ICH-GCP中英文對照(完整)

1、 ICH 三方協(xié)調(diào)指導(dǎo)原則 E6 ICH GCP指導(dǎo)原則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 tha

2、t 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. 臨床試驗管理規(guī)范（GCP）是設(shè)計、實施、記錄和報告設(shè)計人類對象參加的試驗國際性倫理和科學(xué)質(zhì)量標(biāo)準(zhǔn)。遵循這一標(biāo)準(zhǔn)為保護(hù)對象的權(quán)利、安全性和健康，為與源于赫爾辛基宣言的原則保持一致以及臨床試驗數(shù)據(jù)的可

3、信性提供了公眾保證。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指導(dǎo)原則的目的是為歐盟、日本和美國提供統(tǒng)一的標(biāo)準(zhǔn)，以促進(jìn)這些管理當(dāng)局在其權(quán)限內(nèi)相互接受臨床數(shù)

4、據(jù)。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). 本指導(dǎo)原則的發(fā)展考慮了歐盟、日本、美國，以及澳大利亞、加拿大、北歐國家和世界衛(wèi)生組織（WHO）的現(xiàn)行GCP。This

5、 guideline should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities. 在產(chǎn)生打算提交給管理當(dāng)局的臨床數(shù)據(jù)時應(yīng)當(dāng)遵循本指導(dǎo)原則。The principles established in this guideline may also be applied to other clinical investigations that may have an impact on the safety and well-

6、being of human subjects. 本指導(dǎo)原則中確立的原則也可應(yīng)用于可能影響人類對象安全和健康的其他臨床研究。1. GLOSSARY術(shù)語1.1 Adverse Drug Reaction (ADR) 藥品不良反應(yīng)（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 res

7、ponses 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

8、. 在一個新的藥品或藥品的新用途在批準(zhǔn)之前的臨床實踐，尤其是治療劑量尚未確定前，ADR是指與藥物任何劑量有關(guān)的所有有害的和非意求的反應(yīng)都應(yīng)被考慮為藥物不良反應(yīng)。該術(shù)語用于藥品是指在藥品與不良反應(yīng)之間的因果關(guān)系至少有一個合理的可能性，即不能排除這種關(guān)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 ther

9、apy of diseases or for modification of physiological function (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting). 對已上市藥品，ADR指人對用于預(yù)防、診斷或治療疾病或改善生理功能的藥物在常用劑量出現(xiàn)的有害和非意求反應(yīng)（參見ICH臨床安全性數(shù)據(jù)管理指導(dǎo)原則：快速報告的定義和標(biāo)準(zhǔn)）。1.2 Adverse Event (AE) 不良事件（AE）Any untoward

10、 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 findin

11、g), 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). 在用藥病人或臨床研究對象中發(fā)生的任何不幸醫(yī)

12、療事件，他不一定要與治療有因果關(guān)系。因此，一個不良事件（AE）可以是與使用（研究）藥物在時間上相關(guān)的任何不利的和非意求的征兆（包括異常的實驗室發(fā)現(xiàn)）、癥狀或疾病，而不管其是否與藥物有關(guān)（參見ICH臨床安全性數(shù)據(jù)管理指導(dǎo)原則：快速報告的定義和標(biāo)準(zhǔn)）。1.3 Amendment (to the protocol) 修改（試驗方案）See Protocol Amendment. 見試驗方案修改1.4 Applicable Regulatory Requirement(s) 適用的管理要求Any law(s) and regulation(s) addressing the conduct of cl

13、inical trials of investigational products. 有關(guān)實施試驗用藥品臨床試驗的任何法律和法規(guī)。1.5 Approval (in relation to Institutional Review Boards) 批準(zhǔn)（機(jī)構(gòu)審評委員會）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

14、, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements. IRB表示贊成的決定：指對一項臨床試驗已經(jīng)進(jìn)行審評，并可在IRB、研究機(jī)構(gòu)、GCP和適用管理要求的約束下由研究機(jī)構(gòu)方實施。1.6 Audit稽查A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related act

15、ivities 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). 對試驗相關(guān)活動和文件進(jìn)行系統(tǒng)和獨(dú)立的監(jiān)察，以判定試驗的實施和數(shù)據(jù)的記錄、分析與報告是否符合試驗方案、申辦者的標(biāo)準(zhǔn)操作程序（SOP）

16、、臨床試驗管理規(guī)范（GCP）以及適用的管理要求。1.7 Audit Certificate稽查證書A declaration of confirmation by the auditor that an audit has taken place. 稽查員確認(rèn)已進(jìn)行稽查的聲明。1.8 Audit Report稽查報告A written evaluation by the sponsors auditor of the results of the audit. 申辦者方稽查關(guān)于稽查結(jié)果的書面評價1.9 Audit Trail稽查軌跡Documentation that allows recon

17、struction of the course of events. 允許重復(fù)出現(xiàn)事件過程的文件。1.10 Blinding/Masking設(shè)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), investi

18、gator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s).一種使試驗的一個或幾個部分的人員不知道治療分配的程序。單盲通常指對象不知道；雙盲通常指對象、研究人員、監(jiān)察員以及在某些情況下數(shù)據(jù)分析人員也不知道治療分配。1.11 Case Report Form (CRF) 病例報告表（CRF）A printed, optical, or electronic document designed to record all of the protocol req

19、uired information to be reported to the sponsor on each trial subject. 設(shè)計用來記錄試驗方案要求向申辦者報告的有關(guān)每一例對象的全部信息的印刷的、光學(xué)的或電子的文件。1.12 Clinical Trial/Study 臨床試驗/研究Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigat

20、ional 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 ar

21、e synonymous.在人類對象進(jìn)行的任何意在發(fā)現(xiàn)或證實一種試驗用藥品的臨床、藥理學(xué)和/或其他藥效學(xué)作用；和/或確定一種試驗用藥品的任何不良反應(yīng)；和/或研究一種試驗用藥品的吸收、分布、代謝和排泄，以確定藥物的安全性和/或有效性的研究。術(shù)語臨床試驗和臨床研究同義。1.13 Clinical Trial/Study Report 臨床試驗/研究報告A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in

22、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). 在人類對象進(jìn)行的任何治療、預(yù)防或診斷劑的試驗/研究的書面描述。臨床和統(tǒng)計描述、陳述和分析全部列入該單份報告（見ICH臨床研究報告的結(jié)構(gòu)和內(nèi)容指導(dǎo)原則）。1.14 Comparator (Product) 對照（

23、藥物）An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial. 臨床試驗中用做對照的試驗用藥品或市售藥物（即陽性對照）或安慰劑。1.15 Compliance (in relation to trials) 依從性（關(guān)于試驗的）Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the

24、 applicable regulatory requirements. 遵循與試驗有關(guān)的所有要求、臨床試驗管理規(guī)范（GCP）要求和適用的管理要求。1.16 Confidentiality 保密性Prevention of disclosure, to other than authorized individuals, of a sponsors proprietary information or of a subjects identity. 不得向未經(jīng)授權(quán)的個人泄漏申辦者所有的資料或?qū)ο蟮纳矸荨?.17 Contract合同A written, dated, and signed ag

25、reement 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. 在兩個或幾個有關(guān)方之間的一份書面的、有日期和簽字的協(xié)議，其中陳述了關(guān)于工作和責(zé)任和分派的安排，以及關(guān)于財務(wù)問題的安排。試驗方案可以作為合同的基礎(chǔ)。1

26、.18 Coordinating Committee協(xié)調(diào)委員會A committee that a sponsor may organize to coordinate the conduct of a multicentre trial. 申辦者組織的協(xié)調(diào)實施多中心試驗的委員會。1.19 Coordinating Investigator協(xié)調(diào)研究者An investigator assigned the responsibility for the coordination of investigators at different centres participating in a mu

27、lticentre trial. 被指定負(fù)責(zé)協(xié)調(diào)參加一項多中心試驗的各中心研究者工作的一名研究者。1.20 Contract Research Organization (CRO) 合同研究組織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. 與申辦者訂立契約完成一個或多個有關(guān)申辦者方的試驗任務(wù)和功能的個人或組織（商業(yè)性的，學(xué)術(shù)

28、的或其他）。1.21 Direct Access 直接訪問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 take all reasonable

29、 precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects identities and sponsors proprietary information. 允許監(jiān)察、分析、核對和復(fù)制任何對于評價臨床試驗有重要意義的記錄和報告。直接訪問的任何一方（如國內(nèi)和國外的管理當(dāng)局，申辦者方的監(jiān)察員和稽查員）應(yīng)當(dāng)受適用管理要求的缺書，采取一切合理的預(yù)防措施維護(hù)對象身份和申辦者資料的保密性。1.22 Documentati

30、on 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. 描述或記錄試驗的方法、實施和/或

31、結(jié)果，影響試驗的因素，以及采取的措施等的任何形式的記錄（包括但不限于書面、電子、磁性和光學(xué)的記錄，以及掃描、X射線和心電圖）。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). 指各自和合在一起允許評價一個研

32、究的執(zhí)行情況和所得數(shù)據(jù)的質(zhì)量文件（見8.實施臨床試驗的必需文件）。1.24 Good Clinical Practice (GCP) 臨床試驗管理規(guī)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

33、the rights, integrity, and confidentiality of trial subjects are protected. 是臨床試驗設(shè)計、實施、執(zhí)行、監(jiān)察、稽查、記錄、分析和報告的標(biāo)準(zhǔn)，它為數(shù)據(jù)和所報告結(jié)果的可信性和準(zhǔn)確性提供了保證，并保護(hù)試驗對象的權(quán)利、完整性和機(jī)密性。1.25 Independent Data-Monitoring Committee (IDMC) (Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee) 獨(dú)立的數(shù)據(jù)監(jiān)察委員會（IDMC

34、）（數(shù)據(jù)和安全監(jiān)察委員會，監(jiān)察委員會，數(shù)據(jù)監(jiān)察委員會）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. 由申辦者

35、設(shè)立一個獨(dú)立的數(shù)據(jù)監(jiān)察委員會，它定期對研究進(jìn)展、安全性數(shù)據(jù)和有效性終點(diǎn)進(jìn)行評估，向申辦者建議是否繼續(xù)、調(diào)整或停止試驗。1.26 Impartial Witness 公平的見證人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 acceptable represent

36、ative cannot read, and who reads the informed consent form and any other written information supplied to the subject. 獨(dú)立與臨床試驗、不受與試驗有關(guān)人員的不公正影響的個人。如果對象或?qū)ο蟮暮戏ń邮艽砣瞬荒荛喿x，他/她將參與知情同意過程，并向?qū)ο箝喿x提供給她們的知情同意書和其他書面資料。1.27 Independent Ethics Committee (IEC) 獨(dú)立的倫理委員會（IEC）An independent body (a review board or a com

37、mittee, 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 protectio

38、n, 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. 一個由醫(yī)學(xué)專業(yè)人員和非醫(yī)學(xué)專業(yè)人員組成的獨(dú)立機(jī)構(gòu)（研究機(jī)構(gòu)的、地區(qū)

39、的、國家的或超國家的審評機(jī)構(gòu)或委員會），其職責(zé)是保證參加試驗對象的權(quán)益、安全性和健康；并通過對試驗方案、研究人員、設(shè)施以及用于獲得和記錄試驗對象知情同意的方法和材料的合理性進(jìn)行審評和批準(zhǔn)/提供起促進(jìn)作用的意見以對這種保護(hù)提供公眾保證The legal status, composition, function, operations and regulatory requirements pertaining to Independent Ethics Committees may differ among countries, but should allow the Independent

40、 Ethics Committee to act in agreement with GCP as described in this guideline. 在不同的國家，獨(dú)立的倫理委員會的法律地位、組成、職責(zé)、操作和適用的管理要求可能不用，但是應(yīng)當(dāng)如本指導(dǎo)原則所述，允許獨(dú)立的倫理委員會按GCP進(jìn)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 havi

41、ng 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. 一個對象在被告知與其作出決定有關(guān)的所有試驗信息后，資源確認(rèn)他或她參加一個特定試驗的意愿過程。知情同意采用書面的、簽字并注明日期的知情同意書。1.29 Inspection 視察The act by a r

42、egulatory 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 organizations (CRO

43、s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies). 管理當(dāng)局在試驗單位、申辦者和/或合同研究組織或管理當(dāng)局認(rèn)為何時的其他機(jī)構(gòu)對其認(rèn)為與臨床試驗有關(guān)的文件、設(shè)備、記錄和其他資源進(jìn)行的官方審查的活動。1.30 Institution (medical) （醫(yī)學(xué)）研究機(jī)構(gòu)Any public or private entity or agency or medical or dental facility where clinical trials are con

44、ducted. 實施臨床試驗任何或私人的實體、代理機(jī)構(gòu)、醫(yī)學(xué)或齒科設(shè)施。1.31 Institutional Review Board (IRB) 機(jī)構(gòu)審評委員會（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, am

45、ong 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. 由醫(yī)學(xué)、科學(xué)和非科學(xué)成員組成的一個獨(dú)立機(jī)構(gòu)，其職責(zé)是通過對試驗方案及其修訂本，獲得受試對象知情同意所用的方法和資料進(jìn)行審評、批準(zhǔn)和繼續(xù)審評，確保一項試驗的受試對象的權(quán)

46、利、安全和健康得到保護(hù)。1.32 Interim Clinical Trial/Study Report 臨床試驗/研究中期報告A report of intermediate results and their evaluation based on analyses performed during the course of a trial. 根據(jù)試驗進(jìn)行過程中所做的分析寫出的中期結(jié)果和評價的報告1.33 Investigational Product 試驗用藥品A pharmaceutical form of an active ingredient or placebo being

47、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.

48、一種在臨床試驗中供試驗的或作為對照的活性成分或安慰劑的藥物制劑。包括一個已上市藥品以不同于所批準(zhǔn)的方式適用或組合（制劑或包裝），或用于一個未經(jīng)批準(zhǔn)的適應(yīng)證，或用于收集一個已批準(zhǔn)用法的更多資料。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 leade

49、r of the team and may be called the principal investigator. See also Subinvestigator. 負(fù)責(zé)在一個試驗單位實施臨床試驗的人。如果在一個試驗單位是由一組人員實施試驗，研究者指這個組的負(fù)責(zé)人，也稱為主要研究者。見次級研究人員。1.35 Investigator / Institution 研究者/研究機(jī)構(gòu)An expression meaning the investigator and/or institution, where required by the applicable regulatory requ

50、irements. 表示“符合適用管理要求的研究者和/或研究機(jī)構(gòu)”1.36 Investigators Brochure 研究者手冊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. Investigators Brochure). 與試驗藥品在人類對象中的研究有關(guān)的臨床和非臨床資料的匯編（見7.研

51、究者手冊）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 subjects participation in the clinical trial. 在適用法律下被授權(quán)代表一位未來的對象同意參加臨床試驗的個人，或司法人員或其他機(jī)關(guān)。1.38 Monitoring 監(jiān)察The act of ove

52、rseeing 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). 監(jiān)督一個臨床試驗的進(jìn)展，保證臨床試驗按照試驗方案、標(biāo)準(zhǔn)操作程序（SOP）、臨床試驗管理規(guī)范（GCP）

53、和適用的管理要求實施、記錄和報告的活動。1.39 Monitoring Report 監(jiān)察報告A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsors SOPs. 監(jiān)察員在每一次現(xiàn)場訪問和/或其他與試驗有關(guān)的交流后，根據(jù)申辦者的SOP寫給申辦者的書面報告。1.40 Multicentre Trial 多中心試驗A clinical trial conducted accordin

54、g to a single protocol but at more than one site, and therefore, carried out by more than one investigator. 按照一個試驗方案，在一個以上試驗單位實施，因此由一名以上研究者完成的臨床試驗。1.41 Nonclinical Study 非臨床試驗Biomedical studies not performed on human subjects. 不是在人類對象進(jìn)行的生物醫(yī)學(xué)研究。1.42 Opinion (in relation to Independent Ethics Committe

55、e) 意見（與獨(dú)立的倫理委員會相關(guān)）The judgement and/or the advice provided by an Independent Ethics Committee (IEC). 由獨(dú)立的倫理委員會（IEC）給出的評價和/或建議1.43 Original Medical Record 原始醫(yī)學(xué)記錄See Source Documents. 見源文件1.44 Protocol 試驗方案A document that describes the objective(s), design, methodology, statistical considerations, and

56、 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. 一個闡明試驗的目的、設(shè)計、方法學(xué)、統(tǒng)計學(xué)考慮和組織的文件。試驗方案通常

57、也給出試驗的背景和理論基礎(chǔ)，但者這可以寫在與方案有關(guān)的其他參考文件中。在ICH指導(dǎo)原則中，試驗方案這一術(shù)語指試驗方案和方案的修改。1.45 Protocol Amendment 試驗方案的修改A written description of a change(s) to or formal clarification of a protocol. 對試驗方案的改變或澄清的書面描述。1.46 Quality Assurance (QA) 質(zhì)量保證（QA）All those planned and systematic actions that are established to ensure

58、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). 為保證試驗的進(jìn)行和數(shù)據(jù)產(chǎn)生、記錄以及報告都符合臨床試驗管理規(guī)范（GCP）和適用管理要求所建立的有計劃的系統(tǒng)活動。1.47 Quality Control (QC) 質(zhì)量控制（QC）The operational techniqu

59、es and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled. 在質(zhì)量保證系統(tǒng)內(nèi)所采取的操作技術(shù)和活動，以查證與試驗相關(guān)的活動都符合質(zhì)量要求。1.48 Randomization 隨機(jī)化The process of assigning trial subjects to treatment or control groups using

60、an element of chance to determine the assignments in order to reduce bias. 為了減少偏倚，采用機(jī)遇決定分配的原理將試驗對象分配倒治療組或?qū)φ战M的過程。1.49 Regulatory Authorities 管理當(dāng)局Bodies having the power to regulate. In the ICH GCP guideline the expression Regulatory Authorities includes the authorities that review submitted clinical