Good Clinical Practice (GCP) Practice Exam

What is the role of regulatory authorities in clinical trials?

1. To conduct the trials themselves

2. To provide funding for the trials

3. To review submitted clinical data and conduct inspections

4. To develop clinical trial protocols

The correct answer is: To review submitted clinical data and conduct inspections

The role of regulatory authorities in clinical trials is primarily focused on ensuring the safety and efficacy of new medical interventions before they can be made available to the public. They accomplish this by reviewing submitted clinical data from trials to verify that the study was conducted according to rigorous standards and that the results are valid. This review process is essential to protect human subjects and to ensure that the benefits of a new treatment outweigh any risks. Additionally, regulatory authorities conduct inspections of clinical trial sites to ensure compliance with Good Clinical Practice (GCP) guidelines and other relevant regulations. These inspections help maintain integrity within the research process by ensuring that investigators and sponsors adhere to ethical standards and protocols. In contrast, while conducting trials themselves, providing funding, and developing protocols are important aspects of clinical research, these responsibilities typically fall to sponsors and research organizations rather than regulatory agencies. Regulatory authorities are focused on oversight, review, and ensuring compliance, rather than directly conducting research or providing financial resources.