Although each document is reviewed on a case-by-case basis, there are a number of key issues that are common to most clinical trial agreements. The following points are negotiated by SP with the sponsor: This type of agreement can be initiated by a sponsor or reviewer. A clinical trial agreement, initiated by a sponsor, is required if the drug or device under review has financial support. Both the proponent and the trial site have key objectives related to the conduct of a clinical study. Or a clinical website has finally published subject data without allowing the promoter to verify the results. 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. Explains the overall purpose of a CTA, the roles and responsibilities of the parties to the CTA and how the CTA integrates into the research enterprise. The module also compares and compares clinical trials with drugs, biologics and devices from the CTA perspective. A CTA must include the management of the publication and presentation of clinical data by the sponsor. A clinical trial contract initiated by the investigator is required when an industrial sponsor provides the device or drug to be examined and/or the necessary funding for the study. Confidentiality Agreement (CDA or NDA): an agreement that allows faculties and collaborators at the University of Washington to exchange confidential information with outside third parties who are required to protect and respect the confidentiality of information.
In general, CDAs are concluded for the purpose of studying possible research cooperation or a licensing agreement. As a general rule, the university negotiates a fixed fixed price by technical contract with a payment plan. These schedules generally include regular payments at regular intervals or payments made as a result of milestones (e.g. B, the registration of a certain percentage of subjects, the submission of a number of case report forms, etc.). The university cannot cover sponsorship fees; This is why the university requires a minimum down payment of 10 to 20% of the total expected cost for the execution of the contract. If a project has significant start-up costs, the university may require a higher upfront payment. As a government-subsidized institution, the university must recover all research costs from external sponsors, including all related operating costs. In other words, for-profit research would be subsidized by public funds.
In the United States, the Sunshine Act strengthens control over payments to health organizations and health care professionals.
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