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

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Prepare for the ACRP Certified Professional Exam with our comprehensive quiz. Elevate your clinical research skills with targeted flashcards and multiple-choice questions. Enhance your readiness with detailed explanations and insights for improved performance!

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According to ICH guidelines, how long must an IRB retain correspondence after trial completion?

  1. 1 Year

  2. 2 Years

  3. 3 Years

  4. 5 Years

The correct answer is: 3 Years

The correct answer is based on the guidelines provided by the International Council for Harmonisation (ICH) which state that an Institutional Review Board (IRB) must retain correspondence related to clinical trials for a minimum of three years after the completion of the trial. This retention period is set to ensure that there is a comprehensive record of the trial's compliance with ethical standards and regulatory requirements, allowing for adequate oversight and accountability. Retaining correspondence for three years allows the IRB to address any issues that may arise post-trial, such as inquiries into how the trial was conducted or concerns about participant safety and ethics. This timeframe aligns with the need for transparency and thoroughness in clinical research, enabling effective monitoring even after the trial has officially concluded. In contrast, other timeframes such as one year, two years, or five years do not meet the specific requirements outlined by ICH guidelines, which explicitly mandate the three-year retention period.