U.S. Clinical Trial Agreement (CTA)

Context:
- It can (typically) define the rights, responsibilities, and liabilities of parties, including CT Sponsors, CT Investigators and CT Institutions (regarding the conduct of a clinical trial).
- It can (typically) be composed of CTA Content, such as:
- It can provide legal safeguards to both investigators and sponsors regarding proprietary information, subject safety, and regulatory compliance.
- It can outline the terms for funding, indemnification, trial conduct, data ownership, and publication.
  - CTA Articles, such as:
    - ...
  - CTA Clauses, such as:
    - ...
  - CTA Provisions, such as:
    - ...
Example(s):
- A CTA signed between a Research University and a Pharmaceutical Company for testing a new drug.
- A CTA between a Medical Device Manufacturer and a Hospital for assessing the efficacy of a new medical device.
- ...
Counter-Example(s):
- A Material Transfer Agreement (MTA), which typically governs the transfer of tangible research materials between two organizations.
See: Clinical Trial, Informed Consent Document, FDA Regulations.

References

Web Chatbot
- 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.