ICH-GCP中英文对照（完整） - 图文

件）。

1.24 Good Clinical Practice (GCP) 临床试验管理规范（GCP）

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.

是临床试验设计、实施、执行、监察、稽查、记录、分析和报告的标准，它为数据和所报告结果的可信性和准确性提供了保证，并保护试验对象的权利、完整性和机密性。

1.25 Independent Data-Monitoring Committee (IDMC) (Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee)

独立的数据监察委员会（IDMC）（数据和安全监察委员会，监察委员会，数据监察委员会）

An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial. 由申办者设立一个独立的数据监察委员会，它定期对研究进展、安全性数据和有效性终点进行评估，向申办者建议是否继续、调整或停止试验。

1.26 Impartial Witness 公平的见证人

A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.

独立与临床试验、不受与试验有关人员的不公正影响的个人。如果对象或对象的合法接受代表人不能阅读，他/她将参与知情同意过程，并向对象阅读提供给她们的知情同意书和其他书面资料。

1.27 Independent Ethics Committee (IEC) 独立的伦理委员会（IEC）

An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving / providing favourable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.

一个由医学专业人员和非医学专业人员组成的独立机构（研究机构的、地区的、国家的或超国家的审评机构或委员会），其职责是保证参加试验对象的权益、安全性和健康；并通过对试验方案、研究人员、设

施以及用于获得和记录试验对象知情同意的方法和材料的合理性进行审评和批准/提供起促进作用的意见以对这种保护提供公众保证

The legal status, composition, function, operations and regulatory requirements pertaining to Independent Ethics Committees may differ among countries, but should allow the Independent Ethics Committee to act in agreement with GCP as described in this guideline.

在不同的国家，独立的伦理委员会的法律地位、组成、职责、操作和适用的管理要求可能不用，但是应当如本指导原则所述，允许独立的伦理委员会按GCP进行工作。

1.28 Informed Consent 知情同意

A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.

一个对象在被告知与其作出决定有关的所有试验信息后，资源确认他或她参加一个特定试验的意愿过程。知情同意采用书面的、签字并注明日期的知情同意书。

1.29 Inspection 视察

The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organization’s (CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies).

管理当局在试验单位、申办者和/或合同研究组织或管理当局认为何时的其他机构对其认为与临床试验有关的文件、设备、记录和其他资源进行的官方审查的活动。

1.30 Institution (medical) （医学）研究机构

Any public or private entity or agency or medical or dental facility where clinical trials are conducted. 实施临床试验任何或私人的实体、代理机构、医学或齿科设施。

1.31 Institutional Review Board (IRB) 机构审评委员会（IRB）

An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects. 由医学、科学和非科学成员组成的一个独立机构，其职责是通过对试验方案及其修订本，获得受试对象

知情同意所用的方法和资料进行审评、批准和继续审评，确保一项试验的受试对象的权利、安全和健康得到保护。

1.32 Interim Clinical Trial/Study Report 临床试验/研究中期报告

A report of intermediate results and their evaluation based on analyses performed during the course of a trial. 根据试验进行过程中所做的分析写出的中期结果和评价的报告

1.33 Investigational Product 试验用药品

A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.

一种在临床试验中供试验的或作为对照的活性成分或安慰剂的药物制剂。包括一个已上市药品以不同于所批准的方式适用或组合（制剂或包装），或用于一个未经批准的适应证，或用于收集一个已批准用法的更多资料。

1.34 Investigator 研究者

A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. See also Subinvestigator.

负责在一个试验单位实施临床试验的人。如果在一个试验单位是由一组人员实施试验，研究者指这个组的负责人，也称为主要研究者。见次级研究人员。

1.35 Investigator / Institution 研究者/研究机构

An expression meaning \investigator and/or institution, where required by the applicable regulatory requirements\

表示“符合适用管理要求的研究者和/或研究机构”

1.36 Investigator's Brochure 研究者手册

A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects (see 7. Investigator’s Brochure). 与试验药品在人类对象中的研究有关的临床和非临床资料的汇编（见7.研究者手册）

1.37 Legally Acceptable Representative 法律上可接受的代表

An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial.

在适用法律下被授权代表一位未来的对象同意参加临床试验的个人，或司法人员或其他机关。

1.38 Monitoring 监察

The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

监督一个临床试验的进展，保证临床试验按照试验方案、标准操作程序（SOP）、临床试验管理规范（GCP）和适用的管理要求实施、记录和报告的活动。

1.39 Monitoring Report 监察报告

A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs.

监察员在每一次现场访问和/或其他与试验有关的交流后，根据申办者的SOP写给申办者的书面报告。

1.40 Multicentre Trial 多中心试验

A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator.

按照一个试验方案，在一个以上试验单位实施，因此由一名以上研究者完成的临床试验。

1.41 Nonclinical Study 非临床试验

Biomedical studies not performed on human subjects. 不是在人类对象进行的生物医学研究。

1.42 Opinion (in relation to Independent Ethics Committee) 意见（与独立的伦理委员会相关）

The judgement and/or the advice provided by an Independent Ethics Committee (IEC).

由独立的伦理委员会（IEC）给出的评价和/或建议

1.43 Original Medical Record 原始医学记录

See Source Documents. 见源文件

1.44 Protocol 试验方案

A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments.

一个阐明试验的目的、设计、方法学、统计学考虑和组织的文件。试验方案通常也给出试验的背景和理论基础，但者这可以写在与方案有关的其他参考文件中。在ICH指导原则中，试验方案这一术语指试验方案和方案的修改。

1.45 Protocol Amendment 试验方案的修改

A written description of a change(s) to or formal clarification of a protocol. 对试验方案的改变或澄清的书面描述。

1.46 Quality Assurance (QA) 质量保证（QA）

All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).

为保证试验的进行和数据产生、记录以及报告都符合临床试验管理规范（GCP）和适用管理要求所建立的有计划的系统活动。

1.47 Quality Control (QC) 质量控制（QC）

The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.

在质量保证系统内所采取的操作技术和活动，以查证与试验相关的活动都符合质量要求。