ICHGCP中英文对照分析和总结.docx

ICH 三方协调指导原则 E6 ICH GCP 指导原则INTRODUCTION 前 言 Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. 临床试验管理规范（GCP）是设计、实施、记录和报告设计人类对象参加的试验国际性伦理和科学质量标准。遵循这一标准为保护对象的权利、安全性和健康，为与源于赫尔辛基宣言的原则保持一致以及临床试 验数据的可信性提供了公众保证。 The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. ICH-GCP 指导原则的目的是为欧盟、日本和美国提供统一的标准，以促进这些管理当局在其权限内相互接受临床数据。 The guideline was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the World Health Organization (WHO). 本指导原则的发展考虑了欧盟、日本、美国，以及澳大利亚、加拿大、北欧国家和世界卫生组织（WHO） 的现行 GCP。 This guideline should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities. 在产生打算提交给管理当局的临床数据时应当遵循本指导原则。 The principles established in this guideline may also be applied to other clinical investigations that may have an impact on the safety and well-being of human subjects. 本指导原则中确立的原则也可应用于可能影响人类对象安全和健康的其他临床研究。 1. GLOSSARY 术语 Adverse Drug Reaction (ADR) 药品不良反应（ADR） In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal relationship between a medicinal