Good Clinical Practice (GCP) Practice Exam

What is the minimum retention period for relevant IRB records after the completion of a trial?

1. 1 year

2. 3 years

3. 5 years

4. 10 years

The correct answer is: 3 years

The correct answer regarding the minimum retention period for relevant Institutional Review Board (IRB) records after the completion of a trial is three years. This duration is aligned with regulatory requirements established by the U.S. Department of Health and Human Services (HHS) in 45 CFR Part 46, which governs the protection of human subjects. The three-year retention period ensures that there is adequate time for any potential regulatory audits, inquiries, or issues that may arise related to the trial's conduct or ethical considerations. These records are critical for maintaining transparency, accountability, and compliance with ethical standards in research involving human participants. Additionally, retaining these records allows for tracking of compliance with IRB approval and monitoring the safety and welfare of trial subjects up to a designated timeframe post-study. Other options suggest shorter or longer retention times that do not meet the regulatory standard mandated by HHS, emphasizing the importance of adhering to established guidelines in clinical research.