ICHGCP中英文對(duì)照

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 that

2、 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(yàn)管理規(guī)范（gcp）是設(shè)計(jì)、實(shí)施、記錄和報(bào)告設(shè)計(jì)人類(lèi)對(duì)象參加的試驗(yàn)國(guó)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(duì)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(yàn)數(shù)據(jù)的可信

3、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(guó)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)據(jù)

4、。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(guó)，以及澳大利亞、加拿大、北歐國(guó)家和世界衛(wèi)生組織（who）的現(xiàn)行g(shù)cp。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(shí)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-b

6、eing 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(lèi)對(duì)象安全和健康的其他臨床研究。1. glossary1. 術(shù)語(yǔ)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 r

7、esponses 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 o

8、ut. 在一個(gè)新的藥品或藥品的新用途在批準(zhǔn)之前的臨床實(shí)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(yǔ)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(gè)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 th

9、erapy of diseases or for modification of physiological function (see the ich guideline for clinical safety data management: definitions and standards for expedited reporting). 對(duì)已上市藥品，adr指人對(duì)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(jiàn)ich臨床安全性數(shù)據(jù)管理指導(dǎo)原則：快速報(bào)告的定義和標(biāo)準(zhǔn)）。1.2 adverse event (ae) 不良事件（ae）any untowa

10、rd 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 find

11、ing), 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(duì)象中發(fā)生的任何不

12、幸醫(yī)療事件，他不一定要與治療有因果關(guān)系。因此，一個(gè)不良事件（ae）可以是與使用（研究）藥物在時(shí)間上相關(guān)的任何不利的和非意求的征兆（包括異常的實(shí)驗(yàn)室發(fā)現(xiàn)）、癥狀或疾病，而不管其是否與藥物有關(guān)（參見(jiàn)ich臨床安全性數(shù)據(jù)管理指導(dǎo)原則：快速報(bào)告的定義和標(biāo)準(zhǔn)）。1.3 amendment (to the protocol) 修改（試驗(yàn)方案）see protocol amendment. 見(jiàn)試驗(yàn)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

13、clinical trials of investigational products. 有關(guān)實(shí)施試驗(yàn)用藥品臨床試驗(yàn)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(píng)委員會(huì)）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 i

14、rb, the institution, good clinical practice (gcp), and the applicable regulatory requirements. irb表示贊成的決定：指對(duì)一項(xiàng)臨床試驗(yàn)已經(jīng)進(jìn)行審評(píng)，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(shí)施。1.6 audit稽查a systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related a

15、ctivities 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(duì)試驗(yàn)相關(guān)活動(dòng)和文件進(jìn)行系統(tǒng)和獨(dú)立的監(jiān)察，以判定試驗(yàn)的實(shí)施和數(shù)據(jù)的記錄、分析與報(bào)告是否符合試驗(yàn)方案、申辦者的標(biāo)準(zhǔn)操作程序（so

16、p）、臨床試驗(yàn)管理規(guī)范（gcp）以及適用的管理要求。1.7 audit certificate稽查證書(shū)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(bào)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(shū)面評(píng)價(jià)1.9 audit trail稽查軌跡documentation that allows rec

17、onstruction of the course of events. 允許重復(fù)出現(xiàn)事件過(guò)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), inves

18、tigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s).一種使試驗(yàn)的一個(gè)或幾個(gè)部分的人員不知道治療分配的程序。單盲通常指對(duì)象不知道；雙盲通常指對(duì)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(bào)告表（crf）a printed, optical, or electronic document designed to record all of the protocol r

19、equired information to be reported to the sponsor on each trial subject. 設(shè)計(jì)用來(lái)記錄試驗(yàn)方案要求向申辦者報(bào)告的有關(guān)每一例對(duì)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(yàn)/研究any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investig

20、ational 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

21、are synonymous.在人類(lèi)對(duì)象進(jìn)行的任何意在發(fā)現(xiàn)或證實(shí)一種試驗(yàn)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(yàn)用藥品的任何不良反應(yīng)；和/或研究一種試驗(yàn)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(yǔ)臨床試驗(yàn)和臨床研究同義。1.13 clinical trial/study report 臨床試驗(yàn)/研究報(bào)告a written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, i

22、n 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(lèi)對(duì)象進(jìn)行的任何治療、預(yù)防或診斷劑的試驗(yàn)/研究的書(shū)面描述。臨床和統(tǒng)計(jì)描述、陳述和分析全部列入該單份報(bào)告（見(jiàn)ich臨床研究報(bào)告的結(jié)構(gòu)和內(nèi)容指導(dǎo)原則）。1.14 comparator (product) 對(duì)

23、照（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(yàn)中用做對(duì)照的試驗(yàn)用藥品或市售藥物（即陽(yáng)性對(duì)照）或安慰劑。1.15 compliance (in relation to trials) 依從性（關(guān)于試驗(yàn)的）adherence to all the trial-related requirements, good clinical practice (gcp) requirements, and t

24、he applicable regulatory requirements. 遵循與試驗(yàn)有關(guān)的所有要求、臨床試驗(yàn)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(gè)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

25、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. 在兩個(gè)或幾個(gè)有關(guān)方之間的一份書(shū)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(cái)務(wù)問(wèn)題的安排。試驗(yàn)方案可以作為合同的基礎(chǔ)

26、。1.18 coordinating committee協(xié)調(diào)委員會(huì)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(shí)施多中心試驗(yàn)的委員會(huì)。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

27、multicentre trial. 被指定負(fù)責(zé)協(xié)調(diào)參加一項(xiàng)多中心試驗(yàn)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(gè)或多個(gè)有關(guān)申辦者方的試驗(yàn)任務(wù)和功能的個(gè)人或組織（商業(yè)性的，

28、學(xué)術(shù)的或其他）。1.21 direct access 直接訪問(wèn)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 reasonab

29、le 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(duì)和復(fù)制任何對(duì)于評(píng)價(jià)臨床試驗(yàn)有重要意義的記錄和報(bào)告。直接訪問(wèn)的任何一方（如國(guó)內(nèi)和國(guó)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(shū)，采取一切合理的預(yù)防措施維護(hù)對(duì)象身份和申辦者資料的保密性。1.22 documenta

30、tion 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(yàn)的方法、實(shí)施和

31、/或結(jié)果，影響試驗(yàn)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(shū)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(píng)價(jià)一

32、個(gè)研究的執(zhí)行情況和所得數(shù)據(jù)的質(zhì)量文件（見(jiàn)8.實(shí)施臨床試驗(yàn)的必需文件）。1.24 good clinical practice (gcp) 臨床試驗(yàn)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 tha

33、t the rights, integrity, and confidentiality of trial subjects are protected. 是臨床試驗(yàn)設(shè)計(jì)、實(shí)施、執(zhí)行、監(jiān)察、稽查、記錄、分析和報(bào)告的標(biāo)準(zhǔn)，它為數(shù)據(jù)和所報(bào)告結(jié)果的可信性和準(zhǔn)確性提供了保證，并保護(hù)試驗(yàn)對(duì)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(huì)（id

34、mc）（數(shù)據(jù)和安全監(jiān)察委員會(huì)，監(jiān)察委員會(huì)，數(shù)據(jù)監(jiān)察委員會(huì)）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

35、辦者設(shè)立一個(gè)獨(dú)立的數(shù)據(jù)監(jiān)察委員會(huì)，它定期對(duì)研究進(jìn)展、安全性數(shù)據(jù)和有效性終點(diǎn)進(jìn)行評(píng)估，向申辦者建議是否繼續(xù)、調(diào)整或停止試驗(yàn)。1.26 impartial witness 公平的見(jiàn)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 represe

36、ntative 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(yàn)、不受與試驗(yàn)有關(guān)人員的不公正影響的個(gè)人。如果對(duì)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(guò)程，并向?qū)ο箝喿x提供給她們的知情同意書(shū)和其他書(shū)面資料。1.27 independent ethics committee (iec) 獨(dú)立的倫理委員會(huì)（iec）an independent body (a review board or a c

37、ommittee, 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 protect

38、ion, 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(gè)由醫(yī)學(xué)專(zhuān)業(yè)人員和非醫(yī)學(xué)專(zhuān)業(yè)人員組成的獨(dú)立機(jī)構(gòu)（研究機(jī)構(gòu)的、

39、地區(qū)的、國(guó)家的或超國(guó)家的審評(píng)機(jī)構(gòu)或委員會(huì)），其職責(zé)是保證參加試驗(yàn)對(duì)象的權(quán)益、安全性和健康；并通過(guò)對(duì)試驗(yàn)方案、研究人員、設(shè)施以及用于獲得和記錄試驗(yàn)對(duì)象知情同意的方法和材料的合理性進(jìn)行審評(píng)和批準(zhǔn)/提供起促進(jìn)作用的意見(jiàn)以對(duì)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 independe

40、nt ethics committee to act in agreement with gcp as described in this guideline. 在不同的國(guó)家，獨(dú)立的倫理委員會(huì)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(huì)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 ha

41、ving 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(gè)對(duì)象在被告知與其作出決定有關(guān)的所有試驗(yàn)信息后，資源確認(rèn)他或她參加一個(gè)特定試驗(yàn)的意愿過(guò)程。知情同意采用書(shū)面的、簽字并注明日期的知情同意書(shū)。1.29 inspection 視察the act by a

42、 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 organizations (c

43、ros) facilities, or at other establishments deemed appropriate by the regulatory authority(ies). 管理當(dāng)局在試驗(yàn)單位、申辦者和/或合同研究組織或管理當(dāng)局認(rèn)為何時(shí)的其他機(jī)構(gòu)對(duì)其認(rèn)為與臨床試驗(yàn)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(dòng)。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 c

44、onducted. 實(shí)施臨床試驗(yàn)任何或私人的實(shí)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(píng)委員會(huì)（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,

45、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. 由醫(yī)學(xué)、科學(xué)和非科學(xué)成員組成的一個(gè)獨(dú)立機(jī)構(gòu)，其職責(zé)是通過(guò)對(duì)試驗(yàn)方案及其修訂本，獲得受試對(duì)象知情同意所用的方法和資料進(jìn)行審評(píng)、批準(zhǔn)和繼續(xù)審評(píng)，確保一項(xiàng)試驗(yàn)的受試對(duì)象

46、的權(quán)利、安全和健康得到保護(hù)。1.32 interim clinical trial/study report 臨床試驗(yàn)/研究中期報(bào)告a report of intermediate results and their evaluation based on analyses performed during the course of a trial. 根據(jù)試驗(yàn)進(jìn)行過(guò)程中所做的分析寫(xiě)出的中期結(jié)果和評(píng)價(jià)的報(bào)告1.33 investigational product 試驗(yàn)用藥品a pharmaceutical form of an active ingredient or placebo bein

47、g 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(yàn)中供試驗(yàn)的或作為對(duì)照的活性成分或安慰劑的藥物制劑。包括一個(gè)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(gè)未經(jīng)批準(zhǔn)的適應(yīng)證，或用于收集一個(gè)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 lea

49、der of the team and may be called the principal investigator. see also subinvestigator. 負(fù)責(zé)在一個(gè)試驗(yàn)單位實(shí)施臨床試驗(yàn)的人。如果在一個(gè)試驗(yàn)單位是由一組人員實(shí)施試驗(yàn)，研究者指這個(gè)組的負(fù)責(zé)人，也稱(chēng)為主要研究者。見(jiàn)次級(jí)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 re

50、quirements. 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(cè)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(yàn)藥品在人類(lèi)對(duì)象中的研究有關(guān)的臨床和非臨床資料的匯編（見(jiàn)7

51、.研究者手冊(cè)）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(lái)的對(duì)象同意參加臨床試驗(yàn)的個(gè)人，或司法人員或其他機(jī)關(guān)。1.38 monitoring 監(jiān)察the act of o

52、verseeing 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(gè)臨床試驗(yàn)的進(jìn)展，保證臨床試驗(yàn)按照試驗(yàn)方案、標(biāo)準(zhǔn)操作程序（sop）、臨床試驗(yàn)管理規(guī)范（gc

53、p）和適用的管理要求實(shí)施、記錄和報(bào)告的活動(dòng)。1.39 monitoring report 監(jiān)察報(bào)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(chǎng)訪問(wèn)和/或其他與試驗(yàn)有關(guān)的交流后，根據(jù)申辦者的sop寫(xiě)給申辦者的書(shū)面報(bào)告。1.40 multicentre trial 多中心試驗(yàn)a clinical trial conducted accord

54、ing to a single protocol but at more than one site, and therefore, carried out by more than one investigator. 按照一個(gè)試驗(yàn)方案，在一個(gè)以上試驗(yàn)單位實(shí)施，因此由一名以上研究者完成的臨床試驗(yàn)。1.41 nonclinical study 非臨床試驗(yàn)biomedical studies not performed on human subjects. 不是在人類(lèi)對(duì)象進(jìn)行的生物醫(yī)學(xué)研究。1.42 opinion (in relation to independent ethics commit

55、tee) 意見(jiàn)（與獨(dú)立的倫理委員會(huì)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(huì)（iec）給出的評(píng)價(jià)和/或建議1.43 original medical record 原始醫(yī)學(xué)記錄see source documents. 見(jiàn)源文件1.44 protocol 試驗(yàn)方案a document that describes the objective(s), design, methodology, statistical considerations, a

56、nd 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(gè)闡明試驗(yàn)的目的、設(shè)計(jì)、方法學(xué)、統(tǒng)計(jì)學(xué)考慮和組織的文件。試驗(yàn)方案

57、通常也給出試驗(yàn)的背景和理論基礎(chǔ)，但者這可以寫(xiě)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(yàn)方案這一術(shù)語(yǔ)指試驗(yàn)方案和方案的修改。1.45 protocol amendment 試驗(yàn)方案的修改a written description of a change(s) to or formal clarification of a protocol. 對(duì)試驗(yàn)方案的改變或澄清的書(shū)面描述。1.46 quality assurance (qa) 質(zhì)量保證（qa）all those planned and systematic actions that are established to ensur

58、e 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(yàn)的進(jìn)行和數(shù)據(jù)產(chǎn)生、記錄以及報(bào)告都符合臨床試驗(yàn)管理規(guī)范（gcp）和適用管理要求所建立的有計(jì)劃的系統(tǒng)活動(dòng)。1.47 quality control (qc) 質(zhì)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. 在質(zhì)量保證系統(tǒng)內(nèi)所采取的操作技術(shù)和活動(dòng)，以查證與試驗(yàn)相關(guān)的活動(dòng)都符合質(zhì)量要求。1.48 randomization 隨機(jī)