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概念:研究者 [2022/02/25 04:10]
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概念:研究者 [2022/02/28 09:08] (当前版本)
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| {{ :概念:pi.jpeg?nolink&500|}} | **研究者**：指实施临床试验并对临床试验质量及受试者权益和安全负责的试验现场的负责人。(([[法规:药物临床试验质量管理规范#第二章_术语及其定义|药物临床试验质量管理规范（GCP）]]. [[概念:国家药品监督管理局]]. 2020)) |
| <font inherit/inherit;;#2980b9;;inherit>**研究者：**</font>指实施临床试验并对临床试验质量及受试者权益和安全负责的试验现场的负责人。(([[法规:药物临床试验质量管理规范|]]. 2020年第57号)) \\ | |
| <font inherit/inherit;;#2980b9;;inherit>**Investigator：**</font>A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. See also Subinvestigator.(([[法规:ich-gcp|ICH-GCP]]. E6(R2), 2016)) | |
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| | **Investigator**：A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. See also Subinvestigator.(([[法规:ich-gcp|ICH GCP (E6(R2))]]. [[概念:ICH]]. 2016)) |
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| <font inherit/inherit;;#2980b9;;inherit>**主要研究者：**</font>临床试验中某一研究中心的负责人。GCP里提到的研究者即指的是主要研究者。广义的研究者也包含次要研究者。\\ | **主要研究者**：临床试验中某一研究中心的负责人。GCP里提到的研究者即指的是主要研究者。广义的研究者也包含次要研究者。 |
| <font inherit/inherit;;#2980b9;;inherit>**Principal Investigator (PI)**</font>is the physician who leads the conduct of a clinical trial at a study site. (([[https://www.amgen.com/science/clinical-trials/information-for-healthcare-professionals/investigator-resources/|How to Become a Principal Investigator]]. www.amgen.com)) | |
| | **Principal Investigator (PI)**：is the physician who leads the conduct of a clinical trial at a study site. (([[https://www.amgen.com/science/clinical-trials/information-for-healthcare-professionals/investigator-resources/|How to Become a Principal Investigator]]. www.amgen.com)) |
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| <font inherit/inherit;;#2980b9;;inherit>**次要研究者：**</font>在一个试验单位，在主要研究者指定和监督下的临床试验组中完成与试验有关的重要程序和/或作出与有关试验的重大决定的成员(如同事，住院医生，特别是研究生)；通常是具有执业资格的研究医生。\\ | **次要研究者**：在一个试验单位，在主要研究者指定和监督下的临床试验组中完成与试验有关的重要程序和/或作出与有关试验的重大决定的成员(如同事，住院医生，特别是研究生)；通常是具有执业资格的研究医生。 |
| <font inherit/inherit;;#2980b9;;inherit>**Sub Investigator (Sub-I)**</font> is any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows).(([[法规:ich-gcp|ICH-GCP]]. E6(R2), 2016)) | |
| | **Sub Investigator (Sub-I)**：is any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows).(([[法规:ich-gcp|ICH GCP (E6(R2))]]. [[概念:ICH]]. 2016)) |
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| <font inherit/inherit;;#2980b9;;inherit>**协调研究者：**</font>在多中心临床试验中负责协调参加各中心研究者工作的一名研究者。\\ | **协调研究者**：在多中心临床试验中负责协调参加各中心研究者工作的一名研究者。 |
| <font inherit/inherit;;#2980b9;;inherit>**Coordinating Investigator (Co-Investigator)**</font> is an investigator assigned the responsibility for the coordination of investigators at different centres participating in a multicentre trial.(([[法规:ich-gcp|ICH-GCP]]. E6(R2), 2016)) | |
| | **Coordinating Investigator (Co-Investigator)**：is an investigator assigned the responsibility for the coordination of investigators at different centres participating in a multicentre trial.(([[法规:ich-gcp|ICH-GCP]]. E6(R2), 2016)) |
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| <font inherit/inherit;;#2980b9;;inherit>**牵头研究者（Leading PI）：**</font>在多中心临床试验中，负责整个临床试验的研究者。常为牵头单位/组长单位的主要研究者。 | **牵头研究者（Leading PI）**：在多中心临床试验中，负责整个临床试验的研究者。常为牵头单位/组长单位的主要研究者。 |
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| <font inherit/inherit;;#2980b9;;inherit>**申办者-研究者：**</font>单独或与其他人一起，发起并实施一个临床试验的个人。在他(们)的直接指示下，给对象服用、发给对象或由对象使用试验用药品。该术语并不包括除了个人以外的任何组织(即不是一个公司或者机构)。一个申办者-研究者的义务包括一个申办者和一个研究者两者的义务。\\ | **申办者-研究者**：单独或与其他人一起，发起并实施一个临床试验的个人。在他(们)的直接指示下，给对象服用、发给对象或由对象使用试验用药品。该术语并不包括除了个人以外的任何组织(即不是一个公司或者机构)。一个申办者-研究者的义务包括一个申办者和一个研究者两者的义务。 |
| <font inherit/inherit;;#2980b9;;inherit>**Sponsor-Investigator**</font> is an individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.(([[法规:ich-gcp|ICH-GCP]]. E6(R2), 2016)) | |
| | **Sponsor-Investigator**：is an individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.(([[法规:ich-gcp|ICH GCP (E6(R2))]]. [[概念:ICH]]. 2016)) |
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| ===== 二、要 求 ===== | ===== 一、要 求 ===== |
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| - 具有在临床试验机构的执业资格。 | - 具有在临床试验机构的执业资格。 |
| - 研究者在临床试验约定的期限内有足够的时间实施和完成临床试验。 | - 研究者在临床试验约定的期限内有足够的时间实施和完成临床试验。 |
| - 研究者在临床试验期间有权支配参与临床试验的人员，具有使用临床试验所需医疗设施的权限，正确、安全地实施临床试验。 | - 研究者在临床试验期间有权支配参与临床试验的人员，具有使用临床试验所需医疗设施的权限，正确、安全地实施临床试验。 |
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