Certified Clinical Research Coordinator (CCRC) Practice Exam

Who assumes responsibility for the initiation and management of a clinical trial?

1. Research coordinator

2. Ethics board

3. Sponsor

4. Investigator

The correct answer is: Sponsor

The sponsor is the entity that assumes responsibility for the initiation and management of a clinical trial. This can be a pharmaceutical company, a biotech firm, or any organization that funds and oversees the research. The sponsor plays a crucial role in determining the study design, securing regulatory approvals, and providing the necessary resources to conduct the trial, including financial support and necessary materials. While the investigator is responsible for conducting the trial in accordance with the protocol, and the research coordinator manages day-to-day operations, including participant recruitment and data collection, their roles are subordinate to the overarching responsibilities held by the sponsor. The ethics board, or Institutional Review Board (IRB), oversees the ethical aspects of the trial but does not manage it; its role is to ensure the protection of participants and adherence to ethical standards. Thus, the sponsor is rightly identified as the primary entity responsible for both the initiation and the overall management of a clinical trial.