Who holds the primary responsibility for monitoring clinical trials?

The primary responsibility for monitoring clinical trials lies with the research sponsor. The sponsor is the entity that takes on the funding, management, and oversight of a clinical trial, ensuring that the study is conducted in accordance with regulatory requirements, the protocol, and Good Clinical Practice (GCP) guidelines. This involves overseeing the trial's progress, ensuring data integrity, and addressing compliance issues.

While investigators and clinical research coordinators play crucial roles in conducting the trial and managing day-to-day operations, it is the sponsor who holds the highest level of responsibility for the overall oversight, including monitoring patient safety and data quality. The Institutional Review Board (IRB) or Independent Ethics Committee (IEC) members are responsible for the ethical review of the study protocol and ensuring participant safety, but they do not directly monitor the day-to-day conduct or progress of the trial. Hence, the role of the sponsor in monitoring is central to the integrity and compliance of clinical trials.