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

After completion of a study, where should the final trial close out monitoring report prepared by the CRA be filed?

1. Sponsor's files

2. Researcher's personal files

3. Ethics committee records

4. Participant's medical records

The correct answer is: Sponsor's files

The final trial close out monitoring report prepared by the Clinical Research Associate (CRA) is a crucial document that summarizes the monitoring activities conducted throughout the study. This report should be filed in the sponsor's files because the sponsor is responsible for overseeing the conduct of the clinical trial, ensuring compliance with regulatory requirements, and maintaining comprehensive records related to the study. By placing the report in the sponsor's files, it ensures that all relevant documentation is consolidated in one central location, facilitating future audits, inspections, and reviews by regulatory authorities. This practice is essential for maintaining transparency and accountability in the research process. While other options like the researcher's personal files or participant's medical records may contain important information, they do not serve as the primary repository for official study documentation. Researcher files may not be accessible for broader oversight, and patient records are more focused on individual health data rather than study compliance and monitoring. Ethics committee records are important for their own purposes but do not encompass all aspects of the study's operational documentation. Therefore, the sponsor's files are the appropriate and necessary location for storing the final trial close out monitoring report.