AE_and_SAE不良反应以及严重不良反应.ppt

* The issue of code breaks is often raised in relation to the discovery of Serious Adverse Events. Keep in mind that: Code breaks should occur ONLY when the identity of the trial treatment is essential for the management of a medical emergency, or in the event of a pregnancy. The need to perform code breaks is a rare occurrence. To be prepared for this rare situation, know the exact location of physical codes, or the trial-specific requirements surrounding code breaking through Interactive Voice Response System. An example: A patient takes his study medication and stops breathing; the site needs to know what the patient was randomized to on study in order to better treat and evaluate this event. * If a code must be broken, it must be authorized by a medical doctor on your staff and result in withdrawal of the subject from the trial. Make sure you discuss this situation with your Site Manager before breaking the code and inform him/her about the outcome of a code break as soon as possible. Document in the Trial Center File and in the source documents that the code was broken including the date, name(s) of the person(s) authorizing the code break as well as the method and reason for the break. Excel PharmaStudies Inc. Excel PharmaStudies Inc. 30 Oct. 2006 Excel PharmaStudies Inc. * 不良事件和严重不良事件 内部培训 徐雅 30 Oct. 2006 Excel PharmaStudies Inc. * 主要内容 定义和报告程序 药品不良事件(AE --- Adverse Event) 药品严重不良事件(SAE---Serious Adverse Event) 妊娠报告(Pregnancy Notification) 破盲 30 Oct. 2006 Excel PharmaStudies Inc. * 药品不良事件（AE） 病人或临床试验受试者在用药过程中发生的任何不利的医疗事件，该事件并非一定与该药的使用有因果关系。 ICH-GCP 1.2 30 Oct. 2006 Excel PharmaStudies Inc. * 不良事件（AE） AE可以是不利的症状、体征、疾病和实验室检查结果，AE包括： 研究访视中新发生的AE 相对于基线发生频率和严重度加重的AE AE不包括: 研究方案中规定的与研究疾病相关事件 进入研究前已有的症状在研究中仍存在但无进一步加重 30 Oct. 2006 Excel PharmaStudies Inc. * 不良事件的记录 不良事件的描述 发生和终止的时间 转归 程度及发作频度 对不良事件采取的措施 研究者判定不良事件是否与试验药品有关。 30 Oct. 2006 Excel PharmaStudies Inc. * 描述