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两侧同时换到之前的修订记录 前一修订版 后一修订版 | 前一修订版 | ||
概念:研究者 [2022/02/28 09:00] 老T |
概念:研究者 [2022/02/28 09:08] (当前版本) 老T |
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**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: | **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: | ||
- | **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: | + | {{ : |
+ | **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: | ||
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- | 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。 | + | **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。 |
**Principal Investigator (PI)**:is the physician who leads the conduct of a clinical trial at a study site. (([[https:// | **Principal Investigator (PI)**:is the physician who leads the conduct of a clinical trial at a study site. (([[https:// | ||
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- | <font inherit/ | + | **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。 |
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+ | **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: | ||
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