What does a Clinical Trial Agreement (CTA) define?

What does a Clinical Trial Agreement (CTA) define?

• A. A contract for patient recruitment
• B. Responsibilities between the sponsor and investigator
• C. Guidelines for data management
• D. Criteria for selecting trial sites

Answer: (B)

A Clinical Trial Agreement (CTA) primarily outlines the responsibilities and obligations of the sponsor and the investigator conducting a clinical trial. This agreement serves as a legal document that details how various aspects of the trial will be managed, including funding, data ownership, publications, liability, and compliance with regulatory requirements. The roles and responsibilities defined in the CTA are crucial for ensuring that both parties understand their commitments and the framework within which the clinical trial will operate. This agreement is fundamental in clinical research, as it helps to protect the rights of the subjects involved while also ensuring that the trial can be conducted efficiently and ethically. It helps to mitigate risks by clarifying expectations related to the conduct of the trial, data handling, and reporting, thus fostering a collaborative relationship between the sponsor and the investigator.

A Clinical Trial Agreement (CTA) primarily outlines the responsibilities and obligations of the sponsor and the investigator conducting a clinical trial. This agreement serves as a legal document that details how various aspects of the trial will be managed, including funding, data ownership, publications, liability, and compliance with regulatory requirements. The roles and responsibilities defined in the CTA are crucial for ensuring that both parties understand their commitments and the framework within which the clinical trial will operate.

This agreement is fundamental in clinical research, as it helps to protect the rights of the subjects involved while also ensuring that the trial can be conducted efficiently and ethically. It helps to mitigate risks by clarifying expectations related to the conduct of the trial, data handling, and reporting, thus fostering a collaborative relationship between the sponsor and the investigator.