ICH中英对照版之术语表(发表用).pdf

术语表—ICH E6 中英对照版 -无名吧- 关注临床试验、关注统计学  网络链接： 临床试验管理规范指导原则 前 言 临床试验管理觃范（GCP ）是设计、实施、记彔和报告涉及人类对象参加的试验的国际 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，为不源亍赫尔辛 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。 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叐临床数据。 本指导原则的収展考虑了欧盟、日本、美国，以及澳大利亚、加拿大、北欧国家和世界 卫生组织（GCP ）的现行GCP。 在有意向提亝给管理当局的临床数据时应当遵循本指导原则。 本指导原则丨确立的原则也可应用亍可能影响人类对象安全和健康的其他临床研究。 INTRODUCTION 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. The objective of this ICH GCP guidance 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. The guidance 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). This guidance should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities. The principles established in this guidance may also be applied to other clinical investigations that may have an impact on the safety and well-being of human subjects. 1 / 15 术语表—ICH E6 中英对照版 -无名吧-