Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

Which role primarily works to ensure compliance with protocol during a clinical trial?

1. Data Manager

2. Clinical Research Associate

3. Clinical Research Coordinator

4. Principal Investigator

The correct answer is: Clinical Research Coordinator

The Clinical Research Coordinator plays a vital role in ensuring compliance with the protocol during a clinical trial. This individual is responsible for the day-to-day management of the trial, including overseeing participant recruitment, informed consent processes, and ensuring adherence to study protocols and regulatory requirements. The Clinical Research Coordinator acts as a liaison between the research team and the subjects, ensuring that all activities are conducted in accordance with the established guidelines. In this capacity, the coordinator monitors the progress of the study, manages data collection, and ensures that any deviations from the protocol are documented and addressed. Their deep understanding of the trial protocol enables them to identify and mitigate compliance issues proactively, making them key to maintaining the integrity of the study and in safeguarding the rights and welfare of the participants. Other roles, while crucial in their own respects, do not focus primarily on compliance in the same way. The Principal Investigator oversees the entire study and ensures that it is conducted according to the protocol but relies on the Clinical Research Coordinator for day-to-day compliance monitoring. The Clinical Research Associate supports the monitor site's compliance but primarily conducts site visits to ensure adherence rather than overseeing the ongoing operations. The Data Manager’s role is centered around data integrity and management rather than direct protocol compliance.