4.8.7 Before informed consent may be obtained, the investigator, or a person designated by the investigator,
should provide the subject or the subject's legally acceptable representative ample time and opportunity to inquire about details of the trial and to decide whether or not to participate in the trial. All questions about the trial should be answered to the satisfaction of the subject or the subject's legally acceptable representative.
在可能得到知情同意之前，研究者或研究者指定的人应当让对象或对象的合法接受代表有充足的时间和机会询问关于试验的详细情况和决定是否参加试验。应当回答所有问题，让对象或对象的合法可接受代表满意。
4.8.8 Prior to a subject’s participation in the trial, the written informed consent form should be signed and
personally dated by the subject or by the subject's legally acceptable representative, and by the person who conducted the informed consent discussion.
在对象参加试验之前，对象或对象的合法可接受代表以及执行知情同意讨论的人应亲自前述知情同意书并注明日期。
4.8.9 If a subject is unable to read or if a legally acceptable representative is unable to read, an impartial
witness should be present during the entire informed consent discussion. After the written informed consent form and any other written information to be provided to subjects, is read and explained to the subject or the subject’s legally acceptable representative, and after the subject or the subject’s legally acceptable representative has orally consented to the subject’s participation in the trial and, if capable of doing so, has signed and personally dated the informed consent form, the witness should sign and personally date the consent form. By signing the consent form, the witness attests that the information in the consent form and any other written information was accurately explained to, and apparently understood by, the subject or the subject's legally acceptable representative, and that informed consent was freely given by the subject or the subject’s legally acceptable representative.
如果一名对象不能阅读，或一位合法可接受的代表不能阅读，在整个知情同意讨论期间必需有一位合法可接受的代表不能在书面的知情同意书和其他文件资料交给对象后，向对象或对象的合法可接受代表进行阅读并解释，在对象或对象的合法可接受代表已经口头同意对象参加试验、并且如果可能已在知情同意书上签字并注明日期。见证人通过签署知情同意书证明，知情同意书和其他文字资料已被准确的向对象或对象的合法可接受代表作了解释，对象或对象的合法可接受代表显然懂得这些解释，知情同意是对象或对象的合法可接受代表自由的给出的。
4.8.10 Both the informed consent discussion and the written informed consent form and any other written
information to be provided to subjects should include explanations of the following:
知情同意讨论和提供给对象的书面的知情同意书以及其他文字资料应当包括以下问题的解释： a) That the trial involves research. 试验涉及的研究
b) The purpose of the trial. 试验目的
c) The trial treatment(s) and the probability for random assignment to each treatment. 试验治疗和随机分配到各种治疗的可能性
d) The trial procedures to be followed, including all invasive procedures. 试验就行的程序，包括所有侵袭性程序
e) The subject's responsibilities. 对象的责任
f) Those aspects of the trial that are experimental. 试验的实验方面性
g) The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus, or nursing infant. 带给对象、可能时带给胚胎、胎儿或哺乳婴儿的合理预见的危险或不方便。
h) The reasonably expected benefits. When there is no intended clinical benefit to the subject, the subject should be made aware of this. 可合理预见的受益。不存在预期的临床受益时，对象应当知道这一点。
i) The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important potential benefits and risks. 对象可能得到的可替代治疗程序或过程，以及这些治疗的重要潜在受益和风险。 j) The compensation and/or treatment available to the subject in the event of trial-related injury. 在与试验相关的伤害事件中对象可获得的补偿和/治疗。
k) The anticipated prorated payment, if any, to the subject for participating in the trial. 给参加试验对象的预期按比例分配的支付（如果有）
l) The anticipated expenses, if any, to the subject for participating in the trial. 对象因参加试验的预期花费（如果有）
m) That the subject's participation in the trial is voluntary and that the subject may refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise entitled. 对象参加试验是自愿的，对象可以拒绝参加试验，或在任何时候退出试验而不会收到出发或损失本来对象有权利得到的利益。
n) That the monitor(s), the auditor(s), the IRB/IEC, and the regulatory authority(ies) will be granted direct access to the subject's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the subject or the subject's legally acceptable representative is authorizing such access. 监察员、稽查员、IRB/IEC和管理当局将被准予在不违反对象的保密性、在适用法律与规定准许的程度直接访问对象的原始医学记录以查证临床试验程序和/或数据，对象或对象的合法可接受的代表通过签署书面的知情同意书授权这种访问。
o) That records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. If the results of the trial are published, the subject’s identity will remain confidential.
在适用法律和/或规定允许的范围，能鉴别对象的记录应保密，不得公开这些记录。如果试验结果发表，对象鉴别仍然是保密的。
p) That the subject or the subject's legally acceptable representative will be informed in a timely manner if information becomes available that may be relevant to the subject's willingness to continue participation in the trial. 如果得到与对象继续参加试验的愿望可能相关的资料，对象或对象的合法可接受代表将得到及时通报。
q) The person(s) to contact for further information regarding the trial and the rights of trial subjects, and whom to contact in the event of trial-related injury. 需要进一步了解有关试验资料和试验对象的权利时的联系人，以及在发生与试验有关的伤害时的联系人。
r) The foreseeable circumstances and/or reasons under which the subject's participation in the trial may be terminated. 对象参加试验可能被终止的可预见情况和/或理由
s) The expected duration of the subject's participation in the trial. 对象参加试验的预期持续时间
t) The approximate number of subjects involved in the trial. 参加试验对象的大约人数
4.8.11 Prior to participation in the trial, the subject or the subject's legally acceptable representative should
receive a copy of the signed and dated written informed consent form and any other written information provided to the subjects. During a subject's participation in the trial, the subject or the subject’s legally acceptable representative should receive a copy of the signed and dated consent form updates and a copy of any amendments to the written information provided to subjects.
在参加试验前，对象或对象的合法可接受代表应收到一份已签署并注明日期的书面知情同意书的复印件和其他提供给对象的书面资料。对象参加试验期间，对象或对象的合法可接受代表应收到已签署并注明日期的知情同意书的更新的复印件和提供给对象的书面资料的修改文本。
4.8.12 When a clinical trial (therapeutic or non-therapeutic) includes subjects who can only be enrolled in the
trial with the consent of the subject’s legally acceptable representative (e.g., minors, or patients with severe dementia), the subject should be informed about the trial to the extent compatible with the subject’s understanding and, if capable, the subject should sign and personally date the written informed consent.
当一个临床试验（治疗的或非治疗的）包括那些职能由其合法可接受代表表示进入试验的对象时（如未成年人，或严重痴呆病人），应当在对象能理解的程度告知对象关于试验的信息。如果可能，对象应当亲自签署书面的知情同意并注明日期。
4.8.13 Except as described in 4.8.14, a non-therapeutic trial (i.e. a trial in which there is no anticipated direct
clinical benefit to the subject), should be conducted in subjects who personally give consent and who sign and date the written informed consent form.
除非如4.8.14所描述的情况外，一个非治疗试验（如对于对象没有可预期的直接临床好处的试验）应当在那些亲自同意并在书面的知情同意书上签字和注明日期的对象中进行。
4.8.14 Non-therapeutic trials may be conducted in subjects with consent of a legally acceptable representative
provided the following conditions are fulfilled:
只要符合下列条件，非治疗试验可以在由合法可接受代表同意的对象中进行：
a) The objectives of the trial can not be met by means of a trial in subjects who can give informed consent personally. 试验的目的不能通过在能亲自给出知情同意的对象中进行的试验达到。 b) The foreseeable risks to the subjects are low. 对象的可预见风险很低
c) The negative impact on the subject’s well-being is minimized and low. 对于对象健康的负面影响被减到最小，并且是最低的 d) The trial is not prohibited by law. 法律不禁止该试验
e) The approval/favourable opinion of the IRB/IEC is expressly sought on the inclusion of such subjects, and the written approval/ favourable opinion covers this aspect.
明确的寻求IRB/IEC对接纳这些对象的批准/赞成意见；书面的批准/赞成意见同意接纳这些对象。 Such trials, unless an exception is justified, should be conducted in patients having a disease or condition for which the investigational product is intended. Subjects in these trials should be particularly closely monitored and should be withdrawn if they appear to be unduly distressed.
除非被证明是一个例外，这类试验应当在具有预期适用试验用药品的疾病或状况的病人中进行。这些试验中对象应当受到特别的密切检查，如果他们显得过分痛苦，应当退出试验。
4.8.15 In emergency situations, when prior consent of the subject is not possible, the consent of the subject's
legally acceptable representative, if present, should be requested. When prior consent of the subject is not possible, and the subject’s legally acceptable representative is not available, enrolment of the subject should require measures described in the protocol and/or elsewhere, with documented approval/favourable opinion by the IRB/IEC, to protect the rights, safety and well-being of the subject and to ensure compliance with applicable regulatory requirements. The subject or the subject's legally acceptable representative should be informed about the trial as soon as possible and consent to continue and other consent as appropriate (see 4.8.10) should be requested.
在紧急情况下，不可能事先得到对象的知情同意时，应该请求对象的合法可接受代表（如果在场）的同意。当对象的接纳需要按方案和/或其他文件中描述的、得到IRB/IEC的书面批 准/赞成意见的方法进行，以保护对象的权利、安全和健康，并保证依从适用的管理要求。应尽可能地通知对象或
对象地合法可接受代表关于试验地事，并应得到他们继续参加试验和 其他事项（见4.8.10）的知情同意。
4.9 Records and Reports 记录和报告
4.9.1 The investigator should ensure the accuracy, completeness, legibility, and timeliness of the data reported
to the sponsor in the CRFs and in all required reports.
研究者应当保证给申办者的病历报告表（ＣＲＦ）和所有需要的报告中的数据的准确性、完整性、易辩性和及时性。
4.9.2 Data reported on the CRF, that are derived from source documents, should be consistent with the source
documents or the discrepancies should be explained.
ＣＲＦ中来自源文件的数据应当与源文件一致，如由不一致应作出解释。
4.9.3 Any change or correction to a CRF should be dated, initialed, and explained (if necessary) and should not
obscure the original entry (i.e. an audit trail should be maintained); this applies to both written and electronic changes or corrections (see 5.18.4 (n)). Sponsors should provide guidance to investigators and/or the investigators' designated representatives on making such corrections. Sponsors should have written procedures to assure that changes or corrections in CRFs made by sponsor's designated representatives are documented, are necessary, and are endorsed by the investigator. The investigator should retain records of the changes and corrections.
ＣＲＦ中数据的任何改变或变更，应当注明日期、姓名首字母和说明（如有必要），并应当使原来的记录依然可见（即应保留核查痕迹）；这同样适用于文字和电子的改变或更正（见5.18.4（ｎ））。申办者应当向研究者和/或研究者指定的代表提供关于进行这种更正的指南。申办者应当有书面的程序以保证在CRF中由申办者指定的代表作出的改变或更正是有记录的、有必要的，并得到研究者的认可。研究者应当保留改变和更正的记录。
4.9.4 The investigator/institution should maintain the trial documents as specified in Essential Documents for
the Conduct of a Clinical Trial (see 8.) and as required by the applicable regulatory requirement(s). The investigator/institution should take measures to prevent accidental or premature destruction of these documents.
研究者/研究机构应当按《实施临床试验的基本文件》（见8.）所述和适用管理要求保存试验文件。研究者/研究机构应当采取措施防止这些文件的以外或过早破坏。
4.9.5 Essential documents should be retained until at least 2 years after the last approval of a marketing
application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least 2 years have elapsed since the formal discontinuation of clinical development of the investigational product. These documents should be retained for a longer period however if required by the applicable regulatory requirements or by an agreement with the sponsor. It is the responsibility of the sponsor to inform the investigator/institution as to when these documents no longer need to be retained (see 5.5.12).
基本文件应当保留到最后批准在一个ＩＣＨ地区上市后至少2年，和直到最后在一个ＩＣＨ地区没有未决的或仍在考虑的上市应用，或试验用药品的临床研究正式停止后至少已过去2年。但是，如
ICH-GCP中英文对照（完整） - 图文
