研究者应当充分熟悉在试验方案、研究者手册、产品自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.
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).
研究者/研究机构应当允许申办者的监察和稽查，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.
研究者应当有一份合适资格、并已委派给他们与试验相关的和总要任务的人员名单。
4.2 Adequate Resources 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.
研究者应能证明（如根据遗忘的数据）在协议的招募期内接纳所需要数目的合适对象的可能性。 4.2.2 The investigator should have sufficient time to properly conduct and complete the trial within the agreed
trial period.
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.
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争取、安全的实施试验。 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.
研究者应当保证所有的试验辅助人员已充等了解试验方案，试验用药品，及他们与试验相关的责任和职能。
4.3 Medical Care of Trial Subjects 试验对象的医疗
4.3.1 A qualified physician (or dentist, when appropriate), who is an investigator or a sub-investigator for the
trial, should be responsible for all trial-related medical (or dental) decisions.
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.
在对象参加一个试验期间或以后，研究者/研究机构应当保证为对象的任何不良反应，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。研究者知道并发疾病需要医疗保健时，研究者/研究机构应当通知对象。
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.
如果对象有初级医生并且对象同意让初级医生知道，建议研究者将对象参加试验的事通知对象的初级医生。
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.
尽管一名对象没有义务给出他/她中途退出试验的理由，研究者仍应当在充分尊重对象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 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.
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）、以及提供给对象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.
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提供研究者手册的当前文本。如果研究者手册在试验中更新，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.
在试验期间，研究者/研究机构应当向IRB/IEC提供全部供审评的文件。
4.5 Compliance with Protocol 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.
研究者/研究机构应当按照申办者和（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另立的合同上签字，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)).
研究者在没有取得申办者同意和事先得到IRB/IEC对于一个修改的审评与书面批准/赞成时，不应当偏离或改变方案，除非必需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（如更换监察员，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.
研究者，或由研究者指定的人，应当记录和解释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:
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尽可能地提交给： a) to the IRB/IEC for review and approval/favourable opinion,
IRB/IEC审评并得到批准/赞成
b) to the sponsor for agreement and, if required, 申办者征得同意和，如果需要 c) to the regulatory authority(ies). 管理当局
4.6 Investigational Product(s) 试验药品
4.6.1 Responsibility for investigational product(s) accountability at the trial site(s) rests with the
investigator/institution.
在试验单位，试验用药品计数地责任归于研究者/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..
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地/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.
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，每位对象的使用记录，和未使 用的药品交还给申办者或另法处置的记录。这些记录应包含日期、数量、批号/系列号、时效期（如有）、和分配给试验用药品和试验对象的特别编码。研究者应保持记载有按方案说 明给予对象药量的记录，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).
试验用药品应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.
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, or a person designated by the investigator/institution, should explain the correct use of
the investigational product(s) to each subject and should check, at intervals appropriate for the trial, that each subject is following the instructions properly.
研究者或研究者/研究机构指定的人，应当向每一位对象解释试验用药品的娥正确用法，并应在适合于该试验的一定间隔检查每一位对象完全遵照使用说明用药。
4.7 Randomization Procedures and Unblinding 随机程序和揭盲
The investigator should follow the trial's randomization procedures, if any, and should ensure that the code is broken only in accordance with the protocol. If the trial is blinded, the investigator should promptly document and explain to the sponsor any premature unblinding (e.g., accidental unblinding, unblinding due to a serious adverse event) of the investigational product(s).
研究者应当遵循试验的随机化程序（如果有），并应保证依照方案打开随机号码。如果试验采用盲法，研究者应当立即记录并向申办者解释试验用药品的任何提前破盲（如以外破盲，因严重不良事件破盲）。
4.8 Informed Consent of Trial Subjects 试验对象的知情同意
4.8.1 In obtaining and documenting informed consent, the investigator should comply with the applicable
regulatory requirement(s), and should adhere to GCP and to the ethical principles that have their origin in
the Declaration of Helsinki. Prior to the beginning of the trial, the investigator should have the IRB/IEC's written approval/favourable opinion of the written informed consent form and any other written information to be provided to subjects.
在获得和证明知情同意过程中，研究者应当遵循适用的管理规定，应当符合ＧＣＰ和源自赫尔辛基年宣言的伦理原则。在开始试验前，研究者应当有IRB/IEC对于书面的知情同意书和提供给对象的其他文字资料的书面批准/赞成意见。
4.8.2 The written informed consent form and any other written information to be provided to subjects should
be revised whenever important new information becomes available that may be relevant to the subject’s consent. Any revised written informed consent form, and written information should receive the IRB/IEC's approval/favourable opinion in advance of use. The subject or the subject’s legally acceptable representative should be informed in a timely manner if new information becomes available that may be relevant to the subject’s willingness to continue participation in the trial. The communication of this information should be documented.
无论何时得到与对象的知情同意可能相关的新的资料后，提供给对象的书面知情同意书和其他文字资料都应当进行修改。修改后的书面知情同意书和其他文字资料在适用前都应当得到IRB/IEC的批准/赞成。如果有与对象继续参加试验的愿望可能相关的新资料，应及时通知对象和对象的合法可接受代表。这种资料的交流应当被记录下来。
4.8.3 Neither the investigator, nor the trial staff, should coerce or unduly influence a subject to participate or
to continue to participate in a trial.
无论试验就人员还是试验职员，都不应强迫或不正当地影响一个对象参加或继续参加一个试验。 4.8.4 None of the oral and written information concerning the trial, including the written informed consent
form, should contain any language that causes the subject or the subject's legally acceptable representative to waive or to appear to waive any legal rights, or that releases or appears to release the investigator, the institution, the sponsor, or their agents from liability for negligence.
关于试验的口述或书面的资料，包括书面的知情同意书，都不应包含会引起对象或对象的合法可接受代表放弃或看来象是放弃任何合法利益的语言；或者免除或看来象是免除研究者、机构、申办者或他们的代理由于疏忽应负责任的语言。
4.8.5 The investigator, or a person designated by the investigator, should fully inform the subject or, if the
subject is unable to provide informed consent, the subject's legally acceptable representative, of all pertinent aspects of the trial including the written information and the approval/ favourable opinion by the IRB/IEC.
研究者或由研究者指定的人，至少应当告诉对象，或如果对象不能提供知情同意时告诉对象的合法可接受的代表，所有与试验相关的方面，包括文字资料和IRB/IEC的批准/赞成意见。
4.8.6 The language used in the oral and written information about the trial, including the written informed
consent form, should be as non-technical as practical and should be understandable to the subject or the subject's legally acceptable representative and the impartial witness, where applicable.
关于试验的口述和书面资料，包括书面知情同意书，所用的语言应当是非技术术语性的实用语言，对于对象或对象的合法可接受代表或公正的见证人应当是易懂的。
ICH-GCP中英文对照（完整） - 图文
