ICH三方協(xié)調(diào)指導(dǎo)原則E6ICHGCP【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-az- 1.刖呂good clin ical practice (gcp) is an in ternational ethical and scientific quality stan dard for designing, conducting, recording and reporting trials that involve the participation of human subjects. compliance with this standard provides public assurane

2、e 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.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

3、試驗(yàn)數(shù)據(jù)的可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 acceptanee of clinical data by the regulatory authorities in these jurisdictions.ich-gcp指導(dǎo)原則的目的是為歐盟、fl木和美國(guó)提供統(tǒng)-的標(biāo)準(zhǔn)，以促進(jìn)這些管理當(dāng)局在其 權(quán)限內(nèi)

4、相互接受臨床數(shù)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).木指導(dǎo)原則的發(fā)展考慮了歐盟、日木、美國(guó)，以及澳人利亞、加拿人、北歐國(guó)家和世界一衛(wèi)生 組織(who)的現(xiàn)行

5、gcp。this 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 an

6、d well-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(duì)象安全利健廉的其他臨床研究。1. glossary1. 術(shù)語(yǔ)1.1 adverse drug reaction (adr) 藥品不良反j's (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 medici nal product mea ns that a causal relati on ship betwee n a medici nal product and an adverse eve nt is at least a reasonable possibility, i.e. the relati on

8、 ship cannot be ruled out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)z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 n ormally used in man for prop

9、hylaxis, diag no sis, 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).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 ev

10、ent (ae)不良事件(ae)any untoward medical occurrenee in a patient or clinical investigation subject administered a pharmaceutical product and which does not n ecessarily have a causal relati on ship with this treatme nt. an adverse eve nt (ae) can therefore be any un favourable and unin tended sign (incl

11、uding 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 expedite

12、d report!ng).在用藥病人或臨床研究對(duì)象中發(fā)生的任何不幸醫(yī)療事件，他不一定要與治療冇因果關(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冇關(guān)(參見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.見試驗(yàn)方案修改1.4 applicable regulatory requirement(s)適用的管理要求any law(s) and regulati

13、 on(s) addressi ng the con duct of clin ical trials of investigatio nal 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 withi

14、n the constraints set forth by the irb, 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 in depe ndent exami nation of trial related activities and documents to determi

15、ne whether the evaluated trial related activities were con ducted, 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).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

16、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(sop)、臨床試驗(yàn)管理規(guī)范(gcp)以及適用 的管理要求。1.7 audit certificate 稍查證書a declaration of confirmation by the auditor that an audit has taken place.稽杳員確認(rèn)已進(jìn)行稽杳的聲明。1.8 audit report 稽查報(bào)告a written evaluation by the sponsor's auditor of the results of the audit.申辦者方稽杏關(guān)于稽杏結(jié)果的

17、書面評(píng)價(jià)1.9 audit trail 稽査軌跡docume ntati on that allows rec on structi on of the course of eve nts.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,

18、and double-blinding usually refers to the subject(s), investigator(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 el

19、ectronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.設(shè)計(jì)用來(lái)記錄試驗(yàn)方案要求向屮辦者報(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, pharmacol

20、ogical 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

21、/or efficacy the terms clinical trial and clinical study are synonymous在人類対象進(jìn)行的任何意在發(fā)現(xiàn)或證實(shí)一種試驗(yàn)用藥甜的臨床、藥理學(xué)和/或其他藥效學(xué)作 川；和/或確定一種試驗(yàn)川藥品的任何不良反應(yīng)；和/或研究-種試驗(yàn)川藥品的吸收、分布、 代謝和排淞，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, prophy

22、lactic, 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 conte nt of clinical study reports).在人類對(duì)象進(jìn)行的任何治療、預(yù)防或診斷劑的試驗(yàn)/研究的書面描述。臨床和統(tǒng)計(jì)描述、陳 述和分析

23、全部列入該單份報(bào)告(見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)照(藥物)an investigational or marketed product (i.e., active control), or placebo, used as a referenee 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 requir

24、ements, good clinical practice (gcp) requirements, and the 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 sponsort proprietary information or of a subject's identity.不得向耒經(jīng)授權(quán)的個(gè)人泄漏

25、中辦者所有的資料或?qū)﹀璧纳矸荨?.17 contract 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 fin ancial matters the protocol may serve as the basis of a con tract.在兩個(gè)或兒個(gè)有關(guān)方之間的

26、一份書面的、有h期和簽字的協(xié)議，具屮陳述了關(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)方案可以作為介同的棊礎(chǔ)。1.18 coordinating committee 協(xié)調(diào)委員會(huì)a committee that a spon sor may orga nize to coordi nate the con duct of a multice ntre trial.中辦者組織的協(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 coo

27、rdination of investigators at different centres participating in a 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) 合同研究纟ii.織a person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's tri

28、al-related duties and functions.與中辦者訂立契約完成一個(gè)或多個(gè)有關(guān)中辦者方的試驗(yàn)任務(wù)和功能的個(gè)人或組織(商業(yè)性的, 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, s

29、pon sor's mon itors and auditors) with direct access should take all reas on able precauti ons withi n the constrai nts of the applicable regulatory requireme nt(s) to maintain the con fide ntiality of subjects' identities and sponsor's 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

30、義的記錄和報(bào)告。宜接訪問(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 缺站，采取一切合理的預(yù)防措施維護(hù)對(duì)彖身份和中辦者資料的保密性。1.22 documentation 文件all records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and sea ns, x-rays, and electrocardiograms) that describe or record the methods, con

31、 duct, 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/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(包括但不限于書面、電了、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docume nts which in dividually and collectively permit evaluatio n of the con duct of a study and the qu

32、ality of the data produced (see 8. esse ntial docume nts for the con duct of a clin ical trial). 指各口和合在一起允許評(píng)價(jià)一個(gè)研究的執(zhí)行悄況和所得數(shù)據(jù)的質(zhì)量文件(見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, con duct, performa nc© mon itoring, auditi ng, recording, an alyses, and rep

33、orting of clinical trials that provides assuranee that the data and reported results are credible and accurate, and that the rights, integrity, and con fide ntiality 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)彖的權(quán)利、完整性和機(jī)密性。1.25 independent data-moni

34、toring 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)(idmc)(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 da

35、ta, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.由申辦者設(shè)立一彳、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 公平的見證人a pers on, who is independe nt of the trial, who cannot be un fairly in flue need by pe

36、ople in volved with the trial, who attends the in formed 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.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?表人不能閱

37、讀，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和其他 書面資料。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 committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure th

38、e protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assuranee 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 t

39、he methods and material to be used in obtaining and documenting informed consent of the trial subjects.一個(gè)由醫(yī)學(xué)專業(yè)人員和非庾學(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)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)対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)作用的意見以對(duì)這種保護(hù)提供公眾保證the legal status, composition, function, oper

40、ations 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)、操作和適川的管理要求口j能不 川，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 in

41、formed consent 知情同意a process by which a subject voluntarily con firms his or her willingn ess to participate in a particular trial, after havi ng bee n in formed of all aspects of the trial that are releva nt to the subject's decisi on to participate .in formed consent is docume nted by mea ns o

42、f a writte n, signed and dated in formed 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。知情同意采用帖面的、簽字并注明日期的知情同意書。1.29 inspection 視察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 aut

43、hority(ies) to be related to the clin ical trial and that may be located at the site of the trial, at the sponsor's an d/or con tract research organization's (cro's) 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)

44、的英他機(jī)構(gòu)対其認(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 en tity or agency or medical or den tai facility where clin ical trials are con ducted.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)就。1.31 institutional review board (irb)機(jī)構(gòu)審評(píng)委員會(huì)(irb)an independent body constituted of med

45、ical, scientific, and nonscientific 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 a

46、nd material to be used in obtaining and docume nting in formed conse nt of the trial subjects.由庾學(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)方案及英修訂木，獲 得受試對(duì)彖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) 彖的權(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 in termediate results and their evaluati on b

47、ased on an alyses performed duri ng the course of a trial.根據(jù)試驗(yàn)進(jìn)行過(guò)程屮所做的分析寫出的屮期結(jié)杲和評(píng)價(jià)的報(bào)告1.33 investigational product 試驗(yàn)用藥品a pharmaceutical form of an active in gredie nt or placebo being tested or used as a ref ere nee in a clinical trial, including a product with a marketing authorization when used or

48、 assembled (formulated or packaged) in a way d iff ere nt from the approved form, or when used for an un approved in dicati on, or when used to gain further in formation about an approved use.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)耒經(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 invest

49、igator 研究者a pers on responsible for the con duct of the clin ical trial at a trial site. if a trial is con ducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. see also subinvestigator.負(fù)責(zé)在一個(gè)試驗(yàn)單位實(shí)施臨床試驗(yàn)的人。

50、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，也稱為主要研究者。見次級(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 requirements”.表示“符合適用管理要求的研究者和/或研究機(jī)構(gòu)”1.36 investigator's brochure 研究者手冊(cè)a compilati on of the clin

51、ical and non clinical data on the in vestigati onal product(s) which is relevant to the study of the investigational product(s) in human subjects (see 7. investigator's brochure).與試驗(yàn)藥品在人類對(duì)象屮的研究有關(guān)的臨床和非臨床資料的匯編(見7.研究者手冊(cè))1.37 legally acceptable representative法律上可接受的代表an in dividual or juridical or o

52、ther body authorized un der applicable law to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial.在適用法律卜被授權(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 overseei ng the progress of a clin ical trial, and of en suri ng that it is con du

53、cted, recorded, and reported in accordanee 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(gcp)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 mo

54、nitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor's 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)的交流示，根據(jù)屮辦者的sop寫給屮辦者的 書面報(bào)告。1.40 multicentre trial 多中心試驗(yàn)a clin ical trial con ducted accordi ng to a single protocol but at more tha n one site, and therefore, ca

55、rried 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-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不是在人類對(duì)象進(jìn)行的生物醫(yī)學(xué)研究。1.42 opinion (in relation to independent ethics committee)意見(與獨(dú)立的倫理委員會(huì)相關(guān))the judgement and/or the advice provided by an indepe

56、ndent 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.見源文件1.44 protocol試驗(yàn)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 a

57、nd rationale for the trial, but these could be provided in other protocol ref ere need docume nts. 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)方案通常也給出試驗(yàn) 的背景和理論基礎(chǔ)，但者這可以寫在與方案有關(guān)的其他參考文件屮。在ich指導(dǎo)原則屮，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

58、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 that the trial is performed and the data are gen erated, docume nted (rec

59、orded), and reported in complia nee 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 f