ICH-GCP中英文对照（完整） - 图文 

source documents.

试验方案需要的数据在ＣＲＦ上有准确记录，并与源文件一致

ii) Any dose and/or therapy modifications are well documented for each of the trial subjects. 每一位试验对象的剂量和治疗的任何修改均与有良好记录

iii) Adverse events, concomitant medications and intercurrent illnesses are reported in accordance with the protocol on the CRFs. 不良事件，伴随用药和试验过程中发生的疾病根据方案在CRF上作了报告

iv) Visits that the subjects fail to make, tests that are not conducted, and examinations that are not performed are clearly reported as such on the CRFs. 试验未来随访，未进行的检验，未完成的检查应同样在CRF上有清楚报告

v) All withdrawals and dropouts of enrolled subjects from the trial are reported and explained on the CRFs. 已接纳对象的撤出或中途退出试验应在CRF上报告并给出说明

n) Informing the investigator of any CRF entry error, omission, or illegibility. The monitor should ensure that appropriate corrections, additions, or deletions are made, dated, explained (if necessary), and initialled by the investigator or by a member of the investigator's trial staff who is authorized to initial CRF changes for the investigator. This authorization should be documented. 通知研究者关于CRF的填写错误、遗漏或字迹不清楚。监察员应当确保所做的更正、附加或删除是合宜的、注明日期的、有说明的（如有必要），并由研究者或研究者授权修正的ＣＲＦ的试验工作人员签上姓名首字母。授权应当有证明。

o) Determining whether all adverse events (AEs) are appropriately reported within the time periods required by GCP, the protocol, the IRB/IEC, the sponsor, and the applicable regulatory requirement(s). 确定是否所有不良事件(AE)在GCP、试验方案、IRB/IEC、申办者和适用管理要求所规定的期限内恰当地作了报告。

p) Determining whether the investigator is maintaining the essential documents (see 8. Essential Documents for the Conduct of a Clinical Trial). 确定研究者是否保持有基本文件(见8.实施临床试验地基本文件)

q) Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator and taking appropriate action designed to prevent recurrence of the detected deviations. 通知研究者关于与试验方案、SOP、GCP和适用管理要求地偏离，并采取适当措施防止再发生上述偏离。

5.18.5 Monitoring Procedures

监查程序

The monitor(s) should follow the sponsor’s established written SOPs as well as those procedures that are specified by the sponsor for monitoring a specific trial.

监察者应当遵循申办者制订地各种SOP以及申办者为监察一个特定试验制订地特定程序。 5.18.6 Monitoring Report 监查报告

a) The monitor should submit a written report to the sponsor after each trial-site visit or trial-related communication. 监察者在每一次进行试验单位现场访问或与试验有关地交流后，应当向申办者递交书面报告。 b) Reports should include the date, site, name of the monitor, and name of the investigator or other individual(s) contacted. 报告应当包括日期、地点、监察者姓名、研究者或接触地其他人员的姓名

c) Reports should include a summary of what the monitor reviewed and the monitor's statements concerning the significant findings/facts, deviations and deficiencies, conclusions, actions taken or to be taken and/or actions recommended to secure compliance. 报告应当包括监察者检查内容的摘要，监察员关于有意义发现/事实的陈述，偏离和不足，结论，已采取的或将采取的措施，和/或为保护依从性建议的措施。

d) The review and follow-up of the monitoring report with the sponsor should be documented by the sponsor’s designated representative. 申办者对监察报告的审评和随访应当有申办者制订的代表作成文件

5.19 Audit 稽查

If or when sponsors perform audits, as part of implementing quality assurance, they should consider: 作为实现质量保证的一部分，申办者进行稽查时应当考虑 5.19.1 Purpose

目的

The purpose of a sponsor's audit, which is independent of and separate from routine monitoring or quality control functions, should be to evaluate trial conduct and compliance with the protocol, SOPs, GCP, and the applicable regulatory requirements.

独立的、与常规监察或质量控制分开的申办者的稽查，其目的应当是评价试验的实施和对试验方案、SOP、GCP和适用管理要求的依从性 5.19.2 Selection and Qualification of Auditors

稽查员的选择和资格

a) The sponsor should appoint individuals, who are independent of the clinical trials/systems, to conduct

audits.

申办者应当指定一个独立于临床试验/体系的人实施稽查

b) The sponsor should ensure that the auditors are qualified by training and experience to conduct audits properly. An auditor’s qualifications should be documented. 申办者应当保证稽查员是通过培训合格并有经验正确的实施稽查。稽查员的资格应当有证明。

5.19.3 Auditing Procedures

稽查程序

The sponsor should ensure that the auditing of clinical trials/systems is conducted in accordance with the sponsor's written procedures on what to audit, how to audit, the frequency of audits, and the form and content of audit reports.

申办者应当保证临床试验/体系是按照申办者的关于稽查什么、如何稽查、稽查频度的书面程序、稽查报告表及其内容进行

a) The sponsor's audit plan and procedures for a trial audit should be guided by the importance of the trial to submissions to regulatory authorities, the number of subjects in the trial, the type and complexity of the trial, the level of risks to the trial subjects, and any identified problem(s). 申办者方对一个试验稽查的稽查计划和程序应当根据试验对于向管理当局提交的重要性、试验中的对象数目、试验的类型和复杂成都、试验对象的风险水平以及所识别的其他问题而定。 b) The observations and findings of the auditor(s) should be documented. 稽查的观察资料和发现应当做成文件

c) To preserve the independence and value of the audit function, the regulatory authority(ies) should not routinely request the audit reports. Regulatory authority(ies) may seek access to an audit report on a case by case basis when evidence of serious GCP non-compliance exists, or in the course of legal proceedings. 未保持稽查职能的独立性和价值，管理当局不应当例行公事地要求稽查报告。当有严重不依从GCP地证据存在时，或在法律诉讼期间，管理当局可能寻求逐例试验稽查报告。 d) When required by applicable law or regulation, the sponsor should provide an audit certificate. 在适用法律或法规要求，申办者应当提供稽查许可证。

5.20 Noncompliance 不依从性

5.20.1 Noncompliance with the protocol, SOPs, GCP, and/or applicable regulatory requirement(s) by an

investigator/institution, or by member(s) of the sponsor's staff should lead to prompt action by the sponsor to secure compliance.

一个研究者/研究机构或申办者的职员对于试验方案、SOP、GCP和/或适用管理要求不依从时，申办者应当立即采取措施促成依从性。

5.20.2 If the monitoring and/or auditing identifies serious and/or persistent noncompliance on the part of an

investigator/institution, the sponsor should terminate the investigator's/institution’s participation in the trial. When an investigator's/institution’s participation is terminated because of noncompliance, the sponsor should notify promptly the regulatory authority(ies).

如果监察和/研究机构的某一部门严重的和/或持续的不依从，申办者应当停止研究者/研究机构参加临床试验。一个研究者/研究机构因为不依从被终止参加试验时，申办者应当立即通报管理当局。

5.21 Premature Termination or Suspension of a Trial

一个试验的过早终止或暂停

If a trial is prematurely terminated or suspended, the sponsor should promptly inform the investigators/ institutions, and the regulatory authority(ies) of the termination or suspension and the reason(s) for the termination or suspension. The IRB/IEC should also be informed promptly and provided the reason(s) for the termination or suspension by the sponsor or by the investigator/institution, as specified by the applicable regulatory requirement(s).

如果一个试验过早终止或停止，申办者应当立即通知各研究者/研究机构以及管理当局关于终止或暂停事宜及其理由。根据适用管理要求的说明，申办者或研究者/研究机构还应当立即通知IRB/IEC并提供终止或暂停的理由。

5.22 Clinical Trial/Study Reports 临床试验/研究报告

Whether the trial is completed or prematurely terminated, the sponsor should ensure that the clinical trial reports are prepared and provided to the regulatory agency(ies) as required by the applicable regulatory requirement(s). The sponsor should also ensure that the clinical trial reports in marketing applications meet the standards of the ICH Guideline for Structure and Content of Clinical Study Reports. (NOTE: The ICH Guideline for Structure and Content of Clinical Study Reports specifies that abbreviated study reports may be acceptable in certain cases.)

不管临床试验是完成了还是过早停止，申办者应当确保按照适用管理规定要求准备临床试验报告，并提供给管理部门。申办者也应当保证，上市申请的临床试验报告符合《ICH临床研究报告的结构和内容指导原则》的标准。（注：《ICH临床研究报告的结构和内容指导原则》说明了在某些情况下 间断的研究报告是可接受的。

5.23 Multicentre Trials 多中心试验

For multicentre trials, the sponsor should ensure that: 对于多中心试验，申办者应当保证：

5.23.1 All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor and, if

required, by the regulatory authority(ies), and given approval/favourable opinion by the IRB/IEC.

实施试验的所有研究者严格遵循申办者同意的、必要时经管理当局同意并得到IRB/IEC批准/赞成意见的试验方案。

5.23.2 The CRFs are designed to capture the required data at all multicentre trial sites. For those investigators

who are collecting additional data, supplemental CRFs should also be provided that are designed to capture the additional data.

在多中心研究中，CRF被设计用来记录所需要的数据。对于那些收集附加数据的研究者，应向他们提供设计来用于收集额外数据的补充CRF

5.23.3 The responsibilities of coordinating investigator(s) and the other participating investigators are

documented prior to the start of the trial.

协调研究者和其他主要研究者的职责要在试验开始前确认

5.23.4 All investigators are given instructions on following the protocol, on complying with a uniform set of

standards for the assessment of clinical and laboratory findings, and on completing the CRFs.

向所有研究者提供关于理解试验方案、遵循评价临床和实验室发现的同意标准以及完成CRF的指导性原则

5.23.5 Communication between investigators is facilitated.

促进研究者之间的交流

6. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)

临床试验方案和方案增补

The contents of a trial protocol should generally include the following topics. However, site specific information may be provided on separate protocol page(s), or addressed in a separate agreement, and some of the information listed below may be contained in other protocol referenced documents, such as an Investigator’s Brochure.

试验方案的内容通常应当包括以下主题。但是试验单位的特别信息可以分开列在方案的单独一（几）页上，或写在一个单独的协议中，下列的某些资料可写在方案的其他参考文件，如研究者手册中。

6.1 General Information 一般资料

6.1.1 Protocol title, protocol identifying number, and date. Any amendment(s) should also bear the

amendment number(s) and date(s).

试验方案的题目，方案鉴别号和日期。任何修改应当有修改编号和日期 6.1.2 Name and address of the sponsor and monitor (if other than the sponsor).

申办者和监察员（如与申办者非同一个人）的姓名和地点

6.1.3 Name and title of the person(s) authorized to sign the protocol and the protocol amendment(s) for the

sponsor.

被授权为研究者签署试验方案和方案修改人员的姓名和头衔

6.1.4 Name, title, address, and telephone number(s) of the sponsor's medical expert (or dentist when