Certified Clinical Research Coordinator (CCRC) Practice Exam

What must an investigator retain for two years after study termination or drug approval?

1. Subject recruitment materials

2. Financial records from the sponsor

3. Investigator's personal notes

4. Study records

The correct answer is: Study records

The requirement for retaining study records for two years after study termination or drug approval is grounded in regulatory guidelines, such as those from the FDA and NIH. These guidelines are designed to ensure accountability, transparency, and the integrity of clinical research data. Study records include essential documents such as informed consent forms, case report forms, study protocols, and other materials that detail the conduct of the study and the collected data. By retaining these records, investigators fulfill obligations to demonstrate compliance with Good Clinical Practice (GCP) and allow for adequate review in case of audits, inspections, or inquiries regarding the study’s findings, methodology, or participant safety. This retention period serves as a protective measure for both the subjects involved and the integrity of the clinical research process, ensuring that any questions that arise after study completion can be addressed accurately and comprehensively. In contrast, while subject recruitment materials, financial records from the sponsor, and personal notes might hold significance for various reasons, they do not generally have the same mandated retention requirements or are not crucial for demonstrating compliance with regulatory standards. Therefore, the emphasis is appropriately placed on the retention of study records, which provide a complete account of what was done during the study and support the reproducibility and veracity of the research findings