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概念:不良事件 [2022/03/04 04:03]
老T [一、不良事件] |
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 ====== |
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| ^序号^评定^说明^ | ^序号^评定^说明^ |
| |1|Certain|a clinical event, including laboratory test abnormality, occurring in a plausible time relationship to drug administration, and which cannot be explained by concurrent disease or other drugs or chemicals. The response to withdrawal of the drug (dechallenge) should be clinically plausible. The event must be definitive pharmacologically or phenomenologically, using a satisfactory rechallenge procedure if necessary.| | |1|**Certain**|a clinical event, including laboratory test abnormality, occurring in a plausible time relationship to drug administration, and which cannot be explained by concurrent disease or other drugs or chemicals. The response to withdrawal of the drug (dechallenge) should be clinically plausible. The event must be definitive pharmacologically or phenomenologically, using a satisfactory rechallenge procedure if necessary.| |
| |2|Probable/Likely|a clinical event, including laboratory test abnormality, with a reasonable time sequence to administration of the drug, unlikely to be attributed to concurrent disease or other drugs or chemicals, and which follows a clinically reasonable response on withdrawal (dechallenge). Rechallenge information is not required to fulfil this definition. | | |2|**Probable/Likely**|a clinical event, including laboratory test abnormality, with a reasonable time sequence to administration of the drug, unlikely to be attributed to concurrent disease or other drugs or chemicals, and which follows a clinically reasonable response on withdrawal (dechallenge). Rechallenge information is not required to fulfil this definition.| |
| | |3|**Possible**|a clinical event, including laboratory test abnormality, with a reasonable time sequence to administrations of the drug, but which could also be explained by concurrent disease or other drugs or chemicals. Information on drug withdrawal may be lacking or unclear.| |
| | |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.| |
| | |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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