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

Prior to archiving a study, where should the documentation of investigational product (IP) destruction at the site be filed?

1. Institutional Review Board records

2. Study files of the Principal Investigator and Sponsor

3. Clinical research assistant files

4. Government regulatory authority

The correct answer is: Study files of the Principal Investigator and Sponsor

Filing the documentation of investigational product (IP) destruction in the study files of the Principal Investigator and Sponsor is the most appropriate option because it ensures that both key parties involved in the research maintain a comprehensive and accessible record of all study-related activities and compliance with regulatory requirements. The Principal Investigator is responsible for the conduct of the study and the oversight of all aspects of investigational product management, including its destruction. The Sponsor, who typically funds and oversees the study, also needs an accurate record of IP handling to ensure accountability and transparency. Keeping this documentation together helps maintain an organized archive and allows for easy retrieval should the need arise for audits, inspections, or future reference during the life cycle of the study. The other options are less suitable as they do not centralize the pertinent information for those directly responsible for the study. Institutional Review Board (IRB) records focus more on ethical considerations and approvals rather than operational aspects like product destruction. Filing in clinical research assistant files may not provide a structured environment for retaining essential study documentation, and submitting this information to a government regulatory authority is more appropriate for initial submissions rather than for internal documentation management. Proper filing in the study files ensures that a complete and accurate record is maintained, as mandated by regulatory guidance.