申办者在得到全部多需要文件（如IRB/IEC和管理当局的批准/赞成意见）之前不得向研究者/研究机构提供试验药物。

5.14.3 The sponsor should ensure that written procedures include instructions that the investigator/institution

should follow for the handling and storage of investigational product(s) for the trial and documentation thereof. The procedures should address adequate and safe receipt, handling, storage, dispensing, retrieval of unused product from subjects, and return of unused investigational product(s) to the sponsor (or alternative disposition if authorized by the sponsor and in compliance with the applicable regulatory requirement(s)).

申办者应当确保书面操作程序包含研究者/研究机构应当遵循的关于试验用药品的处理和储存的说明及其文件。程序应当说明适当和安全的接受、处理、储存、分发、从对象处取回未使用的药物以及将未使用的试验用药品返回给申办者（或经申办者授权并遵照适用管理要求销毁）。 5.14.4 The sponsor should:

申办者应当：

a) Ensure timely delivery of investigational product(s) to the investigator(s). 确保按时将试验用药品送达研究者

b) Maintain records that document shipment, receipt, disposition, return, and destruction of the investigational product(s) (see 8. Essential Documents for the Conduct of a Clinical Trial). 保存证明运输、接收、分发、收回和销毁试验用药品的记录（见8.实施临床试验的基本文件） c) Maintain a system for retrieving investigational products and documenting this retrieval (e.g. for deficient product recall, reclaim after trial completion, expired product reclaim). 有一个取回试验用药品和记录取回的规定（如有缺陷产品的收回，在试验结束后归还，过期药品归还）。 d) Maintain a system for the disposition of unused investigational product(s) and for the documentation of this disposition. 有一个处置未使用研究药品和记录这种处置的规定。

5.14.5 The sponsor should: 申办者应当

a) Take steps to ensure that the investigational product(s) are stable over the period of use.

采取步骤以保证试验药品在整个使用期内的稳定性。

b) Maintain sufficient quantities of the investigational product(s) used in the trials to reconfirm specifications, should this become necessary, and maintain records of batch sample analyses and characteristics. To the extent stability permits, samples should be retained either until the analyses of the trial data are complete or as required by the applicable regulatory requirement(s), whichever represents the longer retention period. 维持足够数量的用于试验中的试验用药品，以在万一有必要时再确认其规格，并保存批样分析和特性记录。只要产品稳定性许可，样品应当被保留到试验数据分析完成或适用管理要求的需要时间，取两者中较长的期限。

5.15 Record Access 记录访问

5.15.1 The sponsor should ensure that it is specified in the protocol or other written agreement that the

investigator(s)/institution(s) provide direct access to source data/documents for trial-related monitoring, audits, IRB/IEC review, and regulatory inspection.

申办者应当确保在方按中或其他书面协议中已经说明，研究者/研究机构应允许试验有关的监察员、稽查员、IRB/IEC审评和管理部门视察直接访问原始数据。

5.15.2 The sponsor should verify that each subject has consented, in writing, to direct access to his/her original

medical records for trial-related monitoring, audit, IRB/IEC review, and regulatory inspection.

申办者应当核实，每一例对象已经书面同意，在进行鱼试验相关的检查、稽查、IRB/IEC审评和管理部门视察时直接访问他/她的原始医学记录

5.16 Safety Information 安全性资料

5.16.1 The sponsor is responsible for the ongoing safety evaluation of the investigational product(s).

申办者负责试验用药品正在进行的安全性评价。

5.16.2 The sponsor should promptly notify all concerned investigator(s)/institution(s) and the regulatory

authority(ies) of findings that could affect adversely the safety of subjects, impact the conduct of the trial, or alter the IRB/IEC's approval/favourable opinion to continue the trial.

申办者应当立即通知所有有关研究者/研究机构和管理当局关于可能对对象的安全性有不良影响、 影响试验实施的或改变IRB/IEC对继续试验的批准/赞成的发现。

5.17 Adverse Drug Reaction Reporting 药品不良反应报告

5.17.1 The sponsor should expedite the reporting to all concerned investigator(s)/institutions(s), to the

IRB(s)/IEC(s), where required, and to the regulatory authority(ies) of all adverse drug reactions (ADRs) that are both serious and unexpected.

申办者应当迅速向所有有关研究者/研究机构、有关的IRB/IEC、管理当局报告所有严重的和非预期的药品不良反应。

5.17.2 Such expedited reports should comply with the applicable regulatory requirement(s) and with the ICH

Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting.

这种快速报告应当符合适用管理要求和《ＩＣＨ临床安全性数据管理指导原则：快速报告的定义和标准》

5.17.3 The sponsor should submit to the regulatory authority(ies) all safety updates and periodic reports, as

required by applicable regulatory requirement(s).

申办者应当根据使用管理要求向管理当局提交全部安全性更新和定期报告。

5.18 Monitoring 监查

5.18.1 Purpose 目的

The purposes of trial monitoring are to verify that:

试验监查的目的是核实

a) The rights and well-being of human subjects are protected. 对象的权利和健康得到保护

b) The reported trial data are accurate, complete, and verifiable from source documents. 所报告的试验数据是准确和完整的，并能从原始文件得到证实。

c) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s). 试验的实施符合最近批准的方按/方按修改，符合ＧＣＰ和适用管理要求

5.18.2 Selection and Qualifications of Monitors

选择合格的监查员

a) Monitors should be appointed by the sponsor. 监察员应当由申办者指定

b) Monitors should be appropriately trained, and should have the scientific and/or clinical knowledge needed to monitor the trial adequately. A monitor’s qualifications should be documented. 监察员应当受过核实的培训，应当有足够的监察试验的科学/活临床知识。监察员的资格应当有文件证明。

c) Monitors should be thoroughly familiar with the investigational product(s), the protocol, written informed consent form and any other written information to be provided to subjects, the sponsor’s SOPs, GCP, and the applicable regulatory requirement(s). 监察员应当透彻了解试验用药品、研究方按、知情同意书和其他提供给对象的书面资料、申办者的各种ＳＯＰ、ＧＣＰ和适用管理要求。

5.18.3 Extent and Nature of Monitoring 监查的范围和性质

The sponsor should ensure that the trials are adequately monitored. The sponsor should determine the appropriate extent and nature of monitoring. The determination of the xtent and nature of monitoring should be based on considerations such as the objective, purpose, design, complexity, blinding, size, and endpoints of the trial. In general there is a need for on-site monitoring, before, during, and after the trial; however in exceptional circumstances the sponsor may determine that central monitoring in conjunction with procedures such as investigators’ training and meetings, and extensive written guidance can assure appropriate conduct of the trial in accordance with GCP. Statistically controlled sampling may be an acceptable method for selecting the data to be verified.

申办者应当保证试验得到适当的监察。申办者应当决定监察的合适范围和性质。监察的范围和性质应当根据目标、目的、设计、复杂性、盲法、样本大小和试验终点确定。通常需要在试验前、试验期间和试验后进行现场监察，但是在特别的场合，申办者可以决定与某些步骤，如研究人员培训和研究人员会议，合在一起的终点监察。多方面的书面指导原则可以保证恰当地按照ＧＣＰ实施试验。统计学上控制地抽样可能是一个可以接受地选择需要核对的数据的方法。 5.18.4 Monitor's Responsibilities 监查员的责任

The monitor(s) in accordance with the sponsor’s requirements should ensure that the trial is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and the trial site:

按照申办者的要求，在对试验和试验单位恰当和必要时，监察员应当通过下列活动保证试验被正确的实施和记录：

a) Acting as the main line of communication between the sponsor and the investigator. 在申办者和研究者之间的交流起干线作用。

b) Verifying that the investigator has adequate qualifications and resources (see 4.1, 4.2, 5.6) and remain adequate throughout the trial period, that facilities, including laboratories, equipment, and staff, are adequate to safely and properly conduct the trial and remain adequate throughout the trial period. 验证研究者有足够的资格和自愿（见4.1，4.2，5.6），并且在整个试验期间仍然是足够的；设备，包括实验室、仪器和职员足以安全和正确地实施试验，并在整个试验期间也是足够地。 c) Verifying, for the investigational product(s): 对于试验用药品，核实：

i) That storage times and conditions are acceptable, and that supplies are sufficient throughout the trial. 储存时间和条件是可以接受的，在整个试验中供应充足

ii) That the investigational product(s) are supplied only to subjects who are eligible to receive it and at the protocol specified dose(s). 试验用药品只按试验方案规定地剂量提供给合格地对象

iii) That subjects are provided with necessary instruction on properly using, handling, storing, and returning the investigational product(s). 向对象提供正确使用、处理、储存和归还试验用药品地说明

iv) That the receipt, use, and return of the investigational product(s) at the trial sites are controlled and documented adequately. 在试验单位，试验用药品接收、使用和归还试验用药品地说明

v) That the disposition of unused investigational product(s) at the trial sites complies with applicable regulatory requirement(s) and is in accordance with the sponsor.