Which statement best describes IRB/IEC record retention duration?

• A. Retain records for at least 3 years after completion.
• B. Retain records indefinitely.
• C. Retain records for 6 months after completion.
• D. Retain records only during the trial.

Answer: (A)

IRB/IEC record retention duration is about how long regulatory records related to the study must be kept after the study ends to support oversight, audits, and any follow-up questions. The best choice is to retain essential documents for at least three years after completion of the trial. This timeframe aligns with ICH GCP guidance and common regulatory practice, ensuring that records are available for inspections, safety reviews, and any post-trial inquiries. Local laws or sponsor policies may require longer retention, but three years is the standard minimum in many settings. Retaining only during the trial isn’t enough because oversight and potential issues can arise after completion, and six months after completion is too short to satisfy typical regulatory review timelines. Keeping records indefinitely isn’t generally required by standard GCP guidance and can create unnecessary storage and privacy concerns.