Good Clinical Practice (GCP) Practice Exam

Who is the Coordinating Investigator?

1. An investigator overseeing a single site

2. An individual responsible for coordinating multiple investigators at different sites

3. A key decision-maker for the sponsor

4. A member of the Independent Data-Monitoring Committee

The correct answer is: An individual responsible for coordinating multiple investigators at different sites

The role of the Coordinating Investigator is fundamentally tied to the management and coordination of clinical trials that involve multiple study sites. This individual is responsible for overseeing the activities of several investigators and ensuring that the study protocols are consistently followed across different locations. This position is critical for maintaining the integrity of the trial data and ensuring that all sites are aligned in their approaches, thereby fostering effective communication and collaboration among researchers. In addition to coordination, the Coordinating Investigator also plays a key role in harmonizing practices across sites to uphold Good Clinical Practice standards. This includes ensuring that all participating sites abide by the same regulatory requirements and ethical considerations. More so, the Coordinating Investigator has a comprehensive understanding of the study's objectives, methodologies, and the overall timeline, making them an essential figure in the successful execution of multi-site clinical trials.