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概念:不良事件 [2022/03/04 04:07]
老T [不良事件相关性] |
概念:不良事件 [2023/11/16 09:54] (当前版本)
老T 已恢复为旧版 (2023/08/29 07:09) |
| ====== 不良事件 AE / 严重不良事件 SAE ====== | ====== 不良事件 AE / 严重不良事件 SAE ====== |
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| | <font inherit/inherit;;inherit;;#FFFF00>（[[:系统:待完成?do=backlink|由于新版GCP和GVP的发布，AE和SAE的汇报、管理需要更新]]）</font> |
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| ====== 一、不良事件 ====== | ====== 一、不良事件 ====== |
| |4|**Unlikely**|a clinical event, including laboratory test abnormality, with a temporal relationship to drug administration which makes a causal relationship improbable, and in which other drugs, chemicals or underlying disease provide plausible explanations.| | |4|**Unlikely**|a clinical event, including laboratory test abnormality, with a temporal relationship to drug administration which makes a causal relationship improbable, and in which other drugs, chemicals or underlying disease provide plausible explanations.| |
| |5|**Conditional/Unclassified**|a clinical event, including laboratory test abnormality, reported as an adverse reaction, about which more data is essential for a proper assessment, or the additional data is under examination.| | |5|**Conditional/Unclassified**|a clinical event, including laboratory test abnormality, reported as an adverse reaction, about which more data is essential for a proper assessment, or the additional data is under examination.| |
| |6|**Unassessable/Unclassifiable**|a report suggesting an adverse reaction which cannot be judged because information is insufficient or contradictory, and which cannot be supplemented or verified. | | |6|**Unassessable/Unclassifiable**|a report suggesting an adverse reaction which cannot be judged because information is insufficient or contradictory, and which cannot be supplemented or verified.| |
| ===== 二、严重不良事件 ===== | ===== 二、严重不良事件 ===== |
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| ===== 四、扩展阅读 ===== | ===== 四、扩展阅读 ===== |
| * [[http://www.doc88.com/p-7028340106204.html|《药品不良反应知识100问》]]，国家药品不良反应监测中心，2011(([[http://www.cdr-adr.org.cn/xwdt/200412/t20041227_3545.html|"药品不良反应知识100问"出版]]. 2011)) | * [[http://www.doc88.com/p-7028340106204.html|《药品不良反应知识100问》]]. 国家药品不良反应监测中心. 2011(([[http://www.cdr-adr.org.cn/xwdt/200412/t20041227_3545.html|"药品不良反应知识100问"出版]]. 2011)) |
| * | * [[参考:药物临床试验不良事件关联性判定方法研究探讨|药物临床试验不良反应/不良事件关联性判定方法研究探讨]]. 李博，高蕊，李睿等. 中国新药杂志, 2014年, 第23卷第12期 |
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| 1. 提问：化验单中的异常值什么情况下判定为有临床意义？什么情况下的异常值需要报AE？\\ | 1. 提问：化验单中的异常值什么情况下判定为有临床意义？什么情况下的异常值需要报AE？\\ |
| 回答： | 回答： |
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| 2. 提问：\\ | 2. 提问：\\ |
| 回答： | 回答： |
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| | SAEA的上报流程要更新下了吧，根据2020新版GCP，大部分SAE已经不需要24小时上报了 |
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