4. INVESTIGATOR 研究者
4.1 Investigator's Qualifications and Agreements
研究者的资格和协议
4.1.1 The investigator(s) should be qualified by education, training, and
experience to assume responsibility for the proper conduct of the trial, should
meet all the qualifications specified by the applicable regulatory
requirement(s), and should provide evidence of such qualifications through
up-to-date curriculum vitae and/or other relevant documentation requested by the
sponsor, the IRB/IEC, and/or the regulatory authority(ies).
研究者应当在受教育、培训和经验方面有资格承担实施试验的责任，应当符合适用的管理要求所说明的所有条件，并应当通过最新的个人简历/或申办者、IRB/IEC和/或管理当局要求的其他相关文件提供这种资格证明。
4.1.2 The investigator should be thoroughly familiar with the appropriate use
of the investigational product(s), as described in the protocol, in the current
Investigator's Brochure, in the product information and in other information
sources provided by the sponsor.
研究者应当充分熟悉在试验方案、研究者手册、产品自料以及申办者提供的其他资料中所述的试验用药品的合适用途。
4.1.3 The investigator should be aware of, and should comply with, GCP and
the applicable regulatory requirements.
研究者应当了解并遵循GCP和适用的管理要求。
4.1.4 The investigator/institution should permit monitoring and auditing by
the sponsor, and inspection by the appropriate regulatory authority(ies).
研究者/研究机构应当允许申办者的监查和稽查，以及管理部门的视察。
4.1.5 The investigator should maintain a list of appropriately qualified
persons to whom the investigator has delegated significant trial-related
duties.
研究者应当有一份合适资格、并已委派给他们与试验相关的和总要任务的人员名单。
