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

According to ICH guidelines, how long must an IRB/IEC keep correspondence after a clinical trial's completion?

1. 1 year

2. 3 years

3. 5 years

4. Indefinitely

The correct answer is: 3 years

Under ICH guidelines, the requirement for how long an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) must retain correspondence after the completion of a clinical trial is specified as at least three years. This timeframe ensures that there is adequate documentation of the review process and decisions made during the trial, which is essential for regulatory compliance, accountability, and historical reference in the context of clinical research. The three-year period aligns with the notion that significant correspondence related to the ethical aspects of a study, including approvals, amendments, and participant safety, must be accessible for review and potential audits. It allows for sufficient retention of important documentation that may be required for post-trial inquiries or future studies. This retention period also considers the possibility of any litigation or ethical scrutiny that might arise after a study concludes. This guideline emphasizes the importance of maintaining transparency and the integrity of the research process while striking a balance between efficient record-keeping and the practicalities of document storage.