文档介绍：ICH 三方协调指导标准 E6 ICH GCP指导标准
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、统计和汇报设计人类对象参与试验国际性伦理和科学质量标准。遵照这一标准为保护对象权利、安全性和健康，为和源于赫尔辛基宣言标准保持一致和临床试验数据可信性提供了公众确保。
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指导标准目标是为欧盟、日本和美国提供统一标准，以促进这些管理当局在其权限内相互接收临床数据。
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).
本指导标准发展考虑了欧盟、日本、美国，和澳大利亚、加拿大、北欧国家和世界卫生组织（WHO）现行GCP。
This guideline should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities.
在产生计划提交给管理当局临床数据时应该遵照本指导标准。
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.
本指导标准中确立标准也可应用于可能影响人类对象安全和健康其它临床研究。
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 be