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概念:不良事件 [2022/02/23 04:09] 老T |
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) |
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- | ====== 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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====== 一、不良事件 ====== | ====== 一、不良事件 ====== | ||
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{{ : | {{ : | ||
- | **不良事件:** 指受试者接受试验用药品后出现的所有不良医学事件,可以表现为症状体征、疾病或者实验室检查异常,但不一定与试验用药品有因果关系。(([[法规: | + | **不良事件:** 指受试者接受试验用药品后出现的所有不良医学事件,可以表现为症状体征、疾病或者实验室检查异常,但不一定与试验用药品有因果关系。(([[法规: |
- | **Adverse Event (AE):** Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.(([[法规: | + | **Adverse Event (AE):** Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.(([[法规: |
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+ | ===== 不良事件相关性 ===== | ||
+ | 1. WHO 乌普萨拉中心国际药品ADR监测合作中心 | ||
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+ | ^序号^评定^说明^ | ||
+ | |1|**Certain**|a clinical event, including laboratory test abnormality, | ||
+ | |2|**Probable/ | ||
+ | |3|**Possible**|a clinical event, including laboratory test abnormality, | ||
+ | |4|**Unlikely**|a clinical event, including laboratory test abnormality, | ||
+ | |5|**Conditional/ | ||
+ | |6|**Unassessable/ | ||
===== 二、严重不良事件 ===== | ===== 二、严重不良事件 ===== | ||
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{{ : | {{ : | ||
- | **严重不良事件:** 指受试者接受试验用药品后出现死亡、危及生命、永久或者严重的残疾或者功能丧失、受试者需要住院治疗或者延长住院时间,以及先天性异常或者出生缺陷等不良医学事件。(([[法规: | + | **严重不良事件:** 指受试者接受试验用药品后出现死亡、危及生命、永久或者严重的残疾或者功能丧失、受试者需要住院治疗或者延长住院时间,以及先天性异常或者出生缺陷等不良医学事件。(([[法规: |
- | **Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR):**Any untoward medical occurrence that at any dose: | + | **Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR):**Any untoward medical occurrence that at any dose: |
- results in death | - results in death | ||
- is life-threatening | - is life-threatening | ||
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===== 四、扩展阅读 ===== | ===== 四、扩展阅读 ===== | ||
- | * [[http:// | + | * [[http:// |
- | * | + | * [[参考: |
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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: |
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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