Good Clinical Practice (GCP) Practice Exam

In a Clinical Trial Agreement (CTA), the typical parties involved are the sponsor and the investigator or the institution conducting the clinical trial. The sponsor is responsible for funding and overseeing the clinical trial, while the investigator, who may represent an institution, is responsible for conducting the study according to the protocol, Good Clinical Practice (GCP) guidelines, and ethical standards.

The agreement outlines the responsibilities, obligations, and rights of both parties, including aspects such as funding, data ownership, intellectual property rights, and regulatory compliance. This collaboration is essential for ensuring the trial runs smoothly and ethically, and it establishes the framework for the relationship and expectations between the parties.

Other options do not represent the primary relationship defined within a Clinical Trial Agreement. For instance, regulatory authorities are not direct parties within a CTA but are instead involved in the oversight of clinical trials through regulations and guidelines. Similarly, a compensation committee does not play a central role in the agreement between the sponsor and investigator. Lastly, trial participants and the data monitoring board are not parties to the agreement itself; rather, participants are subjects of the study, and the data monitoring board oversees the integrity and safety of the trial.