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本院药物临床试验SAE/SUSAR/DSUR 报告流程(试行)

发布时间: 2019-10-14


  weishiyingxinbangcpdeyaoqiu,mingquegefangzhize,guifansae/susardeshangbao、shouji、cundang,zhidingruxialiucheng。

  1. dingyi。

  1、yanzhongbuliangshijian(sae,serious adverse event): zhishoushizhejieshoushiyanyongyaopinhouchuxiansiwang、weijishengming、yongjiuhuozheyanzhongdecanjihuozhegongnengsangshi、shoushizhexuyaozhuyuanzhiliaohuozheyanzhangzhuyuanshijian,yijixiantianxingyichanghuozhechushengquexiandengbuliangyixueshijian。

  2、yaowubuliangfanying(adr,adverse drug reaction):zhilinchuangshiyanzhongfashengderenheyushiyanyongyaokenengyouguandeduirentiyouhaihuozhefeiqiwangdefanying。

  3、keyiqiefeiyuqiyanzhongbuliangfanying(susar,suspected unexpected serious adverse reaction): zhilinchuangbiaoxiandexingzhiheyanzhongchengduchaochuleshiyanyaowuyanjiuzheshouce、yishangshiyaopindeshuomingshuhuozhechanpintexingzhaiyaodengyiyouziliaoxinxidekeyibingqiefeiyuqideyanzhongbuliangfanying。

yabo88  er、yanjiuzhebaogaosae。

  受试者发生SAE后,除试验方案或者其他文件(如研究者手册)中规定不需立即报告的严重不良事件外,研究者应当立即(一般为获知24小时内)向申请人书面报告所有严重不良事件,随后应当及时提供详尽、书面的随访报告。研究者填写电子版《严重不良事件报告表》(附件2),同时报告申请人、本院机构办公室和伦理办公室yabo88。报告时应当使用受试者的鉴认代码。受试者或配偶发生的妊娠事件按SAE流程报告。电子邮件命名格式为“SAE+科室+受试者鉴认代码+项目简称+首次/随访/总结 报告”。

  三、申请人接收、评估并反馈SUSAR报告。

  1、shenqingrenduishoudaodesuoyousaebaogaohouyingdanglijijinxingquanmianfenxi、pinggu。duiyufuhesusarde,shenqingrenxuzaiguidingshixianneixiangyanjiuzhe、jigoubangongshi、lunlibangongshifasongchulihoudesusarbaogaojisuifangbaogao。

  2、致死或危及生命的SUSAR,申请人在获知后首次7天内报告,并在随后的8天内报告、完善随访信息;非致死或危及生命的SUSAR,申请人在首次获知后15天内报告。电子邮件命名格式为“SUSAR+中心名称+受试者鉴认代码+项目简称+首次/随访”。

  3、shenqingrenzaipinggushijiandeyanzhongxinghexiangguanxingshi,ruyuyanjiuzheyoubutongyijianxuxiemingliyou;xiangguanxingpanduanbunengdachengyizhishi,qizhongrenyifangpanduanbunengpaichuyushiyanyaowuxiangguande,yeyingkuaisubaogao。

  si、yanjiuzhejieshou、shenheyuzaibaogao。

yabo88  duiyushenqingrenpingguhoufankuidesusarbaogao,yanjiuzhejieshouhoujinxingshenhe。shenqingrenjiangzhizhibanbaogaojiaoyanjiuzheqianzihou,zaidijiaojigoubangongshihelunlibangongshicundang。

yabo88  wu、yaowuyanfaqijiananquanxinggengxinbaogao(dsur)deshangbao。

yabo88  shenqingrentigongdedsurshiyonggezidebaogaogeshi,yi12geyueyicidepinlvbaogaozhiyanjiuzhe、jigoubangongshihelunlibangongshideyouxiang。

  liu、baogaodeqizhishijian。

  shangshiqianlinchuangyanjiudebaogaokaishishijianweilinchuangshiyanpizhunriqihuomoshixukekaishiriqi;shangshihouyanjiudebaogaokaishishijianweishiyanzhengshiqidonghou。

  baogaojieshushijianweizuihouyilishoushizhejieshusuifangriqi。

yabo88  zhu: linchuangshiyanjieshuhuosuifangjieshuhouzhihuodeshenpingshenpijielunqianfashengdeyanzhongbuliangshijian,youyanjiuzhebaogaoshenqingren,ruoshuyususar,shenqingrenyeyingjinxingkuaisubaogao。

  qi、baogaodeyuyan。

yabo88  wulunjingnei、jingwaideanquanxingshijianyingcaiyongzhongwenbaogao。guojiduozhongxinxiangmuyuanshiziliaoweiyingwende,caiyongzhongyingwenduizhaoxingshibaogao。

  ba、baogaofangshi。

yabo88  weibaozhengjieshoubaogaodeshixiaoxing,suoyoubaogaojunzaidianziyoujianfasonghoulijidianhuatongzhijieshoufang。suoyoubaogaoyidianziyoujianfasongchenggongshijianweizhun,youjianbaogaoliangzhouneibixudijiaozhizhibanbaogao。

  jiu、benzhongxinyouxiang。

  机构办公室: 伦理办公室:

   

       

附件1: 本院SAESUSAR报告流程图.docx

附件2: 严重不良事件报告表(SAE) - 副本.docx


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