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

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

1. 1 year

2. 3 years

3. 5 years

4. 10 years

The correct answer is: 3 years

The correct duration for which an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) must keep correspondence after the completion of a clinical trial is three years. This guideline is consistent with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, which require that records related to the clinical trial, including correspondence, are maintained for a minimum of three years after the trial's completion. This period allows for proper oversight, potential audits, and ensures that there is adequate documentation available for review in the event of any questions or issues that arise post-trial. The decision to set this specific timeframe reflects a balance between the need for accountability in clinical research and the practical considerations of record-keeping for organizations involved in research. Other durations like one year, five years, or ten years either exceed or do not meet the stipulated requirements set by ICH guidelines, making three years the most appropriate choice. The focus on three years is particularly important, as it aligns with regulatory expectations and supports the integrity of the clinical research process.