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

Where should documentation of site investigational product (IP) destruction be filed prior to archiving a study?

1. In the participant's medical files

2. In the study files of the Principal Investigator and Sponsor

3. In the IRB/IEC files

4. In the clinical trial master file

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

The documentation of site investigational product (IP) destruction should be filed in the study files of the Principal Investigator and Sponsor because this location ensures that the records are easily accessible for review and verification by key stakeholders involved in the study. Maintaining this documentation in the study files is critical as it provides a complete and accurate account of the handling of the investigational product throughout the trial. It allows the Principal Investigator and the Sponsor to track compliance with regulations and study protocols, ensuring that all necessary actions regarding the investigational product's destruction are formally noted and verifiable. Additionally, having the documentation centralized within these study files also facilitates inspections or audits, where regulatory authorities or oversight bodies may seek to review the handling and accountability measures for investigational products. Filing in the participant's medical files, IRB/IEC files, or the clinical trial master file does not provide the same level of direct oversight or accessibility in relation to the destruction of the investigational product, making the study files of the Principal Investigator and Sponsor the most appropriate choice for this documentation.