Certified Clinical Research Coordinator (CCRC) Practice Exam

Who is primarily responsible for completing case report forms?

1. The Investigator

2. The Clinical Research Associate

3. The Clinical Research Coordinator

4. The Sponsor

The correct answer is: The Clinical Research Coordinator

The Clinical Research Coordinator is primarily responsible for completing case report forms (CRFs) in a clinical trial. This individual plays a crucial role in the management of clinical research data, ensuring that all participant data is collected, recorded, and reported accurately. The Coordinator works closely with trial participants to gather data, including medical history, ongoing treatment, and any adverse events that may arise during the study. Their responsibilities also include ensuring that the information is consistent with the source documents and that it adheres to protocol requirements, which is critical for maintaining data integrity and compliance with regulatory standards. By meticulously completing CRFs, the Clinical Research Coordinator helps facilitate the overall research process and aids in the efficient moving of data from the study site to the sponsor for analysis and reporting. The Investigator is responsible for the overall conduct of the trial at the site and may oversee the completion of the CRFs, but the day-to-day task of completing those forms typically falls to the Clinical Research Coordinator. While the Clinical Research Associate may review the forms and ensure compliance, their role is more focused on monitoring and oversight rather than direct data collection. The Sponsor is responsible for the funding and overall design of the study, but they do not interact directly with the CRFs in the same manner as