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When a signed ATC is agreed, sponsors are entitled to receive data collected prior to the termination of the contract and sites receive compensation for testing activities carried out by research staff. Equipment Transfer Agreement (MTA): an agreement regulating the transfer of research materials between the university and a third party. These agreements are concluded through the Technology Management Board. Clinical Research Agreement (CRA): An agreement directly with a for-profit company providing funding or a drug/device for a clinical trial may be entered into for an agreement initiated by the sponsor or initiated by the clinical investigator.“ Consortium agreement: an agreement regulating the terms of membership in a consortium. Or a clinical website has finally published subject data without allowing the promoter to verify the results. 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. During the negotiation of the contract for a clinical trial, academic institutions focus on acceptable clauses with respect to high-risk issues such as: Use this contribution as a guide when reviewing or developing your next clinical study agreement. However, you should always seek advice from a qualified lawyer on all conditions within the CTA.

Kunal is the founder of the clinical trial podcast, a podcast and blog platform for clinical researchers. Its goal is to interview leading experts in clinical studies management to help you accelerate your career and be a more effective guide. He enjoys bringing together like-minded people, introducing new ideas and immersing himself in a continuous learning environment. Both the proponent and the trial site have key objectives related to the conduct of a clinical study. Cooperation agreement: an unfunded cooperation agreement in which the UC and the other party contribute to the conduct of research. This can be done with a for-profit, non-profit or university organization. Data Use Agreement (AEA): an agreement between the university and another party (university, government agency or company) for the exchange of a limited data set in accordance with HIPAA for research promotion purposes. The agreement ensures that data exchanged in accordance with data protection legislation is properly processed. Finally, this section of the agreement should clearly specify where the website should send invoices (name and contact information of the person) as well as payment terms (example: payment is made within 45 days).

A CTA describes the details of what the clinical trial will cover and outlines in writing the formal agreements of each party for the completion of the study. It also contains the legal and financial conditions associated with the clinical trial. Whether you are new to clinical research contracts or a ninja contract, at any time, there is at least one agreement that you can imagine that one could have formulated otherwise. A CTA is required when we conduct a clinical trial with another party, including industry, university partner or clinical research organization.