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

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

1. The site's records

2. The sponsor's files

3. The regulatory authority's file

4. The ethics committee's records

The correct answer is: The sponsor's files

The final trial close-out monitoring report prepared by the Clinical Research Associate (CRA) should be filed in the sponsor's files. This is crucial because the sponsor is responsible for overseeing the conduct of the clinical trial and ensuring all documentation is complete and compliant with regulatory requirements. The close-out report typically includes a summary of the trial’s execution, any outstanding issues, and confirmation that all data and samples have been appropriately managed. Filing it with the sponsor allows for centralized management of trial documentation and supports accountability and transparency throughout the clinical trial process. It also facilitates future inspections by regulatory authorities and audits, ensuring that all necessary information about the trial closure is readily accessible. Keeping such records with the sponsor underscores the obligation they have in maintaining adequate documentation for the study duration and beyond.