SOCRA CCRP Practice Exam

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For how long must an IRB retain records according to 21 CFR 56?

1 year after completion of research
2 years after completion of research
3 years after completion of research
5 years after completion of research

The correct answer is: 3 years after completion of research

An IRB must retain records for a minimum of 3 years after the completion of research. This is in accordance with 21 CFR 56, which outlines the regulations for Institutional Review Boards (IRBs). This time frame allows the IRB to maintain the necessary documentation to demonstrate compliance with regulations and provide evidence of their review and oversight of the research. Options A, B, and D are incorrect because they do not meet the minimum requirement of 3 years. Option D may seem like the appropriate choice since it is the longest time frame, but it is important to note that IRBs must retain records for a minimum of 3 years, so this time frame is the baseline.