申办者或数据得其他拥有者应当保留申办者当得有关试验得所有基本文件（见8.实施临床试验得基本文件）。 5.5.7 The sponsor should retain all sponsor-specific essential documents in conformance with the applicable regulatory requirement(s) of the country(ies) where the product is approved, and/or where the sponsor intends to apply for approval(s).
申办者应当保留所有申办者方的、与产品被批准和/或申办者打算申请批准的国家适用管理要求一致的基本文件。
5.5.8 If the sponsor discontinues the clinical development of an investigational product (i.e. for any or all
indications, routes of administration, or dosage forms), the sponsor should maintain all sponsor-specific essential documents for at least 2 years after formal discontinuation or in conformance with the applicable regulatory requirement(s).
如果申办者停止一个试验用药品的临床研究（如某个或所有适应证，给药途径，或剂型），申办者应当保留所有申办者方的基本文件至正式停止后至少2年，或与适用管理规定一致。
5.5.9 If the sponsor discontinues the clinical development of an investigational product, the sponsor should
notify all the trial investigators/institutions and all the regulatory authorities.
如果申办者停止一个试验用药品的临床研究，申办者应当通报所有研究者/研究机构和所有管理部门。
5.5.10 Any transfer of ownership of the data should be reported to the appropriate authority(ies), as required
by the applicable regulatory requirement(s).
任何数据所有权的转让应依照现行管理法规的要求想所属的管理当局报告
5.5.11 The sponsor specific 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 requirement(s) or if needed by the sponsor.
申办者方的基本文件应当被保留到最后批准在一个ＩＣＨ地区上市应用后至少2年，和直至在一个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已过去至少2年。但如果适用管理要求需要或申办者要求，这些文件应当被保留更长时间。
5.5.12 The sponsor should inform the investigator(s)/institution(s) in writing of the need for record retention
and should notify the investigator(s)/institution(s) in writing when the trial related records are no longer needed.
申办者应当以书面通知研究者/研究机构关于记录保存得要求，当试验相关记录不再需要时应书面通报研究者/研究机构。
5.6 Investigator Selection 研究者选择
5.6.1 The sponsor is responsible for selecting the investigator(s)/institution(s). Each investigator should be
qualified by training and experience and should have adequate resources (see 4.1, 4.2) to properly
conduct the trial for which the investigator is selected. If organization of a coordinating committee and/or selection of coordinating investigator(s) are to be utilized in multicentre trials, their organization and/or selection are the sponsor's responsibility.
申办者有责任选择研究者/研究机构。每一个研究者应当时通过培训合格的和有经验的，应当有足够的自愿（见4.1，4.2）正确的实施其被选择来进行的试验。如果在多中心试验中将组织一个协调委员会组织和/或选择协调研究者，他们的组织和/或选择是申办者的责任。
5.6.2 Before entering an agreement with an investigator/institution to conduct a trial, the sponsor should
provide the investigator(s)/institution(s) with the protocol and an up-to-date Investigator's Brochure, and should provide sufficient time for the investigator/institution to review the protocol and the information provided.
在与研究者/研究机构签署一个进行试验的协议之前，申办者应当向研究者/研究机构提供试验方按和最新的研究者手册，并应当提供足够的时间让研究者/研究机构去审议方按和所提供的资料。 5.6.3 The sponsor should obtain the investigator's/institution's agreement:
申办者应获得研究者或研究机构的同意
a) to conduct the trial in compliance with GCP, with the applicable regulatory requirement(s) (see 4.1.3), and with the protocol agreed to by the sponsor and given pproval/favourable opinion by the IRB/IEC (see 4.5.1); 按照ＧＣＰ、适用管理要求（见4.1.3）和经申办者同意、IRB/IEC批准/赞成（见4.5.1）和方按实施临床试验。
b) to comply with procedures for data recording/reporting; 遵循数据记录/报告程序
c) to permit monitoring, auditing and inspection (see 4.1.4) and 运行监查、稽查及视察
d) to retain the trial related essential documents until the sponsor informs the investigator/ institution these documents are no longer needed (see 4.9.4 and 5.5.12). 允许保留与试验有关的基本文件直至申办者通知研究者/研究机构这些文件不再需要为止（见4.9.4和5.5.12）
The sponsor and the investigator/institution should sign the protocol, or an alternative document, to confirm this agreement.
在开始一个试验前，申办者应当定义、规定和分配与试验相关的责任和职能。
5.7 Allocation of Responsibilities 职责的分配
Prior to initiating a trial, the sponsor should define, establish, and allocate all trial-related duties and functions. 在开始一个试验前，申办者应当定义、规定和分配与试验相关的责任和职能。
5.8 Compensation to Subjects and Investigators 对受试者、研究者的补偿
5.8.1 If required by the applicable regulatory requirement(s), the sponsor should provide insurance or should
indemnify (legal and financial coverage) the investigator/the institution against claims arising from the trial, except for claims that arise from malpractice and/or negligence.
如果适用管理要求需要，申办者应当提供保险或应当补偿（法律和财政的范围）研究者/研究机构因试验而提出的要求，但因治疗不当和/或过失所致的除外。
5.8.2 The sponsor's policies and procedures should address the costs of treatment of trial subjects in the event
of trial-related injuries in accordance with the applicable regulatory requirement(s).
申办者的保险单和程序应当说明符合适用管理要求的与试验相关的伤害事件中试验对象治疗的费用。
5.8.3 When trial subjects receive compensation, the method and manner of compensation should comply with
applicable regulatory requirement(s).
试验对象收到补偿时，补偿的方法和方式应当符合适用管理要求。
5.9 Financing 财务
The financial aspects of the trial should be documented in an agreement between the sponsor and the investigator/institution.
试验的财务方面内容应当列入申办者和研究者/研究机构之间的协议中。
5.10 Notification/Submission to Regulatory Authority(ies) 向管理当局通知或申报
Before initiating the clinical trial(s), the sponsor (or the sponsor and the investigator, if required by the applicable regulatory requirement(s)) should submit any required application(s) to the appropriate authority(ies) for review, acceptance, and/or permission (as required by the applicable regulatory requirement(s)) to begin the trial(s). Any notification/submission should be dated and contain sufficient information to identify the protocol.
在开始临床试验前，申办者（或适用管理要求需要，申办者和研究者）应当向相应的管理部门提交所需要的申请表，供审评、接受和/或许可（如适用管理要求需要）开始试验。通报/提交的资料应当注明日期，并包括足够鉴定试验方按的资料。
5.11 Confirmation of Review by IRB/IEC IRB/IEC的评审和确认
5.11.1 The sponsor should obtain from the investigator/institution:
申办者应当从研究者/研究机构方得到：
a) The name and address of the investigator's/institution’s IRB/IEC. 研究者/研究机构方的IRB/IEC成员的姓名和地址
b) A statement obtained from the IRB/IEC that it is organized and operates according to GCP and the applicable laws and regulations. IRB/IEC关于其组织和操作符合ＧＣＰ和适用法律法规的陈述
c) Documented IRB/IEC approval/favourable opinion and, if requested by the sponsor, a current copy of protocol, written informed consent form(s) and any other written information to be provided to subjects, subject recruiting procedures, and documents related to payments and compensation available to the subjects, and any other documents that the IRB/IEC may have requested. 书面的IRB/IEC批准/赞成；如果申办者要求，最新的试验方按、书面知情同意书和其他将提供给对象书面资料的复印件，对象接纳程序，和给予对象的支付和补偿的有关文件，以及IRB/IEC所要的其他文件。
5.11.2 If the IRB/IEC conditions its approval/favourable opinion upon change(s) in any aspect of the trial, such
as modification(s) of the protocol, written informed consent form and any other written information to be provided to subjects, and/or other procedures, the sponsor should obtain from the investigator/institution a copy of the modification(s) made and the date approval/favourable opinion was given by the IRB/IEC.
如果IRB/IEC以修改试验的某个方面作为批准/赞成的条件，如修改方按，书面的知情同意书和其他提供给对象和/或其他程序的书面资料，申办者应当从研究者/研究机构得到已作出修改的副本和IRB/IEC给出批准/赞成日期。
5.11.3 The sponsor should obtain from the investigator/institution documentation and dates of any IRB/IEC
reapprovals/re-evaluations with favourable opinion, and of any withdrawals or suspensions of approval/favourable opinion.
申办者应当从研究者/研究机构得到所有IRB/IEC给出赞成意见的再批准/再评价，以及撤销或暂停批准/赞成的文件和日期。
5.12 Information on Investigational Product(s) 有关试验药品的信息
5.12.1 When planning trials, the sponsor should ensure that sufficient safety and efficacy data from nonclinical
studies and/or clinical trials are available to support human exposure by the route, at the dosages, for the duration, and in the trial population to be studied.
计划试验时，申办者应当保证有足够的非临床研究和/或临床研究的安全性和有效性数据支持所研究的试验人群暴露的给药途径、剂量和持续时间。
5.12.2 The sponsor should update the Investigator's Brochure as significant new information becomes
available (see 7. Investigator's Brochure).
当有重要的新资料时，申办者应当更新研究者手册（见7.研究者手册）。
5.13 Manufacturing, Packaging, Labelling, and Coding Investigational Product(s)
试验药品生产、包装、标签和编码
5.13.1 The sponsor should ensure that the investigational product(s) (including active comparator(s) and
placebo, if applicable) is characterized as appropriate to the stage of development of the product(s), is manufactured in accordance with any applicable GMP, and is coded and labelled in a manner that protects the blinding, if applicable. In addition, the labelling should comply with applicable regulatory requirement(s).
申办者应当保证试验用药品（包括活性对照品和安慰剂）具有适合产品开发阶段的特性，按照适用的ＧＭＰ生产、编码和标签的方式应适合于保护盲法。此外，标签应当符合适用管理要求。 5.13.2 The sponsor should determine, for the investigational product(s), acceptable storage temperatures,
storage conditions (e.g. protection from light), storage times, reconstitution fluids and procedures, and devices for product infusion, if any. The sponsor should inform all involved parties (e.g. monitors, investigators, pharmacists, storage managers) of these determinations.
申办者应当确定试验用药品的允许储存温度、储存条件（如避光）、储存时间、重组溶液和程序，以及必要时药物的输注装置。申办者应当将这些决定通知所有有关各方（如监察员、研究者、药师、储存管理人员）。 5.13.3 The investigational product(s) should be packaged to prevent contamination and unacceptable deterioration during transport and storage.
试验用药品的包装应当能防止在运输和储存期间受污染和不可接受的变质。
5.13.4 In blinded trials, the coding system for the investigational product(s) should include a mechanism that
permits rapid identification of the product(s) in case of a medical emergency, but does not permit undetectable breaks of the blinding.
在盲法试验中，试验用药品的编码系统应当包括一种在医学紧急情况下允许迅速鉴别药品、但不允许不可监测的破盲机制。
5.13.5 If significant formulation changes are made in the investigational or comparator product(s) during the
course of clinical development, the results of any additional studies of the formulated product(s) (e.g. stability, dissolution rate, bioavailability) needed to assess whether these changes would significantly alter the pharmacokinetic profile of the product should be available prior to the use of the new formulation in clinical trials.
在临床研究其间如果试验用药品或对照产品的配方有明显改变，应当在新制剂用于临床试验之前获得制剂产品的附加研究结果（如稳定性、溶出速率，生物利用度），以评价这些改变是否明显改变产品药代动力学特征。
5.14 Supplying and Handling Investigational Product(s) 试验药品的供应和管理
5.14.1 The sponsor is responsible for supplying the investigator(s)/institution(s) with the investigational
product(s).
申办者负责向研究者/研究机构提供试验用药品
5.14.2 The sponsor should not supply an investigator/institution with the investigational product(s) until the
sponsor obtains all required documentation (e.g. approval/favourable opinion from IRB/IEC and regulatory authority(ies)).
ICH-GCP中英文对照（完整） - 图文
