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

Who typically files the accounts of investigational product destruction prior to the archiving of a study?

1. The research coordinator

2. The site monitor

3. The Principal Investigator and the Sponsor

4. The regulatory affairs manager

The correct answer is: The Principal Investigator and the Sponsor

The Principal Investigator and the Sponsor are responsible for filing the accounts of investigational product destruction prior to the archiving of a study. This responsibility stems from their roles in overseeing the study's integrity, compliance with regulatory requirements, and ensuring that proper documentation is maintained. The Principal Investigator has the primary accountability for the conduct of the clinical trial at their site, which includes ensuring that all investigational products are handled according to protocol and regulatory standards. Meanwhile, the Sponsor, who is the organization or individual that initiates, manages, and finances a clinical trial, has a vested interest in documenting product accountability, including destruction, as part of their overall responsibility for the study. Proper documentation of investigational product destruction is important for compliance, safety, and regulatory reasons. It provides an official record that the product has been properly disposed of, preventing any misuse or return to the research settings. This filing also supports the transparency required in clinical research and can be important for future audits or inspections by regulatory agencies. In contrast, while the research coordinator may assist in data collection and documentation, they do not typically have the final authority over such significant reports. The site monitor's role is focused on ensuring compliance and not directly involved in filing destruction reports. The regulatory affairs manager