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1、精选优质文档-倾情为你奉上 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
2、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
3、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
4、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（WH
5、O）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 saf
6、ety 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. GLOSSARY1. 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 an
7、d 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 can
8、not 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, di
9、agnosis, 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
10、（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 l
11、aboratory 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
12、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 t
13、he 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
14、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 t
15、rial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsors 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
16、、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 sponsors 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 t
17、hat 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 sub
18、ject(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
19、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。1.12 Clinical Trial/Study 临床试验/研究Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects
20、of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and c
21、linical study are synonymous.在人类对象进行的任何意在发现或证实一种试验用药品的临床、药理学和/或其他药效学作用；和/或确定一种试验用药品的任何不良反应；和/或研究一种试验用药品的吸收、分布、代谢和排泄，以确定药物的安全性和/或有效性的研究。术语临床试验和临床研究同义。1.13 Clinical Trial/Study Report 临床试验/研究报告A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in hum
22、an subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report (see the ICH Guideline for Structure and Content of Clinical Study Reports). 在人类对象进行的任何治疗、预防或诊断剂的试验/研究的书面描述。临床和统计描述、陈述和分析全部列入该单份报告（见ICH临床研究报告的结构和内容指导原则）。1.14 Comparat
23、or (Product) 对照（药物）An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial. 临床试验中用做对照的试验用药品或市售药物（即阳性对照）或安慰剂。1.15 Compliance (in relation to trials) 依从性（关于试验的）Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requi
24、rements, and the applicable regulatory requirements. 遵循与试验有关的所有要求、临床试验管理规范（GCP）要求和适用的管理要求。1.16 Confidentiality 保密性Prevention of disclosure, to other than authorized individuals, of a sponsors proprietary information or of a subjects identity. 不得向未经授权的个人泄漏申办者所有的资料或对象的身份。1.17 Contract合同A written, date
25、d, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract. 在两个或几个有关方之间的一份书面的、有日期和签字的协议，其中陈述了关于工作和责任和分派的安排，以及关于财务问题的安排
26、。试验方案可以作为合同的基础。1.18 Coordinating Committee协调委员会A committee that a sponsor may organize to coordinate the conduct of a multicentre trial. 申办者组织的协调实施多中心试验的委员会。1.19 Coordinating Investigator协调研究者An investigator assigned the responsibility for the coordination of investigators at different centres parti
27、cipating in a multicentre trial. 被指定负责协调参加一项多中心试验的各中心研究者工作的一名研究者。1.20 Contract Research Organization (CRO) 合同研究组织A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsors trial-related duties and functions. 与申办者订立契约完成一个或多个有关申办者方的试验任务和
28、功能的个人或组织（商业性的，学术的或其他）。1.21 Direct Access 直接访问Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsors monitors and auditors) with direct access should tak
29、e all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects identities and sponsors proprietary information. 允许监察、分析、核对和复制任何对于评价临床试验有重要意义的记录和报告。直接访问的任何一方（如国内和国外的管理当局，申办者方的监察员和稽查员）应当受适用管理要求的缺书，采取一切合理的预防措施维护对象身份和申办者资料的保密性。
30、1.22 Documentation 文件All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken.
31、描述或记录试验的方法、实施和/或结果，影响试验的因素，以及采取的措施等的任何形式的记录（包括但不限于书面、电子、磁性和光学的记录，以及扫描、X射线和心电图）。1.23 Essential Documents 必需文件Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced (see 8. Essential Documents for the Conduct of a Clinical Trial).
32、 指各自和合在一起允许评价一个研究的执行情况和所得数据的质量文件（见8.实施临床试验的必需文件）。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 acc
33、urate, 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)
34、 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 st
35、op 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 subjects legally acce
36、ptable 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 revie
37、w 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 o
38、f 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
39、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
40、 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 t
41、rial, after having been informed of all aspects of the trial that are relevant to the subjects 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
42、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 sponsors and/or contract research or
43、ganizations (CROs) 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 clinica
44、l 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 i
45、n 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
46、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 o
47、r 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 a
48、n 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 r
49、esponsible 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 the investigator and/or institution, where required by the applicable regulatory requirements.