Certified Clinical Research Coordinator (CCRC) Practice Exam

Which entity is primarily responsible for oversight of clinical trials?

1. The sponsor

2. The IRB

3. The FDA

4. All of the above

The correct answer is: All of the above

The correct answer is that all of the entities listed play significant roles, with each having specific responsibilities in overseeing clinical trials. The sponsor, often a pharmaceutical company or contract research organization, is responsible for designing the trial, funding it, and ensuring that it complies with regulatory requirements. They have a vested interest in ensuring the safety and efficacy of the interventions being tested. The Institutional Review Board (IRB) serves as a critical checkpoint in the ethical oversight of clinical trials. It reviews the trial protocol and informed consent documents to ensure the protection of human subjects involved in the research. The IRB aims to assess risks versus benefits and ensure that informed consent will be adequately obtained. The Food and Drug Administration (FDA) oversees the clinical trial process to ensure that it adheres to federal regulations governing the testing of drugs, biologics, and devices. The FDA is involved in approving the initiation of clinical trials and monitoring their progress to safeguard participants against potential harm while ensuring the integrity of the data being collected. Since all these entities have crucial but distinct responsibilities in the governance and oversight of clinical trials, they collectively contribute to the protection of participants and the validity of the research findings. This makes the correct answer that all of the listed entities share this responsibility.