[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"$fciMlMSTqotBVkpnHPedeDOBHqPoKwq9YcT0ajDs8b3I":3},{"answer":4,"createTime":5,"id":6,"options":7,"origin":12,"question":19,"related":20,"source":31,"type":32},[],"2024-05-18 16:42:01",144419748,[8,9,10,11],"《药物临床试验期间安全信息评估与管理规范》","《药品定期安全性更新报告撰写规范》","《研发期间安全性更新报告管理规范》","《药物临床试验质量管理规范》",{"count":13,"courseId":14,"courseImg":15,"courseName":16,"workId":17,"workName":18},10,"ff2bd3e0d6ac8850a96c230431b976f0","https:\u002F\u002Ftihai-oss-cloud.itihey.com\u002Fimg\u002Fa9b135010fa59450d68deae94301f003.png","药物警戒实务","54842db49f954655bfbb9ee7d6adf1a1","目标检测9","DSUR需要按照( )的要求撰写",[21,33,42,51,60,63,72,83,93,103],{"answer":22,"createTime":23,"id":24,"options":25,"question":30,"source":31,"type":32},[],"2024-05-18 16:42:00",144419740,[26,27,28,29],"CCDS","DMF","ICH","DMC","临床试验数据监查委员会的英文简称为 ( )","v1",0,{"answer":34,"createTime":5,"id":35,"options":36,"question":41,"source":31,"type":32},[],144419742,[37,38,39,40],"受试者保护原则","临床试验科学性原则","申办者成本原则","研究伦理道德原则","GVP第一百二十条规定,临床试验过程中的安全信息报告、风险评估和风险管理及相关处理,应当严格遵守的原则是( )",{"answer":43,"createTime":5,"id":44,"options":45,"question":50,"source":31,"type":32},[],144419744,[46,47,48,49],"研究者","申办者","CRO","受托方","GVP第一百二十二条规定,申办者为临床试验期间药物警戒责任主体,根据工作需要委托受托方开展药物警戒活动的,相应法律责任由( )承担",{"answer":52,"createTime":5,"id":53,"options":54,"question":59,"source":31,"type":32},[],144419747,[55,56,57,58],"PSUR","ICSR","DSUR","ICH E2F","研发期间安全性更新报告的英文简称为( )",{"answer":61,"createTime":5,"id":6,"options":62,"question":19,"source":31,"type":32},[],[8,9,10,11],{"answer":64,"createTime":5,"id":65,"options":66,"question":71,"source":31,"type":32},[],144419749,[67,68,69,70],"一个月","两个月","三个月","六个月","使用&quot;国际研发诞生日&quot;(DIBD)作为DSUR年度报告周期的起始日期.首次提交研发期间安全性更新报告应当在境内临床试验获准开展后第一个国际研发诞生日后( )内完成",{"answer":73,"createTime":5,"id":74,"options":75,"question":81,"source":31,"type":82},[],144419750,[76,77,78,79,80],"指定专职人员负责临床试验期间的安全信息监测和严重不良事件报告管理","制订临床试验安全信息监测与严重不良事件报告操作规程,并对相关人员进行培训","掌握临床试验过程中最新安全性信息,及时进行安全风险评估,向试验相关方通报有关信息","负责对可疑且非预期严重不良反应和其他潜在的严重安全性风险信息进行快速报告","富有临床治疗经验和GCP合规意识","GVP第一百一十八条规定,申办者应当( )",1,{"answer":84,"createTime":5,"id":85,"options":86,"question":92,"source":31,"type":82},[],144419751,[87,88,89,90,91],"知情同意权","隐私权","医疗救治权","经济补偿权","生命健康权","临床试验过程中受试者权益包括( )",{"answer":94,"createTime":5,"id":95,"options":96,"question":102,"source":31,"type":82},[],144419752,[97,98,99,100,101],"明显影响药品获益-风险评估的","可能考虑药品用法改变的","影响总体药品研发进程的信息,如新的动物试验中重大安全性发现(如致癌性)","对于已知的、严重的不良反应,其发生率增加,判断具有临床重要性","对暴露人群有明显的危害,如在治疗危及生命疾病时药品无效","关于&quot;其他潜在的严重安全性风险信息&quot;,包涵的情形有( )",{"answer":104,"createTime":5,"id":105,"options":106,"question":112,"source":31,"type":82},[],144419753,[107,108,109,110,111],"使用试验药的临床试验,即:临床药理学、治疗探索性及治疗确证性试验(Ⅰ-Ⅲ期)","对上市药物已批准适应症进行的临床试验,即:治疗应用试验Ⅳ期","试验药的治疗应用,如:扩大使用项目、同情使用项目、特殊患者应用、单个患者IND和治疗IND","上市后药品临床使用过程中的安全性信息","支持药品生产工艺变更的临床试验","DSUR应当提供报告周期内申办者所有正在进行的临床试验以及正在实施或已完成的其他研究中的安全性信息,包括( )"]