ICH-GCP中英文对照(完整).pdf

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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 b

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