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