《ICH-GCP》临床试验管理规范E6（R2）中英双语版语料

　　原标题：《ICH-GCP》临床试验管理规范E6（R2）中英双语版语料

　　INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE ICH E6(R2)

　　临床试验管理规范指导原则

　　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受试者的权利、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.

　　在有意向提交给药政管理当局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。

　　Since the development of the ICH GCP Guideline, the scale, complexity, and cost of clinical trials have increased. Evolutions in technology and risk management processes offer new opportunities to increase efficiency and focus on relevant activities. When the original ICH E6(R1) text was prepared, clinical trials were performed in a largely paper-based process. Advances in use of electronic data recording and reporting facilitate implementation of other approaches. For example, centralized monitoring can now offer a greater advantage, to a broader range of trials than is suggested in the original text. Therefore, this guideline has been amended to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results. Standards regarding electronic records and essential documents intended to increase clinical trial quality and efficiency have also been updated.

　　自从ICH GCP发展以来，临床试验的规模、复杂性和成本在不断增加。技术和风险管理程序的创新，为提高临床试验效率和相关活动带来了新的发展机遇。当ICH E6（R1）指南在制定时，大部分临床试验还是在用纸质流程进行操作。电子数据记录和报告的发展与进步促进了新的临床试验方法的产生。例如，如今大规模的临床试验，中心化监察比传统模式更有优势。因此，对本指南进行了修订，以鼓励在临床试验设计、实施、监督、记录和报告中使用更先进、有效的方法。同时，继续确保受试者得到保护，试验结果可靠。更新了电子记录标准和必要文件，旨在提高临床试验的质量和效率。

　　This guideline should be read in conjunction with other ICH guidelines relevant to the conduct of clinical trials (e.g., E2A (clinical safety data management), E3 (clinical study reporting), E7 (geriatric populations), E8 (general considerations for clinical trials), E9 (statistical principles), and E11 (pediatric populations)).

　　本指南应当结合其他临床试验实施相关的ICH指南一起阅读，如E2A（临床安全性数据管理）、E3（临床研究报告）、E7（老年人）、E8（临床试验总则）、E9（统计原则）和E11（儿科）。

　　This ICH GCP Guideline Integrated Addendum provides a unified standard for the European Union, Japan, the United States, Canada, and Switzerland to facilitate the mutual acceptance of data from clinical trials by the regulatory authorities in these jurisdictions. In the event of any conflict between the E6(R1) text and the E6(R2) addendum text, the E6(R2) addendum text should take priority.

　　本ICH GCP完整增补版指南为欧盟、日本、美国、加拿大和瑞士提供了统一标准，以促进这些管理当局在其权限内相互认可彼此提供的临床数据。当E6（R1）内容和E6（R2）增补内容出现冲突时，以E6（R2）内容为准。

　　1.GLOSSARY

　　1.术语

　　1.1 Adverse Drug Reaction (ADR)

　　1.1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预想的反应都应被考虑为药品不良反应。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预想的反应(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)

　　1.2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).

　　正在用药病人或临床研究受试者中发生的任何不良医学事件，但不一定与治疗有因果关系。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预想的征兆(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)

　　1.3修改(试验方案)

　　See Protocol Amendment.

　　见试验方案修改。

　　1.4 Applicable Regulatory Requirement(s)

　　1.4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)

　　1.5批准(关于机构审评委员会)

　　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和适用管理要求的前提下由研究机构方实施。

　　1.6 Audit

　　1.6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检查，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

　　1.7稽查证书

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

　　稽查员确认已进行过稽查的声明。

　　1.8 Audit Report

　　1.8稽查报告

　　A written evaluation by the sponsor’s auditor of the results of the audit.

　　由申办者方稽查员出具的关于稽查结果的书面评价。

　　1.9 Audit Trail

　　1.9稽查轨迹

　　Documentation that allows reconstruction of the course of events.

　　可重现整个稽查事件过程的对应文件。

　　1.10 Blinding/Masking

　　1.10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), investigators), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s).

　　临床试验过程中使一方或多方人员不知道受试者治疗分配的程序。单盲指受试者不知；双盲指受试者、研究者、监查员以及在某些情况下数据分析者均不知治疗分配。

　　1.11 Case Report Form (CRF)

　　1.11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.

　　按试验方案所规定设计的一种印刷的、光学的或电子的文件，用来记录每一名受试者在研究过程中的全部信息报告给申办者。

　　1.12 Clinical Trial/Study

　　1.12临床试验研究

　　Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects 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 clinical 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

　　1.13临床试验/研究报告

　　A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human 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 Comparator (Product)

　　1.14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(即活性对照)或安慰剂。

　　1.15 Compliance (in relation to trials)

　　1.15依从性(关于试验的)

　　Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, 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)要求和相应的药政管理要求。

　　1.16 Confidentiality

　　1.16保密性

　　Prevention of disclosure, to other than authorized individuals, of a sponsor’s proprietary information or of a subject’s identity.

　　不得向未经授权的个人泄露申办者所有的资料或受试者的身份。

　　1.17 Contract

　　1.17合同

　　A written, dated, 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.

　　在两方或多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的委托和分派的安排，以及相关财务问题的安排。试验方案可以作为合同的基础。

　　1.18 Coordinating Committee

　　1.18协调委员会

　　A committee that a sponsor may organize to coordinate the conduct of a multicentre trial.

　　由申办者组织的协调实施多中心试验的委员会。

　　1.19 Coordinating Investigator

　　1.19协调研究者

　　An investigator assigned the responsibility for the coordination of investigators at different centres participating in a multicentre trial.

　　在多中心临床试验中负责协调参加各中心研究者工作的一名研究者。

　　1.20 Contract Research Organization (CRO)

　　1.20合同研究组织(CRO)

　　A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions.

　　与申办者订立契约，受委托完成其执行临床试验中的某些任务和工作的个人或组织(商业性的，学术的或其他)。

　　1.21 Direct Access

　　1.21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, sponsor's monitors and auditors) with direct access should take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects’ identities and sponsor’s proprietary information.

　　允许检查、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与报告。直接访问的任何一方(如国内和国外的管理当局，申办者方的监查员和稽查员)应当受适用管理要求约束，采取一切合理的预防措施维护受试者身份和申办者资料的保密性。

　　1.22 Documentation

　　1.22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.

　　用于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

　　1.23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).

　　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)

　　1.24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、监查、稽查、记录、分析和报告的标准，目的确保数据和所报告结果的可信性和准确性，并确保受试者的权利、完整性和机密性得到保护。

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

　　1.25独立的数据监查委员会(IDMC)(数据和安全监查委员会，监查委员会，数据监查委员会)

　　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.

　　由申办者方设立一个独立的数据监查委员会，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

　　1.26公正见证人

　　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.

　　如果受试者或其法定代理人不能阅读，公正见证人将参与知情同意过程，并向受试者阅读提供给他们的知情同意书和其他书面资料，作为独立于临床试验的个人，其不受与试验有关人员的不公正影响。

　　1.27 Independent Ethics Committee (IEC)

　　1.27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)，其职责是确保受试者的权益、安全性和健康得到保护；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同，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

　　1.28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.

　　指向受试者告知一项试验的各方面情况后，受试者自愿确认其同意参加该项临床试验的过程。该过程须以书面的、签名和注明日期的知情同意书作为文件证明。

　　1.29 Inspection

　　1.29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).

　　药政管理部门对一项临床试验的有关文件、设备、记录和其他方面进行官方审阅，视察可以在试验单位、申办者和/或合同研究组织或管理当局认为合适的其他机构进行。

　　1.30 Institution (medical)

　　1.30(医学)研究单位

　　Any public or private entity or agency or medical or dental facility where clinical trials are conducted.

　　实施临床试验的任何公共或私人的实体、代理机构、医学或牙科设施。

　　1.31 Institutional Review Board (IRB)

　　1.31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，获得受试者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者的权利、安全和健康得到保护。

　　1.32 Interim Clinical Trial/Study Report

　　1.32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作的分析写出的中期结果和评价的报告。

　　1.33 Investigational Product

　　1.33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使用或组合(制剂或包装)，或用于一个未经批准的适应症，或用于收集一个已批准用法的更多资料。

　　1.34 Investigator

　　1.34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 Sub-investigator.

　　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

　　1.35研究者/研究机构

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

　　表示“符合适用药政管理要求的研究者和/或研究机构”。

　　1.36 Investigator’s Brochure

　　1.36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).

　　是有关试验药品在进行人体试验室已有的该药品的临床和非临床资料的汇编（见7.研究者手册）。

　　1.37 Legally Acceptable Representative

　　1.37法定监护人

　　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，被授权可代表受试者同意参加临床试验的个人，或司法人员或其他主体。

　　1.38 Monitoring

　　1.38监查

　　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)和相应的药政管理要求实施、记录和报告的活动。

　　1.39 Monitoring Report

　　1.39监查报告

　　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.

　　监查员在结束每一次现场访问和/或完成其他与试验有关的交流后，根据申办者的SOP完成的一份提交给申办者的书面报告。

　　1.40 Multicentre Trial

　　1.40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.

　　按照同一个试验方案，在一个以上试验单位实施，由多名以上研究者共同完成的临床试验。

　　1.41 Nonclinical Study

　　1.41非临床试验

　　Biomedical studies not performed on human subjects.

　　在人体之外进行的生物医学研究。

　　1.42 Opinion (in relation to Independent Ethics Committee)

　　1.42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

　　1.43原始医学记录

　　See Source Documents.

　　见源文件。

　　1.44 Protocol

　　1.44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.

　　一个阐明试验目的、设计、方法学、统计学考虑和组织的文件。试验方案通常包括试验的背景和理论基础，但这也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

　　1.45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正式澄清的书面描述。

　　1.46 Quality Assurance (QA)

　　1.46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)

　　1.47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，以查证与试验有关的活动都符合质量要求。

　　1.48 Randomization

　　1.48随机化

　　The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.

　　为了减少偏倚，采用机遇决定分配的原理将受试者分配到治疗组或对照组的过程。

　　1.49 Regulatory Authorities

　　1.49管理当局

　　Bodies having the power to regulate. In the ICH GCP Guideline the expression Regulatory Authorities includes the authorities that review submitted clinical data and those that conduct inspections (see 1.29). These bodies are sometimes referred to as competent authorities.

　　有权进行管理的机构。在ICH GCP指导原则中，管理当局一词包括审评所提交的临床数据和实施视察的机构(见1.29)。这些机构有时指主管当局。

　　1.50 Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR)

　　1.50严重不良事件(SAE)或严重药品不良反应

　　Any untoward medical occurrence that at any dose:

　　在任何剂量下发生的任何不利医学事件：

　　-results in death,

　　导致死亡

　　-is life-threatening,

　　危及生命

　　-requires inpatient hospitalization or prolongation of existing hospitalization,

　　需要住院治疗或延长住院时间

　　-results in persistent or significant disability/incapacity, or

　　导致永久或严重的残疾/能力丧失，或

　　-is a congenital anomaly/birth defect

　　先天性异常/出生缺陷。

　　(see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

　　(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)

　　1.51 Source Data

　　1.51源数据

　　All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).

　　临床试验中的临床发现、观察或其他活动的原始记录及其可靠副本中的全部资料，它们对于重建和评价试验是必要的。源数据包含在源文件中(原始记录或可靠副本)。

　　1.52 Source Documents

　　1.52源文件

　　Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial).

　　原始文件、数据和记录(如医院记录，临床和办公室图表，实验室笔记，备忘录，受试者日记卡或评价表，药房发药记录，自动仪器的记录数据，在核对后作为准确副本的可靠复印件或抄件，显微胶片，摄影负片，缩微胶卷或磁介质，X线，受试者文件，以及保存在药房、实验室和与参与临床试验的医学技术科室中的记录)。

　　1.53 Sponsor

　　1.53申办者

　　An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.

　　发起一项临床试验的，并对该试验的管理和财务负责的个人、公司、机构或组织。

　　1.54 Sponsor-Investigator

　　1.54申办者-研究者

　　An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.

　　单独或与其他人一起，发起并实施一个临床试验的个人。在他(们)的直接指示下，给对象服用、发给对象或由对象使用试验用药品。该术语并不包括除了个人以外的任何人(如不包括一个公司和一个机构)。一个申办者-研究者的义务包括一个申办者和一个研究者两者的义务。

　　1.55 Standard Operating Procedures (SOPs)

　　1.55标准操作程序（SOP）

　　Detailed, written instructions to achieve uniformity of the performance of a specific function.

　　为达到均一性完成一个特定职责制订的详细书面说明。

　　1.56 Sub-investigator

　　1.56次级研究人员

　　Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). See also Investigator.

　　在一个试验单位，在主要研究者指定和监督下的临床试验组中完成与试验有关的重要程序和/或作出与有关试验的重大决定的成员(如同事，住院医生，特别是研究生)。见研究者。

　　1.57 Subject/Trial Subject

　　1.57对象/试验对象

　　An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.

　　参加一个临床试验作为试验药品的接受者或作为对照的个人。

　　1.58 Subject Identification Code

　　1.58对象识别编码

　　A unique identifier assigned by the investigator to each trial subject to protect the subjects identity and used in lieu of the subject’s name when the investigator reports adverse events and/or other trial related data.

　　研究者为每一名受试者分配的一个独特识别号码，以保护对象的身份并在研究者报告不良事件和其他与试验有关数据时用来代替受试者的姓名。

　　1.59 Trial Site

　　1.59试验单位

　　The location(s) where trial-related activities are actually conducted.

　　进行与临床试验有关活动的场所。

　　1.60 Unexpected Adverse Drug Reaction

　　1.60非预期的药品不良反应

　　An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product) (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

　　一种不良反应，其性质或严重程度与现有的产品资料(如一种未批准的试验用药品的研究者手册，或包装插入页/一个已经批准药物的产品性能摘要)不符的不良反应(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)。

　　1.61 Vulnerable Subjects

　　1.61弱势对象

　　Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

　　指受到不正当的影响而成为临床试验志愿者的人，他们可能由于期望（无论正当与否）参加试验而伴随的利益，或者拒绝参加会受到等级中资深成员的报复。有等级结构的团体的成员，如医学、药学、牙科和护理专业的学生，附属医院和实验室人员，制药公司的雇员，军人，以及被监禁的人。其他弱势对象包括无可救药疾病的病人，住在福利院中的人，失业者或穷人，处于危急状况的病人，少数民族，无家可归者，流浪者，难民，未成年者，和那些无能力给出知情同意的人。

　　1.62 Well-being (of the trial subjects)

　　1.62(试验对象的)健康

　　The physical and mental integrity of the subjects participating in a clinical trial.

　　参加临床试验受试者的身体和精神的完整性。

　　ADDENDUM

　　附录

　　1.63 Certified Copy

　　1.63核证副本

　　A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure, as the original.

　　经核实(如注明日期的签字或通过可验证的程序产生的)，与原始记录有相同信息（包括描述数据的上下文、内容和结构）的副本（无论使用何种媒介类型）。

　　1.64 Monitoring Plan

　　1.64监查计划

　　A document that describes the strategy, methods,responsibilities, and requirements for monitoring the trial.

　　一份描述试验监查策略、方法、职责和要求的文件。

　　1.65 Validation of Computerized Systems

　　1.65计算机系统验证

　　A process of establishing and documenting that the specified requirements of a computerized system can be consistently fulfilled from design until decommissioning of the system or transition to a new system. The approach to validation should be based on a risk assessment that takes into consideration the intended use of the system and the potential of the system to affect human subject protection and reliability of trial results.

　　指建立并记录计算机系统符合规定要求的过程，该计算机系统需要持续满足设计要求，至系统退役或过渡至一个新的系统中。验证方法需要基于风险评估，考虑系统的预期用途和系统潜在影响受试者保护和试验结果可靠性的可能。

　　2. THE PRINCIPLES OF ICH GCP

　　2.ICH GCP的原则

　　2.1 Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).

　　2.1 临床试验的实施应符合源自赫尔辛基宣言的伦理原则，与GCP和适用管理要求一致。

　　2.2 Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.

　　2.2 在开始一项试验之前，应当权衡该临床试验对于个体受试者和社会的可预见的风险、不方便和预期的受益。只有当预期的受益大于风险时，才可以开始和继续这项临床试验。

　　2.3 The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.

　　2.3 受试者的权利、安全和健康是最重要的考虑，应当高于对科学和社会的利益的考虑。

　　2.4 The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.

　　2.4 应该有足够的关于试验用药品的非临床和临床资料提供，以支持所计划进行的临床试验。

　　2.5 Clinical trials should be scientifically sound, and described in a clear, detailed protocol.

　　2.5 进行药物临床试验必须有充分的科学依据，应在试验方案中明确、详细地描述。

　　2.6 A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion.

　　2.6 临床试验的实施应当遵循事先已经得到研究机构审查委员会(IRB)/独立的伦理委员会(IEC)批准/赞成的试验方案。

　　2.7 The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.

　　2.7 一名合格医生或合格牙医的职责永远是给予对象医疗保健，代表对象作出医学决定。

　　2.8 Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).

　　2.8 参与实施临床试验的每一个人应当在受教育、培训和经验方面都有资格完成他或她的预期任务。

　　2.9 Freely given informed consent should be obtained from every subject prior to clinical trial participation.

　　2.9在参加临床试验前,应获得每一个受试者主动给出的知情同意。

　　2.10 All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.

　　2.10 所有临床试验资料应被妥善的记录、处理和保存,以便确保相关资料能进行准确报告、解释和核对。

　　ADDENDUM

　　附录

　　This principle applies to all records referenced in this guideline, irrespective of the type of media used.

　　这个原则适用于本指南中的所有记录，不论使用何种类型媒介。

　　2.11 The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).

　　2.11 确保用于鉴别受试者身份的记录的保密性应当得到保护，根据相应的保密规定。

　　2.12 Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.

　　2.12 试验用药品应当按照适用的药品生产质量管理规范(GMP)生产、处理和储存。试验用药品应按照已批准的方案使用。

　　2.13 Systems with procedures that assure the quality of every aspect of the trial should be implemented.

　　2.13 应当建立相应的程序系统来保证试验各方面质量。

　　ADDENDUM

　　附录

　　Aspects of the trial that are essential to ensure human subject protection and reliability of trial results should be the focus of such systems.

　　系统关注的重点应在确保受试者的保护和试验结果的可靠性这些必不可少方面。

　　3 INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE(IRB/IEC)

　　3.机构审评委员会/独立的伦理委员会(IRB/IEC)

　　3.1 Responsibilities

　　3.1职责

　　3.1.1 An IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid to trials that may include vulnerable subjects.

　　3.1.1 IRB/IEC应当保护所有受试者的权利、安全和健康。应当特别注意那些可能有弱势对象参与的试验。

　　3.1.2 The IRB/IEC should obtain the following documents:

　　3.1.2IRB/IEC应当得到以下文件：

　　trial protocol(s)/amendment(s),written informed consent form(s) and consent form updates that the investigator proposes for use in the trial, subject recruitment procedures (e.g.,advertisements),written information to be provided to subjects,Investigator’s Brochure (IB), available safety information, information about payments and compensation available to subjects, the investigator's current curriculum vitae and/or other documentation evidencing qualifications, and any other documents that the IRB/IEC may need to fulfil its responsibilities.

　　试验方案/修改，研究人员申请用于试验的书面知情同意书及其更新件，受试者招募程序(如广告)，提供给受试者的书面资料，研究者手册(IB)，可得到的安全性资料，受试者可获得的付款和补偿，研究人员的最新简历和/或其他证明其资格的文件，以及IRB/IEC履行其职责所需要的任何其他文件。

　　The IRB/IEC should review a proposed clinical trial within a reasonable time and document its views in writing, clearly identifying the trial, the documents reviewed and the dates for the following:

　　IRB/IEC应当在合理的时限内审查所提议的临床研究，提供书面审评意见，明确地确认试验、所审评的文件和日期如下：

　　-approval/favourable opinion;

　　批准/赞成意见；

　　-modifications required prior to its approval/favourable opinion;

　　在批准/赞成之前所需要的修改；

　　-disapproval / negative opinion; and

　　不批准/负面的意见；和

　　-termination/suspension of any prior approval/favourable opinion.

　　终止/暂停先前的批准/赞成意见。

　　3.1.3 The IRB/IEC should consider the qualifications of the investigator for the proposed trial, as documented by a current curriculum vitae and/or by any other relevant documentation the IRB/IEC requests.

　　3.1.3IRB//IEC应当参照研究人员最新简历和/或IRB/IEC要求的其他相关文件考虑参加所提议试验的研究人员的资格。

　　3.1.4 The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects, but at least once per year.

　　3.1.4IRB/IEC应当根据人类对象的危险度，间隔一定时间对正在进行的试验进行持续的审评，至少每年一次。

　　3.1.5 The IRB/IEC may request more information than is outlined in paragraph 4.8.10 be given to subjects when, in the judgement of the IRB/IEC, the additional information would add meaningfully to the protection of the rights, safety and/or well-being of the subjects.

　　3.1.5在IRB/IEC审评中，IRB/IEC可能需要比4.8.10段概述中提供给受试者更多的资料，这些资料在对于增加保护对象的权利、安全和/或健康有意义。

　　3.1.6 When a non-therapeutic trial is to be carried out with the consent of the subject's legally acceptable representative (see 4.8.12, 4.8.14), the IRB/IEC should determine that the proposed protocol and/or other document(s) adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such trials.

　　3.1.6当一个将进行的非治疗试验是由受试者的可接受的合法代表给出知情同意时(见4.8.12，4.8.14)，IRB/IEC应当确定，所建议的方案和/或其他文件已经充分说明了相关的伦理学考虑，并符合这一类试验的适用管理要求。

　　3.1.7 Where the protocol indicates that prior consent of the trial subject or the subject's legally acceptable representative is not possible (see 4.8.15), the IRB/IEC should determine that the proposed protocol and/or other document(s) adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such trials (i.e., in emergency situations).

　　3.1.7试验方案指出试验受试者或其合法的可接受的代表的不可能先给出知情同意时(见4.8.15)，IRB/IEC应当确定所提议的方案和/或其他文件充分说明了相关的伦理学考虑，并符合这一类试验的适用管理要求。

　　3.1.8 The IRB/IEC should review both the amount and method of payment to subjects to assure that neither presents problems of coercion or undue influence on the trial subjects. Payments to a subject should be prorated and not wholly contingent on completion of the trial by the subject.

　　3.1.8IRB/IEC应当审评支付给受试者款项的数量和方式，以确信没有对试验对象的胁迫问题或不正当影响。给受试这的支付应当按比例分配，而不是完全以受试者完成试验而定。

　　3.1.9 The IRB/IEC should ensure that information regarding payment to subjects, including the methods, amounts, and schedule of payment to trial subjects, is set forth in the written informed consent form and any other written information to be provided to subjects. The way payment will be prorated should be specified.

　　3.1.9IRB/IEC应当保证，关于支付给受试者的资料，包括支付方式、数量和支付给试验受试者的时间表已列于知情同意书和将提供给受试者的任何其他书面资料上，应注明按比例支付的方式。

　　3.2 Composition, Functions and Operations

　　3.2组成、职责和操作

　　3.2.1 The IRB/IEC should consist of a reasonable number of members, who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial. It is recommended that the IRB/IEC should include:

　　3.2.1IRB/IEC应由合理数目的成员组成，他们全体都有审评和评价科学、医学和所提议试验的伦理学方面问题的资格和经验。建议IRB/IEC应包括：

　　(a) At least five members.

　　(a)至少5名成员；

　　(b) At least one member whose primary area of interest is in a nonscientific area.

　　(b)至少1名成员关心的主要领域是非科学领域；

　　(c) At least one member who is independent of the institution/trial site.

　　(c)至少1名成员独立于研究机构/试验单位。

　　Only those IRB/IEC members who are independent of the investigator and the sponsor of the trial should vote/provide opinion on a trial-related matter.

　　只有那些独立于试验研究者和申办者的IRB/IEC成员才能对一个试验的相关事项投票/提出意见。

　　A list of IRB/IEC members and their qualifications should be maintained.

　　应当提供一份IRB/IEC成员的名单和他们的资格表。

　　3.2.2 The IRB/IEC should perform its functions according to written operating procedures, should maintain written records of its activities and minutes of its meetings, and should comply with GCP and with the applicable regulatory requirement(s).

　　3.2.2IRB/IEC应当按照书面的操作程序完成其职责，应当保存其活动的书面记录和会议记录，并应当遵守GCP和适用的管理要求。

　　3.2.3 An IRB/IEC should make its decisions at announced meetings at which at least a quorum, as stipulated in its written operating procedures, is present.

　　3.2.3IRB/IEC应当在达到其书面操作程序中规定的法定人数的正式会议上作出决定。

　　3.2.4 Only members who participate in the IRB/IEC review and discussion should vote/provide their opinion and/or advise.

　　3.2.4只有参加IRB/IEC审评和讨论的成员才可投票/提出他们的评价和/或意见。

　　3.2.5 The investigator may provide information on any aspect of the trial, but should not participate in the deliberations of the IRB/IEC or in the vote/opinion of the IRB/IEC.

　　3.2.5研究者应当提供试验各方面的资料，但不应当参加IRB/IEC的审议或IRB/IEC的投票/意见。

　　3.2.6 An IRB/IEC may invite nonmembers with expertise in special areas for assistance.

　　3.2.6 IRB/IEC可邀请在特别领域有专门知识的非成员来帮助。

　　3.3 Procedures

　　3.3程序

　　The IRB/IEC should establish, document in writing, and follow its procedures, which should include:

　　IRB/IEC应当建立书面文件和遵循其程序，程序应包括：

　　3.3.1 Determining its composition (names and qualifications of the members) and the authority under which it is established.

　　3.3.1确定其组成(成员的姓名和资格)和授权；

　　3.3.2 Scheduling, notifying its members of, and conducting its meetings.

　　3.3.2安排时间，通知其成员，举行会议；

　　3.3.3 Conducting initial and continuing review of trials.

　　3.3.3对试验进行初始审评和继续审评；

　　3.3.4 Determining the frequency of continuing review, as appropriate.

　　3.3.4酌情确定继续审评的频度；

　　3.3.5 Providing, according to the applicable regulatory requirements, expedited review and approval/favourable opinion of minor change(s) in ongoing trials that have the approval/favourable opinion of the IRB/IEC.

　　3.3.5依照适用的管理要求，为已经获得IRB/IEC批准/赞成的正在进行的试验的较小修改提供快速审议和批准/赞成意见；

　　3.3.6 Specifying that no subject should be admitted to a trial before the IRB/IEC issues its written approval/favourable opinion of the trial.

　　3.3.6说明在IRB/IEC书面签署对试验的批准/赞成意见之前不得接纳对象进入试验；

　　3.3.7 Specifying that no deviations from, or changes of, the protocol should be initiated without prior written IRB/IEC approval/favourable opinion of an appropriate amendment, except when necessary to eliminate immediate hazards to the subjects or when the change(s) involves only logistical or administrative aspects of the trial (e.g.,change of monitor(s), telephone number(s)) (see 4.5.2).

　　3.3.7说明在方案的适当修改预先得到IRB/IEC的书面批准/赞成之前，不能偏离或改变试验方案，除非有必要排除对于受试者的直接危害，或方案的改变只涉及试验的后勤或管理方面(如更换监查员，改变电话号码)(见4.5.2)；

　　3.3.8 Specifying that the investigator should promptly report to the IRB/IEC:

　　3.3.8说明研究人员应当立即报告IRB/IEC的事项：

　　(a) Deviations from, or changes of, the protocol to eliminate immediate hazards to the trial subjects (see 3.3.7, 4.5.2, 4.5.4).

　　(a)偏离或改变方案以消除对试验受试者的直接危害(见3.3.7，4.5.2，4.5.4)；

　　(b) Changes increasing the risk to subjects and/or affecting significantly the conduct of the trial (see 4.10.2).

　　(b)增加对象风险的改变和/或明显影响试验实施的改变(见4.10.2)；

　　(c) All adverse drug reactions (ADRs) that are both serious and unexpected.

　　(c)所有严重的和非预期的药品不良反应(ADR)

　　(d) New information that may affect adversely the safety of the subjects or the conduct of the trial.

　　(d)对试验的进行或受试者的安全可能有不利影响的新资料。

　　3.3.9 Ensuring that the IRB/IEC promptly notify in writing the investigator/institution concerning:

　　3.3.9确保IRB/IEC迅速书面通知研究者/研究究机构的事项：

　　(a) Its trial-related decisions/opinions.

　　(a)与试验有关的决定/意见；

　　(b) The reasons for its decisions/opinions.

　　(b)IRB/IEC决定/意见的理由；

　　(c) Procedures for appeal of its decisions/opinions.

　　(c)请求IRB/IEC决定/意见的程序。

　　3.4 Records

　　3.4记录

　　The IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members,submitted documents, minutes of meetings, and correspondence) for a period of at least 3-years after completion of the trial and make them available upon request from the regulatory authority(ies).

　　IRB/IEC应当保留全部有关记录(如书写的程序，成员名，成员的职业/联系表，提交的文件，会议记录，以及往来信件)至完成试验后至少3年，并在管理当局需要时可以提供。

　　The IRB/IEC may be asked by investigators, sponsors or regulatory authorities to provide its written procedures and membership lists.

　　研究者、申办者或管理当局可能会要求IRB/IEC提供其书面程序和成员名单。

　　4.INVESTIGATOR

　　4.研究者

　　4.1 Investigator's Qualifications and Agreements

　　4.1研究者的资格和协议

　　4.1.1 The investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirements), and should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the IRB/IEC, and/or the regulatory authority (ies).

　　4.1.1研究者应当在受教育、培训和经验方面有资格承担实施试验的责任，应当符合适用的管理要求所说明的所有条件，并应当通过现时的个人简历和/或申办者、IRB/IEC和/或管理当局要求的其他相关文件提供这种资格证明。

　　4.1.2 The investigator should be thoroughly familiar with the appropriate use of the investigational product(s), as described in the protocol, in the current Investigator's Brochure, in the product information and in other information sources provided by the sponsor.

　　4.1.2研究者应当充分熟悉在试验方案、研究者手册、产品资料以及申办者提供的其他资料中所述的试验用药品的合适用途。

　　4.1.3 The investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements.

　　4.1.3研究者应当了解并遵循GCP和适用的管理要求。

　　4.1.4 The investigator/institution should permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies).

　　4.1.4研究者/研究机构应当允许申办者的监查和稽查，以及管理部门的视察。

　　4.1.5 The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties.

　　4.1.5研究者应当有一份有合适资格、并已委派给他们与试验相关的重要任务的人员名单。

　　4.2 Adequate Resources

　　4.2足够的资源

　　4.2.1 The investigator should be able to demonstrate (e.g., based on retrospective data) a potential for recruiting the required number of suitable subjects within the agreed recruitment period.

　　4.2.1 研究者应能证明(如根据以往的数据)在协议的招募期内接纳所需要数目的合适受试者的可能性。

　　4.2.2 The investigator should have sufficient time to properly conduct and complete the trial within the agreed trial period.

　　4.2.2 研究者在协议的试验期内应当有足够的时间实施和完成试验。

　　4.2.3 The investigator should have available an adequate number of qualified staff and adequate facilities for the foreseen duration of the trial to conduct the trial properly and safely.

　　4.2.3 在可预见的试验期内，研究者应当有足够数量的合格职员和充足的设备来正确、安全地实施试验。

　　4.2.4 The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions.

　　4.2.4 研究者应当保证所有的试验辅助人员已充分了解试验方案，试验用药品，及他们与试验相关的责任和职能。

　　ADDENDUM

　　附录

　　4.2.5 The investigator is responsible for supervising any individual or party to whom the investigator delegates trial-related duties and functions conducted at the trial site.

　　4.2.5研究者负责监督被其授权在本试验中心实施试验相关职责和功能的个体和团体。

　　4.2.6 If the investigator/institution retains the services of any individual or party to perform trial-related duties and functions, the investigator/institution should ensure this individual or party is qualified to perform those trial-related duties and functions and should implement procedures to ensure the integrity of the trial-related duties and functions performed and any data generated.

　　4.2.6如果研究者/机构授权任何个人或团体执行试验相关的责任和职能，研究者应当保证这些被授权的个人或团体有资格执行这些试验相关的职责和功能。研究者应该建立并执行相应的程序以保证试验相关职责、功能的执行与任何数据生成的完整性。

　　4.3 Medical Care of Trial Subjects

　　4.3受试者的医疗保健

　　4.3.1 A qualified physician (or dentist, when appropriate), who is an investigator or a subinvestigator for the trial, should be responsible for all trial-related medical (or dental) decisions.

　　4.3.1作为一名研究者或次级研究人员的合格医生(或牙医)应当对与试验有关的所有医学(牙科)决定负责。

　　4.3.2 During and following a subject's participation in a trial, the investigator/institution should ensure that adequate medical care is provided to a subject for any adverse events, including clinically significant laboratory values, related to the trial. The investigator/institution should inform a subject when medical care is needed for intercurrent illness(es) of which the investigator becomes aware.

　　4.3.2在受试者参加一个试验期间或以后，研究者/研究机构应当保证为受试者的任何不良反应，包括与试验有关的临床上有意义的实验室测定值提供合宜的医疗保健。研究者在意识到合并疾病需要医疗保健时，应当通知受试者。

　　4.3.3 It is recommended that the investigator inform the subject's primary physician about the subject's participation in the trial if the subject has a primary physician and if the subject agrees to the primary physician being informed.

　　4.3.3 如果受试者有自己的主管医生并且受试者同意让自己的主管医生知道，建议研究者将受试者参加试验的事通知其主管医生。

　　4.3.4 Although a subject is not obliged to give his/her reason(s) for withdrawing prematurely from a trial, the investigator should make a reasonable effort to ascertain the reason(s), while fully respecting the subject’s rights.

　　4.3.4尽管一名受试者没有义务给出他/她中途退出试验的理由，研究者仍应当在充分尊重其权利的同时作出合理的努力确认其退出理由。

　　4.4 Communication with IRB/IEC

　　4.4与IRB/IEC的交流

　　4.4.1 Before initiating a trial, the investigator/institution should have written and dated approval/favourable opinion from the IRB/IEC for the trial protocol, written informed consent form, consent form updates, subject recruitment procedures (e.g., advertisements), and any other written information to be provided to subjects.

　　4.4.1 在开始一个试验前，研究者/研究机构应当有IRB/IEC对试验方案、知情同意书、知情同意书的更新、对象招募程序(如广告)、以及提供给受试者的任何其他书面资料的书面的、注明日期的批准/赞成意见。

　　4.4.2 As part of the investigator's/institution's written application to the IRB/IEC, the investigator/institution should provide the IRB/IEC with a current copy of the Investigator's Brochure. If the Investigator's Brochure is updated during the trial, the investigator/institution should supply a copy of the updated Investigator's Brochure to the IRB/IEC.

　　4.4.2 作为研究者/研究机构向IRB/IEC书面申请的一部分，研究者/研究机构应当向IRB/IEC提供研究者手册的最新版本。如果研究者手册在试验中进行了更新，研究者/研究机构应当向IRB/IEC提供更新的研究者手册。

　　4.4.3 During the trial the investigator/institution should provide to the IRB/IEC all documents subject to review.

　　4.4.3 在试验期间，研究者/研究机构应当向IRB/IEC提供全部需要进行审评的文件。

　　4.5 Compliance with Protocol

　　4.5对试验方案的依从性

　　4.5.1 The investigator/institution should conduct the trial in compliance with the protocol agreed to by the sponsor and, if required, by the regulatory authority(ies) and which was given approval/favourable opinion by the IRB/IEC. The investigator/institution and the sponsor should sign the protocol, or an alternative contract, to confirm agreement.

　　4.5.1 研究者/研究机构应当按照经申办者和(如有必要)管理当局同意、并得到IRB/IEC批准/赞成的方案实施试验。研究者/研究机构和申办者应当在方案上或试验合同上签字，确认同意方案。

　　4.5.2 The investigator should not implement any deviation from, or changes of the protocol without agreement by the sponsor and prior review and documented approval/favourable opinion from the IRB/IEC of an amendment, except where necessary to eliminate an immediate hazard(s) to trial subjects, or when the change(s) involves only logistical or administrative aspects of the trial (e.g., change in monitor(s), change of telephone number(s)).

　　4.5.2 研究者在没有取得申办者同意和事先得到IRB/IEC对于一个方案修改的审评与书面批准/赞成时，不应当偏离或改变方案，除非必须消除试验对象的直接危险或这些改变只涉及试验的供应或管理方面(如更换监查员，改变电话号码)。

　　4.5.3 The investigator, or person designated by the investigator, should document and explain any deviation from the approved protocol.

　　4.5.3研究者，或由研究者指定的人，应当记录和解释与已批准方案的任何偏离。

　　4.5.4 The investigator may implement a deviation from, or a change of, the protocol to eliminate an immediate hazard(s) to trial subjects without prior IRB/IEC approval/favourable opinion. As soon as possible, the implemented deviation or change, the reasons for it, and, if appropriate, the proposed protocol amendment(s) should be submitted:

　　4.5.4 为了消除对试验对象的直接危险，研究者可以没有IRB/IEC的预先批准/赞成意见偏离或改变方案。所实施的偏离或改变、改变的理由、以及所提议的方案修改应尽可能快地提交给：

　　(a) to the IRB/IEC for review and appro val/favourable opinion,

　　(a)IRB/IEC审评并得到批准/赞成；

　　(b) to the sponsor for agreement and, if required,

　　(b)申办者征得同意和，如果需要；

　　(c) to the regulatory authority(ies).

　　(c)管理当局。

　　4.6 Investigational Product(s)

　　4.6试验用药品

　　4.6.1 Responsibility for investigational product(s) accountability at the trial site(s) rests with the investigator/institution.

　　4.6.1在试验单位，试验用药品计数的责任归于研究者/研究机构。

　　4.6.2 Where allowed/required, the investigator/institution may/should assign some or all of the investigator’s/institution’s duties for investigational product(s) accountability at the trial site(s) to an appropriate pharmacist or another appropriate individual who is under the supervision of the investigator/institution..

　　4.6.2只要允许/需要，研究者/研究机构可以/应当将试验单位研究者的/机构对试验用药品计数的责任部分或全部指派给在研究者/研究机构监督下的合适的药师或其他适当的人员。

　　4.6.3 The investigator/institution and/or a pharmacist or other appropriate individual, who is designated by the investigator/institution, should maintain records of the product’s delivery to the trial site, the inventory at the site, the use by each subject, and the return to the sponsor or alternative disposition of unused product(s). These records should include dates, quantities, batch/serial numbers, expiration dates (if applicable), and the unique code numbers assigned to the investigational product(s) and trial subjects. Investigators should maintain records that document adequately that the subjects were provided the doses specified by the protocol and reconcile all investigational product(s) received from the sponsor.

　　4.6.3研究者/研究机构和/或受研究者/研究机构指派的一名药师或其他合适的个人，应当保存试验用药品交到试验单位的记录，在试验单位的存货清单，每位受试者的使用记录，和未使用药品交还给申办者或另法处置的记录。这些记录应包括日期、数量、批号/系列号、失效期(如有)、和分配给试验用药品和试验受试者的特别编码。研究者应保持记载有按方案说明给予受试者药量的记录，并应与从申办者处收到的试验用药品总数一致。

　　4.6.4 The investigational product(s) should be stored as specified by the sponsor (see 5.13.2 and 5.14.3) and in accordance with applicable regulatory requirement(s).

　　4.6.4试验用药品应当按申办者的说明储存(见5.13.2和5.14.3)并符合适用的管理要求。

　　4.6.5 The investigator should ensure that the investigational product(s) are used only in accordance with the approved protocol.

　　4.6.5研究者应当保证试验用药品只按已批准的方案使用。

　　4.6.6 The investigator