In which document must the sponsor outline their commitment to ensuring GCP compliance?

In which document must the sponsor outline their commitment to ensuring GCP compliance?

• A. Clinical Study Protocol
• B. Clinical Trial Agreement (CTA)
• C. Informed Consent Form
• D. Annual Report

Answer: (B)

The Clinical Trial Agreement (CTA) is the document in which the sponsor outlines their commitment to ensuring Good Clinical Practice (GCP) compliance. This agreement serves as a binding contract between the sponsor and the participating sites or investigators. Within the CTA, the sponsor delineates roles, obligations, and expectations, including adherence to regulatory requirements and ethical standards established by GCP. This commitment is crucial for protecting the rights, safety, and welfare of study participants, as well as ensuring the integrity of the data collected during the trial. By incorporating GCP compliance into the CTA, the sponsor establishes a framework for accountability and quality assurance throughout the trial process, emphasizing the importance of regulatory adherence from all parties involved. While the Clinical Study Protocol outlines the study's objectives, design, and methodology, it does not specifically detail the sponsor's legal commitments. The Informed Consent Form focuses on explaining the study to participants rather than the sponsor's responsibilities. The Annual Report chronicles the study's progress and outcomes rather than the initial commitments made by the sponsor regarding GCP compliance.

The Clinical Trial Agreement (CTA) is the document in which the sponsor outlines their commitment to ensuring Good Clinical Practice (GCP) compliance. This agreement serves as a binding contract between the sponsor and the participating sites or investigators. Within the CTA, the sponsor delineates roles, obligations, and expectations, including adherence to regulatory requirements and ethical standards established by GCP.

This commitment is crucial for protecting the rights, safety, and welfare of study participants, as well as ensuring the integrity of the data collected during the trial. By incorporating GCP compliance into the CTA, the sponsor establishes a framework for accountability and quality assurance throughout the trial process, emphasizing the importance of regulatory adherence from all parties involved.

While the Clinical Study Protocol outlines the study's objectives, design, and methodology, it does not specifically detail the sponsor's legal commitments. The Informed Consent Form focuses on explaining the study to participants rather than the sponsor's responsibilities. The Annual Report chronicles the study's progress and outcomes rather than the initial commitments made by the sponsor regarding GCP compliance.