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

Before archiving a study, where should documentation of investigational product (IP) destruction be filed?

1. In the sponsor's central files

2. In the study files of the PI and Sponsor

3. In the FDA submission package

4. In the subject's medical records

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

Filing documentation of investigational product (IP) destruction in the study files of both the Principal Investigator (PI) and the Sponsor is essential for maintaining an accurate and comprehensive record of the study. This documentation serves as a critical component of the overall study archive, providing evidence that the investigational products were handled and disposed of according to protocol and regulatory guidelines. Having this information readily accessible in the study files ensures that both the PI and Sponsor can refer to it during audits, inspections, or other inquiries regarding the study's conduct. It helps in maintaining accountability and transparency throughout the research process. This aligns with good clinical practice as it supports the integrity of study data and adherence to ethical standards in research. In contrast, while filing this documentation in the sponsor's central files, the FDA submission package, or the subject's medical records may appear important, these options do not provide the same level of direct accessibility and relevance to the specific study's conduct and oversight as the combined study files of the PI and Sponsor do.