竞彩足球网

基础知识

医疗器械临床试验现场核查迎审要点

FABUSHIJIAN:2022-03-04  LIULAN:CI

  为贯彻落实国务院《关于改革药品医疗器械审评审批制度的意见》要求,加强医疗器械临床试验过程的监督管理,指导监管部门开展医疗器械临床试验监督检查工作,强化申请人和临床试验机构的法律意识、诚信意识、责任意识和质量意识,根据《医疗器械监督管理条例》《医疗器械注册管理办法》和《医疗器械临床试验质量管理规范》等要求,国家药品监督管理局于2018年11月发布了《医疗器械临床试验检查要点及判定原则》,用于指导医疗器械临床试验现场检查工作。

  真实性合规性问题不容忽视

  《医疗器械临床试验检查要点及判定原则》列出六大方面、66个现场检查要点,涉及临床试验前准备、受试者权益保障、临床试验方案、临床试验过程、记录与报告,以及试验用医疗器械管理等方面。根据各级药监部门发布的历次监督抽查问题公告及笔者参与的一些现场核查实际案例,主要疗效指标及重要安全性指标的评估记录是否真实准确可溯源、入选的人群是否符合入选排除标准、受试者的权益是否得到了有效保护、试验产品是否正确管理及使用等被认为是现场核查的重点内容,申办方及临床试验机构需在项目实际执行及准备迎检时重点关注。

  医疗器械临床试验现场核查发现的常见问题主要有两类,即真实性问题及合规性问题。有以下情形之一的,判定为存在真实性问题:
  1、编造受试者信息、主要试验过程记录、研究数据、检测数据等临床试验数据,影响医疗器械安全性、有效性评价结果的;
  2、临床试验数据,如入选排除标准、主要疗效指标、重要的安全性指标等不能溯源的;
  3、试验用医疗器械不真实,如以对照用医疗器械替代试验用医疗器械、以试验用医疗器械替代对照用医疗器械,以及以其他方式使用虚假试验用医疗器械的;
  4、瞒报与临床试验用医疗器械相关的严重不良事件和可能导致严重不良事件的医疗器械缺陷、使用方案禁用的合并用药或医疗器械的;
  5、注册申请递交的临床试验报告中数据与临床试验机构保存的临床试验报告中的数据不一致,影响医疗器械安全性、有效性评价结果的;
  6、注册申请递交的临床试验统计分析报告中数据与临床试验统计数据库中数据或分中心临床试验小结中数据不一致,影响医疗器械安全性、有效性评价结果的;
  7、其他故意破坏医疗器械临床试验数据真实性的情形。

  WEIFAXIANZHENSHIXINGWENTI,DANLINCHUANGSHIYANGUOCHENGBUFUHEYILIAOQIXIELINCHUANGSHIYANXIANGGUANGUIDINGYAOQIUDE,PANDINGWEICUNZAIHEGUIXINGWENTI。

  对存在真实性问题的,依据《行政许可法》《医疗器械监督管理条例》《医疗器械注册管理办法》《体外诊断试剂注册管理办法》等相关规定进行处理,对相应医疗器械注册申请不予注册。不涉及真实性问题但存在合规性问题的,对注册申请资料和监督检查发现的问题进行安全性、有效性综合评价后,作出是否批准注册的决定。

  YILIAOQIXIELINCHUANGSHIYANFASHENGZHENSHIXINGWENTIHUOYANZHONGHEGUIXINGWENTI,HUIDUILINCHUANGSHIYANGEZHUTIZAOCHENGBUKEWANHUIDESUNSHI。

  做好临床试验全程质量控制

  WEIBIMIANCHUXIANZHENSHIXINGWENTIJIYANZHONGHEGUIXINGWENTI,ZAIXIANGMUZHIXINGQUANGUOCHENGZHONGYAOZUODAOLIANGHAODEZHILIANGKONGZHI。JUTIERYAN——

  1、针对项目执行不同阶段的要求

  LINCHUANGSHIYANQIANZHUNBEIJIEDUAN,XIANGMUFUZERENXUGENJUXIANGMUQINGKUANGZHIDINGYOUZHENDUIXINGDEZHILIANGGUANLIJIHUA,QUEBAOZHENGQUEZHIXINGBIAOZHUN;ZAIXIANGMUQIDONGJIYUNXINGQUANGUOCHENGZHONGTONGGUOFANFUPEIXUNKAOHE,QUEBAOXIANGMUZHIXINGTUANDUIYANGEANZHAOYINIDINGDEZHIXINGBIAOZHUNYUNXING,BINGJIEHEPDCASIWEI,JIYUJIANCHA、XIETONGJIANCHA、DUOJIZHIKONGDENGFANGSHIDUIJIDINGZHILIANGGUANLIJIHUADEYICONGXINGJINXINGFANFUJIANSHI,CUNZAIPIANCHAZHICHUJISHICAIQUJIUZHENGYUFANGCUOSHI,YIQIXIANGMUDADAOLIANGHAODEFAGUI、GCP、FANGAN、SOPJIJIHUAYICONGXING;YINRUJICHA,JIETIQIANANZHAOXIANCHANGJIANCHAYAODIANWANCHENGXIANGMUZICHAHUOMONIXIANCHANGHECHADENGFANGSHI,CHONGFENBAOLUXIANGMUCUNZAIDEWENTI,ZAISHUJUSHENHEJIETIJIEDUANCHONGFENTANTAOPINGGUCUNZAIXIACIDESHUJUDEZHENGTICHULISILU,BINGZAITIJIAOJIANGUANBUMENDEZONGJIEBAOGAOZHONGCHONGFENCHENGXIAN、TANTAO、LUNZHENGQIDUICHANPINANQUANXINGHEYOUXIAOXINGDEYINGXIANG,YILIYUJIANGUANBUMENQUANMIANZHUNQUEPINGGUCHANPINDEANQUANXINGHEYOUXIAOXING。

  2、针对不同性质核查问题的要求

  ZAIZHENSHIXINGWENTIFANGMIAN,CANYULINCHUANGSHIYANDEGEFANGXUBINGCHIJINGWEISHENGMING、JINGWEIZHIZE、JINGWEIGUIZHANGDECHUXIN,ZUODAOBUBIANZAOLINCHUANGSHIYANSHUJU;QUEBAOLINCHUANGSHIYANSHUJUKESUYUAN;QUEBAOSHIYANQIXIEBEIZHENGQUESHIYONG;BUMANBAOYUSHIYANQIXIEXIANGGUANDEYANZHONGBULIANGSHIJIAN、QIXIEQUEXIAN、WEIJINZHILIAO;QUEBAOZHUCESHENBAOZILIAOZHONGSHUJUYUGEZHONGXINBAOCUNDESHUJUYIZHI、TONGJIFENXIBAOGAOZHONGSHUJUYUSHUJUKUZHONGSHUJUJIFENZHONGXINXIAOJIESHUJUYIZHIDENG。ZAIHEGUIXINGWENTIFANGMIAN,XIANGMUZUCHENGYUANYINGJINGGUOYANGEPEIXUNHESHOUQUAN,BINGSHULIANZHANGWOXIANGGUANFALVFAGUIHEFANGANDEJUTIYAOQIU。XIANGMUZHIXINGGUOCHENGYINGYOUCHENGSHUDEBIAOZHUNCAOZUOGUICHENGZUOWEIZHIYIN。CIWAI,LINCHUANGSHIYANGEZHUTIJIANLIWANSHANDEZHILIANGBAOZHENGTIXISHIQUEBAOXIANGMUGAOZHILIANGWANCHENGDEJISHI。

  充分准备迎接现场核查

  YILIAOQIXIELINCHUANGSHIYANXIANCHANGHECHASHINISHANGSHIYILIAOQIXIEWANCHENGZHUCESHENPINGBUZHOUQIANDEGUANJIANHUANJIE,YINCI,YOUTIAOBUWENDIYINGJIEXIANCHANGHECHAZHIGUANZHONGYAO。BIZHECONGYIXIASIFANGMIANFENBIECHANSHUXIANCHANGHECHAGUOCHENGJIYINGSHENYAODIAN:

  1、收到核查通知

  YILIAOQIXIELINCHUANGSHIYANXIANCHANGHECHAYIBANKEFENWEICHANGGUICHOUCHAHEYOUYINHECHA。YIBANLAISHUO,SHENBANFANGJILINCHUANGSHIYANYANJIUJIGOUJIEDAOYAOJIANBUMENDEHECHATONGZHIHOU3~7TIANNEIJIKAIZHANJIANCHA。

  2、搭建迎审团队

  YINGJIANZHUNBEISHIJIANYOUXIAN,ZAISHOUDAOHECHATONGZHIHOU,XIANGMUZUXUJINKUAIDAJIANYINGSHENTUANDUI。TUANDUIYINGBAOKUOSHENBANFANG、LINCHUANGSHIYANYANJIUZHONGXIN(HANJIGOUBANTUANDUI、LUNLIBANTUANDUI、ZHUYAOYANJIUZHEYANJIUTUANDUI)、CRO、SMO、SHUJUGUANLIJITONGJIFENXIDANWEI、ZHONGXINSHIYANSHI(RUOYOU)、YUEPIANZHONGXIN(RUOYOU)DENGSUOYOUSHEJILINCHUANGSHIYANCAOZUODEGECANYUFANG。

  3、核查准备

  ZAIDAJIANYINGSHENTUANDUIDETONGSHI,XIANGMUFUZERENZUOWEISHENBANFANGXIANGMUGUANLIDEHEXIN,XUZHIDINGZHENGTIYINGSHENJIHUA。ZHIDINGYINGSHENJIHUASHI,YINGYISHUNLIYINGJIANWEIMUBIAO,JIANGXUWANCHENGDEXIANCHANGHECHAQIANZHUNBEIGONGZUOJINXINGFENXIHESHULI、HUIZONGWBSBIAODAN,MEIXIANGGONGZUOTIAOMUDUIYINGFENPEITUANDUIZHONGDEXIANGYINGCHENGYUANZUOWEIFUZEREN,MINGQUEFUZERENSUOXUWANCHENGDEGONGZUONEIRONGHEFANWEI、SHIXIAN、YAOQIU。XIANGMUFUZERENYINGGENJURENWUFENPEIQINGKUANGJIZHONGHUOYOUZHENDUIXINGDIDUIXIANGGUANRENWUFUZERENJINXINGPEIXUNGOUTONGHERENWUXIAFA。YOUYUZHUNBEISHIJIANJINZHANG,RUJIHUAGENGXIN,XIANGMUZUYINGJISHIYUXIANGGUANRENWUFUZERENGOUTONG,LUOSHIJIHUABIANGENGANPAI。

  XIANCHANGHECHAQIANZHUNBEIGONGZUOYINGBAOKUODANBUXIANYUZHUNBEIXIANCHANGHECHASHIYONGDEXIANGMUJIESHAONEIRONG、ZHENGLIJICHENLIELINCHUANGSHIYANWENJIAN(BAOKUOCUNFANGJIGOUBAN、LUNLIHEZHUANYEZUKESHIDESHIYANZHIZHIZILIAOHEDIANZIZILIAO)、RENYUANPEIXUNDENG(YIJUHECHAZHONGDIANZHENDUIXINGPEIXUNXIANGMUZUJILINCHUANGSHIYANZHONGXINDUIYINGSHOUQUANRENYUAN)。

  GEFUZERENYINGBENZHEZHENSHI、ZHUNQUE、FUZEDETAIDU,HUIGUSHIYANZHENSHIYUNXINGCAOZUO。

  4、现场迎检

  XIANCHANGYINGJIANYOUSHOUCIHUIYI、XIANCHANGJIANCHA、JIAOLIUWENDAHEMOCIHUIYISIBUFENZUCHENG。XIANCHANGHECHADANGTIAN,YINGJIANDANWEIXUTIQIANCHENLIESUOYOULINCHUANGSHIYANWENJIANYIGONGBEICHA。SHOUCIHUIYISHI,XUXIANGJIANCHAYUANTUANDUIHUIBAOXIANGMUXIANGGUANQINGKUANG。SHOUCIHUIYIHOUJIJINRUXIANCHANGJIANCHAHUANJIE。XIANCHANGJIANCHAGUOCHENGZHONG,JIANCHAYUANKEYULINCHUANGSHIYANJIGOUDELINCHUANGSHIYANGUANLIBUMENRENYUANHUOZHESHIYANRENYUANJINXINGJIAOLIU,LEJIESHIYANQINGKUANG。ZAIJIAOLIUHUANJIE,LINCHUANGSHIYANZHONGXINSHIDAYIZHUTI。ZAIJIANCHAYUANTICHUWENTIHOU,LINCHUANGSHIYANZHONGXINXIANGGUANRENYUANFANCHAGAIWENTISHEJIYUANWENJIANDEQIANHOUJILU,ZUODAYIHUIFU,JIYUSHISHIHEHUXIANGZUNZHONGDEQIANTI,BENZHEYIJIANCUGAIDEXINTAI,RONGQIALIMAODIJINXINGGOUTONG、XUXINQINGJIAOJITINGQUJIANCHAYUANJIANYI,PEIHESHUNLIWANCHENGHECHARENWU。

  DANGRAN,WULUNZAIDUOZAIHAODESHIHOUBUJIUCUOSHI,DOUBURUJIAOTASHIDIZOUHAOLINCHUANGSHIYANMEIYIBU。BUBAOJIAOXINGXINLI,ZHENSHI、HEGUIDIKAIZHANLINCHUANGSHIYAN,CAISHISHUNLITONGGUOXIANCHANGHECHADE“JIBENPAN”。


站点声明:

本网站所提供的信息仅供参考之用,并不代表本网赞同其观点,也不代表本网对其真实性负责。图片版权归原作者所有,如有侵权请联系我们,我们立刻删除。如有关于作品内容、版权或其它问题请于作品发表后的30日内与本站联系,本网将迅速给您回应并做相关处理。
北京飞速度医疗科技有限公司专注于医疗器械、诊断试剂产品政策与法规规事务服务,提供产品注册申报代理、临床合同(CRO)研究、产品研发、GMP质量辅导等方面的技术外包服务。

相关推荐

ONE-STOP SERVICE

一站式服务
在线留言

免费赠送3万家医疗器械企业名录