U.S. Clinical Trial Agreement (CTA)

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A U.S. Clinical Trial Agreement (CTA) is a U.S. healthcare-related agreement for coordinating clinical trials involving pharmaceuticals or medical devices in the United States.



References

2023

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    • The U.S. Clinical Trial Agreement (CTA) is a comprehensive, legally binding contract that defines the roles, rights, responsibilities, and obligations of all parties involved in a clinical trial; including the sponsor, the research site, and the researcher(s). It provides detailed coverage of aspects ranging from the specifics of the study drug or device, the financial commitments, and the handling of proprietary information, data, results, to aspects of publications and intellectual property rights. The CTA is essential to minimize legal disputes and safeguard the rights of all involved parties. This process often involves the use of a Confidentiality Disclosure Agreement (CDA) to protect sensitive trial information. The creation, negotiation, and enactment of the CTA are vital to ensuring efficient clinical trial management. Furthermore, several resources, tools, and training programs exist to support this process and foster improved collaboration between industry sponsors, academic medical centers, and research sites.