发布时间 : 星期一 文章ICH-GCP中英文对照（完整） - 图文更新完毕开始阅读0d3ed718cd7931b765ce0508763231126edb7701
试验单位对未使用地试验用药品地处置符合管理要求和申办者地要求。
d) Verifying that the investigator follows the approved protocol and all approved amendment(s), if any. 核实研究者遵循已批准地方案和所有已批准的修改
e) Verifying that written informed consent was obtained before each subject's participation in the trial. 核实在每个研究对象参加试验前已经得到书面的知情同意
f) Ensuring that the investigator receives the current Investigator's Brochure, all documents, and all trial supplies needed to conduct the trial properly and to comply with the applicable regulatory requirement(s). 确保研究者收到最近的研究者手册、所有的文件和按照适用管理要求正确实施试验必需的所有试验用品。
g) Ensuring that the investigator and the investigator's trial staff are adequately informed about the trial. 保证研究者及其试验职员对试验有充分的知识
h) Verifying that the investigator and the investigator's trial staff are performing the specified trial functions, in accordance with the protocol and any other written agreement between the sponsor and the investigator/institution, and have not delegated these functions to unauthorized individuals. 核实研究者及其试验职员正在按照方案和申办者与研究者/研究机构之间的其他书面协议执行特定的试验职责，没有将这些职责委派给未经授权的人。 i) Verifying that the investigator is enrolling only eligible subjects. 核实研究者只招募合格的对象 j) Reporting the subject recruitment rate. 报告对象招募速度
k) Verifying that source documents and other trial records are accurate, complete, kept up-to-date and maintained. 核实源文件和其他试验记录是准确的、完整的、保持更新并都保存着
l) Verifying that the investigator provides all the required reports, notifications, applications, and submissions, and that these documents are accurate, complete, timely, legible, dated, and identify the trial. 确保研究者提供所有需要的报告、通知、申请和递交的文件，并且这些文件都是准确、完整、按时、清晰易读、注明日期和试验鉴别
m) Checking the accuracy and completeness of the CRF entries, source documents and other trial-related records against each other. The monitor specifically should verify that: 彼此对照检查ＣＲＦ记录、源文件和其他试验有感记录的准确系国内和完整性。监察员尤其应当检查：
i) The data required by the protocol are reported accurately on the CRFs and are consistent with the
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。