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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 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

1. 术语

1.1 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 product and an adverse event is at least a reasonable

possibility, i.e. the relationship cannot be ruled out.

在一个新的药品或药品的新用途在批准之前的临床实践，尤其是治疗剂量尚未确定前，ADR是指与药物任何剂量有关的所有有害的和非意求的反应都应被考虑为药物不良反应。该术语用于药品是指在药品与不良反应之间的因果关系至少有一个合理的可能性，即不能排除这种关系。

Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

对已上市药品，ADR指人对用于预防、诊断或治疗疾病或改善生理功能的药物在常用剂量出现的有害和非意求反应（参见ICH临床安全性数据管理指导原则：快速报告的定义和标准）。

1.2 Adverse Event (AE) 不良事件（AE）

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

在用药病人或临床研究对象中发生的任何不幸医疗事件，他不一定要与治疗有因果关系。因此，一个不良事件（AE）可以是与使用（研究）药物在时间上相关的任何不利的和非意求的征兆（包括异常的实验室发现）、症状或疾病，而不管其是否与药物有关（参见ICH临床安全性数据管理指导原则：快速报告的定义和标准）。

1.3 Amendment (to the protocol) 修改（试验方案）

See Protocol Amendment.

见试验方案修改

1.4 Applicable Regulatory Requirement(s) 适用的管理要求

Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products. 有关实施试验用药品临床试验的任何法律和法规。

1.5 Approval (in relation to Institutional Review Boards) 批准（机构审评委员会）

The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements.

IRB表示赞成的决定：指对一项临床试验已经进行审评，并可在IRB、研究机构、GCP和适用管理要

求的约束下由研究机构方实施。

1.6 Audit稽查

A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

对试验相关活动和文件进行系统和独立的监察，以判定试验的实施和数据的记录、分析与报告是否符合试验方案、申办者的标准操作程序（SOP）、临床试验管理规范（GCP）以及适用的管理要求。

1.7 Audit Certificate稽查证书

A declaration of confirmation by the auditor that an audit has taken place.

稽查员确认已进行稽查的声明。

1.8 Audit Report稽查报告

A written evaluation by the sponsor's auditor of the results of the audit. 申办者方稽查关于稽查结果的书面评价

1.9 Audit Trail稽查轨迹

Documentation that allows reconstruction of the course of events. 允许重复出现事件过程的文件。

1.10 Blinding/Masking设盲

A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s).

一种使试验的一个或几个部分的人员不知道治疗分配的程序。单盲通常指对象不知道；双盲通常指对象、研究人员、监察员以及在某些情况下数据分析人员也不知道治疗分配。

1.11 Case Report Form (CRF) 病例报告表（CRF）

A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.

设计用来记录试验方案要求向申办者报告的有关每一例对象的全部信息的印刷的、光学的或电子的文件。