ICH E3 (Structure and Content of Clinical Study Reports)

ICH E3 is a guideline that outlines how to organize and present the results of a clinical trial in a detailed report. It ensures that reports are consistent, comprehensive, and transparent, allowing regulators, scientists, and healthcare professionals to evaluate the safety and effectiveness of a new treatment. The document specifies the structure, sections, and content that should be included, such as study design, methods, results, and conclusions, making it easier to understand and compare different studies. This standardization helps maintain high quality and reliability in clinical research documentation.