果适用的管理要求需要或申办者签署的协议需要，这些文件应当被保存更长时间。申办者有责任统制研究者/研究机构，到什么时候这些文件不必再保存（见5.5.12）
4.9.6 The financial aspects of the trial should be documented in an agreement between the sponsor and the
investigator/institution.
试验的财务方面事宜应在申办者与研究者/研究机构的协议书中说明。
4.9.7 Upon request of the monitor, auditor, IRB/IEC, or regulatory authority, the investigator/institution should
make available for direct access all requested trial-related records.
根据监察员、稽查员、IRB/IEC或管理当局的要求，研究者/研究机构应当提供他们查阅所需的与试验有关的全部记录。
4.10 Progress Reports 进展报告
4.10.1 The investigator should submit written summaries of the trial status to the IRB/IEC annually, or more
frequently, if requested by the IRB/IEC.
研究者应当每年一次，或应IRB/IEC要求的频度向IRB/IEC提交书面的试验情况摘要。
4.10.2 The investigator should promptly provide written reports to the sponsor, the IRB/IEC (see 3.3.8) and,
where applicable, the institution on any changes significantly affecting the conduct of the trial, and/or increasing the risk to subjects.
研究者应当迅速向申办者、IRB/IEC（见3.3.8）和（如果合适）向研究机构提供关于明显影响试验实施和/或增加对象风险的任何改变的书面报告。
4.11 Safety Reporting 安全性报告
4.11.1 All serious adverse events (SAEs) should be reported immediately to the sponsor except for those SAEs
that the protocol or other document (e.g., Investigator's Brochure) identifies as not needing immediate reporting. The immediate reports should be followed promptly by detailed, written reports. The immediate and follow-up reports should identify subjects by unique code numbers assigned to the trial subjects rather than by the subjects' names, personal identification numbers, and/or addresses. The investigator should also comply with the applicable regulatory requirement(s) related to the reporting of unexpected serious adverse drug reactions to the regulatory authority(ies) and the IRB/IEC.
除了试验方案或其他文件（如研究者手册）认为不必即时报告的那些严重不良事件（ＳＡＥ）以外，所有ＳＡＥ都应当立即向申办者报告。即时报告应理解为迅速的详细书面报告。即时和随访报告中的对象鉴别应当采用采用指定给试验对象的独特号码，而不是对象姓名、个人身份号码和/或地址。研究者还应当服从关于管理当局和IRB/IEC报告非预期的药物严重不良反应的适用管理要求。 4.11.2 Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations
should be reported to the sponsor according to the reporting requirements and within the time periods specified by the sponsor in the protocol.
在试验方案中被确定为对安全性评价是关键的不良事件和/或实验室异常应当按照报告要求和申办者在方案中说明的时限内向申办者报告。
4.11.3 For reported deaths, the investigator should supply the sponsor and the IRB/IEC with any additional
requested information (e.g., autopsy reports and terminal medical reports).
对于所报告的死亡事件，研究者应当向申办者和IRB/IEC提供所需要的全部附加资料（如解剖报告和最终医学报告）。
4.12 Premature Termination or Suspension of a Trial 试验中止或暂停
If the trial is prematurely terminated or suspended for any reason, the investigator/institution should promptly inform the trial subjects, should assure appropriate therapy and follow-up for the subjects, and, where required by the applicable regulatory requirement(s), should inform the regulatory authority(ies). In addition: 如果一个试验因为任何理由过早的停止或暂停，研究者/研究机构应当迅速通知试验对象，应当保证对象的合适治疗和随访，和根据适用的管理要求应当通知管理当局。另外：
4.12.1If the investigator terminates or suspends a trial without prior agreement of the sponsor, the investigator
should inform the institution where applicable, and the investigator/institution should promptly inform the sponsor and the IRB/IEC, and should provide the sponsor and the IRB/IEC a detailed written explanation of the termination or suspension.
如果研究者未与申办者事先协议便中止或暂停一个试验，研究者应当通知研究机构，研究者/研究机构应当立即通知申办者和IRB/IEC提供中止或暂停试验的详细书面解释。
4.12.2If the sponsor terminates or suspends a trial (see 5.21), the investigator should promptly inform the
institution where applicable and the investigator/institution should promptly inform the IRB/IEC and provide the IRB/IEC a detailed written explanation of the termination or suspension.
如果申办者中止或暂停一个试验（见5.21），研究者应当立即通知研究机构，研究者/研究机构应立即通知IRB/IEC并向IRB/IEC提供中止和暂停的详细书面解释。
4.12.3If the IRB/IEC terminates or suspends its approval/favourable opinion of a trial (see 3.1.2 and 3.3.9), the
investigator should inform the institution where applicable and the investigator/institution should promptly notify the sponsor and provide the sponsor with a detailed written explanation of the termination or suspension.
如果IRB/IEC终止或暂停它对一个试验的批准/赞成意见（见3.12和3.3.9），研究者应当通知研究机构，研究者/研究机构应当立即通报申办者并提供终止或暂停的详细书面解释。
4.13 Final Report(s) by Investigator 研究者的最终报告
Upon completion of the trial, the investigator, where applicable, should inform the institution; the investigator/institution should provide the IRB/IEC with a summary of the trial’s outcome, and the regulatory authority(ies) with any reports required.
在试验完成后，研究者应当通知研究机构，研究者/研究机构应当向IRB/IEC提供试验结果的摘要，向管理当局提供所需要的所有报告。
5. SPONSOR 申办者
5.1 Quality Assurance and Quality Control 质量保证和质量控制
5.1.1 The sponsor is responsible for implementing and maintaining quality assurance and quality control
systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s). 申办者负责按照书面ＳＯＰ执行和维持质量保证和质量控制系统，保证试验的实施和数据的产生、记录和报告询询试验方案、ＧＣＰ、及适用的管理要求。
5.1.2 The sponsor is responsible for securing agreement from all involved parties to ensure direct access (see
1.21) to all trial related sites, source data/documents , and reports for the purpose of monitoring and auditing by the sponsor, and inspection by domestic and foreign regulatory authorities. 申办者有责任保护各有关方面的协议，保证申办者以检查和稽查为目的的直接访问（见1.21）各有关试验单位、源数据/文件、报告，以及保证国内和国外管理当局的视察。
5.1.3 Quality control should be applied to each stage of data handling to ensure that all data are reliable and
have been processed correctly. 在数据处理的每一阶段都应当有质量控制，以保证所有的数据是可靠的并已经得到正确处理。 5.1.4 Agreements, made by the sponsor with the investigator/institution and any other parties involved with
the clinical trial, should be in writing, as part of the protocol or in a separate agreement. 申办者和研究者/研究机构以及参加临床试验的其他方应当订立书面协议；协议可以是方案的一部分，也可以上单独的协议。
5.2 Contract Research Organization (CRO) 合同研究组织
5.2.1 A sponsor may transfer any or all of the sponsor's trial-related duties and functions to a CRO, but the
ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement quality assurance and quality control.
申办者可以将与试验有关的责任和任务部分或全部转移给一个ＣＲＯ，但是试验数据的质量和完整性的最终责任永远在申办者。ＣＲＯ应当建立质量保证和质量控制。
5.2.2 Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in
writing.
转移给ＣＲＯ的或ＣＲＯ承担的任何与试验有关的责任和职能应当有书面说明。
5.2.3 Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained
by the sponsor.
没有明确转移给ＣＲＯ或由ＣＲＯ承担的任何与试验有关责任和职能仍然由申办者承担。
5.2.4 All references to a sponsor in this guideline also apply to a CRO to the extent that a CRO has assumed the
trial related duties and functions of a sponsor.
本指导原则中涉及申办者的一切也适用于一个ＣＲＯ，就像ＣＲＯ已经承担了一个申办者的与试验相关责任和职能。
5.3 Medical Expertise 医学专家
The sponsor should designate appropriately qualified medical personnel who will be readily available to advise on trial related medical questions or problems. If necessary, outside consultant(s) may be appointed for this purpose.
申办者应当指定有合适资格的医学人员，他们能迅速对试验有关疑问或问题提出建议。如果必要，可以人民外来顾问。
5.4 Trial Design 试验设计
5.4.1 The sponsor should utilize qualified individuals (e.g. biostatisticians, clinical harmacologists, and
physicians) as appropriate, throughout all stages of the trial process, from designing the protocol and CRFs and planning the analyses to analyzing and preparing interim and final clinical trial reports.
在试验过程的各个阶段，从设计试验方案、ＣＲＦ、计划分析到分析和准备中期与最终临床试验报告，申办者应当任用有合适资格的人（如生物统计学专家，临床药理学家和医生）。 5.4.2 For further guidance: Clinical Trial Protocol and Protocol Amendment(s) (see 6.), the ICH Guideline for Structure and Content of Clinical Study Reports, and other appropriate ICH guidance on trial design, protocol and conduct.
进一步的指导原则：《临床试验方案和方案修改》（见6.），《ＩＣＨ临床试验报告的结构 和内容指导原则》和关于试验设计、方案和执行的其他ＩＣＨ指导原则。
5.5 Trial Management, Data Handling, and Record Keeping
试验管理、数据处理与记录保存
5.5.1 The sponsor should utilize appropriately qualified individuals to supervise the overall conduct of the trial,
to handle the data, to verify the data, to conduct the statistical analyses, and to prepare the trial reports.
申办者应当任用有合适资格的人监督试验的全面实施、处理数据、核对数据，进行统计分析和准备试验报告。
5.5.2 The sponsor may consider establishing an independent data-monitoring committee (IDMC) to assess the
progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial. The IDMC should have written operating procedures and maintain written records of all its meetings.
申办者应考虑建立一个独立的数据监察委员会（ＩＤＭＣ），定期评价临床试验的 进展、修改或停
止试验。ＩＤＭＣ应当有书面的操作程序并保存它所有的会议记录。
5.5.3 When using electronic trial data handling and/or remote electronic trial data systems, the sponsor
should:
应用电子试验数据处理和/或遥控电子试验数据系统时，申办者应当：
a) Ensure and document that the electronic data processing system(s) conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistent intended performance (i.e. validation). 确保并证明电子数据处理系统符合申办者所设定的关于完整性、准确性、可靠性和一致期望的性能（如数据确认）的要求。
b) Maintains SOPs for using these systems. 保持使用这些系统的SOP
c) Ensure that the systems are designed to permit data changes in such a way that the data changes are documented and that there is no deletion of entered data (i.e. maintain an audit trail, data trail, edit trail). 保证系统的设计允许数据修改按如下方式进行：数据的改变被记录下来而不删除已经录入的数据（即保留稽查痕迹、数据痕迹和编辑痕迹）
d) Maintain a security system that prevents unauthorized access to the data. 有一个防止未经授权人员访问数据的安全体系
e) Maintain a list of the individuals who are authorized to make data changes (see 4.1.5 and 4.9.3). 有一份被授权修改数据的人员名单（见4.1.5和4.9.3） f) Maintain adequate backup of the data. 足够的数据备份
g) Safeguard the blinding, if any (e.g. maintain the blinding during data entry and processing). 如采用盲法，保护盲法安全（在数据输入和处理期间维持盲法）
5.5.4 If data are transformed during processing, it should always be possible to compare the original data and
observations with the processed data.
如果再处理中数据作了转换，将原始数据和观测值与处理后得数据进行比较。
5.5.5 The sponsor should use an unambiguous subject identification code (see 1.58) that allows identification
of all the data reported for each subject. 申办者应当使用明确得对象识别码（见1.58），以鉴别所报告得每一位对象得所有数据。 5.5.6 The sponsor, or other owners of the data, should retain all of the sponsor-specific essential documents
pertaining to the trial (see 8. Essential Documents for the Conduct of a Clinical Trial).
ICH-GCP中英文对照（完整） - 图文
