investigators, employees, and departments are not authorized to sign agreements on behalf of UB, our affiliates, the State University of New York, or as individuals.