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

Where should the final trial close-out monitoring report be filed after completion of a study?

1. In the Investigator's files

2. In the CRF binder

3. In the Sponsor's files

4. In the IRB archives

The correct answer is: In the Sponsor's files

Filing the final trial close-out monitoring report in the Sponsor's files is essential because the sponsor is responsible for overseeing the conduct of the study, ensuring compliance with regulatory requirements, and maintaining comprehensive documentation related to the trial. This report serves as a critical summary of the study's completion, assessing whether the study was conducted according to the protocol, regulatory standards, and ethical guidelines. By having the report in the Sponsor's files, it becomes readily accessible for future reference during audits, regulatory inspections, and ongoing safety evaluations. This proper documentation supports the integrity of the study and provides a crucial record that can be reviewed if necessary for future trials or for addressing any findings post-study. In contrast, filing the report in the Investigator's files or the CRF binder might not ensure adequate retention and accessibility for all necessary stakeholders involved in the study. Placing it in the IRB archives would also limit its accessibility, as this repository is primarily for documents related to the approval of the study rather than its overall management and oversight post-completion. Thus, keeping it in the Sponsor's files aligns with best practices in clinical trial management and documentation.