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

Where can ICH safety definitions be found?

1. ICH E2A

2. ICH E6

3. ICH E1

4. ICH E8

The correct answer is: ICH E2A

The ICH E2A guidelines, titled "Clinical Safety Data Management: Definitions and Standards for Expedited Reporting," specifically address definitions related to the safety of clinical trials. This guideline provides a framework aimed at ensuring that safety data is collected, managed, and reported consistently during the conduct of clinical trials. In ICH E2A, it outlines key safety-related terms and concepts that are fundamental for understanding clinical safety reporting. It also emphasizes the importance of clear definitions in maintaining high standards of patient safety during drug development processes. This approach facilitates communication and regulatory compliance across different jurisdictions, making it an essential reference for clinical trial sponsors, researchers, and regulatory authorities when discussing safety matters in clinical settings. Conversely, the other options, ICH E6, ICH E1, and ICH E8, focus on different aspects of clinical research such as Good Clinical Practice, pharmacovigilance, and general clinical trial design standards, respectively, and do not focus specifically on safety definitions.