GD真人

《医疗器械临床试验质量管理规范》
作者: 本站编辑  来源:GD真人 - GD真人厅 发布日期: 2015-03-07 00:03:33 【

《yiliaoqixielinchuangshiyanzhiliangguanliguifan》yijingguojiashipinyaopinjianduguanlizongjujuwuhuiyi、guojiaweishenghejihuashengyuweiyuanhuiweizhurenhuiyishenyitongguo,xianyugongbu,zi2016nian6yue1riqishixing。

ju zhang bijingquan

                                                          zhu ren libin

                                                            2016nian3yue1ri

GD真人yiliaoqixielinchuangshiyanzhiliangguanliguifan

diyizhang zong ze

  diyitiao weijiaqiangduiyiliaoqixielinchuangshiyandeguanli,weihuyiliaoqixielinchuangshiyanguochengzhongshoushizhequanyi,baozhengyiliaoqixielinchuangshiyanguochengguifan,jieguozhenshi、kexue、kekaohekezhuisu,genju《yiliaoqixiejianduguanlitiaoli》,zhidingbenguifan。

GD真人  diertiao zaizhonghuarenmingongheguojingneigdzhenrenyiliaoqixielinchuangshiyan,yingdangzunxunbenguifan。

benguifanhangaiyiliaoqixielinchuangshiyanquanguocheng,baokuolinchuangshiyandefangansheji、shishi、jiancha、hecha、jiancha,yijishujudecaiji、jilu,fenxizongjiehebaogaodeng。

  disantiao benguifansuochengyiliaoqixielinchuangshiyan,shizhizaijingzizhirendingdeyiliaoqixielinchuangshiyanjigouzhong,duinishenqingzhucedeyiliaoqixiezaizhengchangshiyongtiaojianxiadeanquanxingheyouxiaoxingjinxingquerenhuozheyanzhengdeguocheng。

  disitiao yiliaoqixielinchuangshiyanyingdangzunxunyifayuanze、lunliyuanzehekexueyuanze。

GD真人  diwutiao shengjiyishangshipinyaopinjianduguanlibumenfuzeduiyiliaoqixielinchuangshiyandejianduguanli。

  weishengjishengzhuguanbumenzaizhizefanweineijiaqiangduiyiliaoqixielinchuangshiyandeguanli。

GD真人  shipinyaopinjianduguanlibumen、weishengjishengzhuguanbumenyingdangjianliyiliaoqixielinchuangshiyanzhiliangguanlixinxitongbaojizhi,jiaqiangdisanleiyiliaoqixie、lieruguojiadaxingyiyongshebeipeizhiguanlipinmudeyiliaoqixiegdzhenrenlinchuangshiyanshenpiqingkuangyijixiangyingdelinchuangshiyanjianduguanlishujudexinxitongbao。

dierzhang linchuangshiyanqianzhunbei

  diliutiao jinxingyiliaoqixielinchuangshiyanyingdangyouchongfendekexueyijuhemingquedeshiyanmude,bingquanhengduishoushizhehegongzhongjiankangyuqideshouyiyijifengxian,yuqideshouyiyingdangchaoguokenengchuxiandesunhai。

GD真人  diqitiao linchuangshiyanqian,shenbanzheyingdangwanchengshiyanyongyiliaoqixiedelinchuangqianyanjiu,baokuochanpinsheji(jiegouzucheng、gongzuoyuanlihezuoyongjili、yuqiyongtuyijishiyongfanwei、shiyongdejishuyaoqiu)hezhiliangjianyan、dongwushiyanyijifengxianfenxideng,qiejieguoyingdangnenggouzhichigaixianglinchuangshiyan。zhiliangjianyanjieguobaokuozijianbaogaohejuyouzizhidejianyanjigouchujudeyinianneidechanpinzhucejianyanhegebaogao。

  dibatiao linchuangshiyanqian,shenbanzheyingdangzhunbeichongzudeshiyanyongyiliaoqixie。shiyanyongyiliaoqixiedeyanzhiyingdangfuheshiyongdeyiliaoqixiezhiliangguanlitixixiangguanyaoqiu。

  dijiutiao yiliaoqixielinchuangshiyanyingdangzailianggehuozhelianggeyishangyiliaoqixielinchuangshiyanjigouzhongjinxing。

GD真人  suoxuanzedeshiyanjigouyingdangshijingzizhirendingdeyiliaoqixielinchuangshiyanjigou,qiesheshihetiaojianyingdangmanzuanquanyouxiaodijinxinglinchuangshiyandexuyao。yanjiuzheyingdangjubeichengdangaixianglinchuangshiyandezhuanyetezhang、zigehenengli,bingjingguopeixun。

GD真人  yiliaoqixielinchuangshiyanjigouzizhirendingguanlibanfayouguojiashipinyaopinjianduguanlizongjuhuitongguojiaweishenghejihuashengyuweiyuanhuilingxingzhiding。

GD真人  dishitiao linchuangshiyanqian,shenbanzheyulinchuangshiyanjigouheyanjiuzheyingdangjiushiyansheji、shiyanzhiliangkongzhi、shiyanzhongdezhizefengong、shenbanzhechengdandelinchuangshiyanxiangguanfeiyongyijishiyanzhongkenengfashengdeshanghaichuliyuanzedengdachengshumianxieyi。

  dishiyitiao linchuangshiyanyingdanghuodeyiliaoqixielinchuangshiyanjigoulunliweiyuanhuidetongyi。lieruxujinxinglinchuangshiyanshenpidedisanleiyiliaoqixiemulude,haiyingdanghuodeguojiashipinyaopinjianduguanlizongjudepizhun。

  dishiertiao linchuangshiyanqian,shenbanzheyingdangxiangsuozaidisheng、zizhiqu、zhixiashishipinyaopinjianduguanlibumenbeian。

  jieshoubeiandeshipinyaopinjianduguanlibumenyingdangjiangbeianqingkuangtongbaolinchuangshiyanjigousuozaididetongjishipinyaopinjianduguanlibumenyijiweishengjishengzhuguanbumen。

disanzhang shoushizhequanyibaozhang

  dishisantiao yiliaoqixielinchuangshiyanyingdangzunxun《shijieyixuedahuiheerxinjixuanyan》quedingdelunlizhunze。

GD真人  dishisitiao lunlishenchayuzhiqingtongyishibaozhangshoushizhequanyidezhuyaocuoshi。

GD真人  canyulinchuangshiyandegefangyingdanganzhaoshiyanzhonggezidezhizechengdanxiangyingdelunlizeren。

  dishiwutiao shenbanzheyingdangbimianduishoushizhe、linchuangshiyanjigouheyanjiuzhedenglinchuangshiyancanyuzhehuozhexiangguanfangchanshengbudangyingxianghuozhewudao。

GD真人  linchuangshiyanjigouheyanjiuzheyingdangbimianduishoushizhe、shenbanzhedenglinchuangshiyancanyuzhehuozhexiangguanfangchanshengbudangyingxianghuozhewudao。

  dishiliutiao shenbanzhe、linchuangshiyanjigouheyanjiuzhebudekuadacanyulinchuangshiyandebuchangcuoshi,wudaoshoushizhecanyulinchuangshiyan。

  dishiqitiao linchuangshiyanqian,shenbanzheyingdangtongguoyanjiuzhehelinchuangshiyanjigoudeyiliaoqixielinchuangshiyanguanlibumenxianglunliweiyuanhuitijiaoxialiewenjian:

  (yi)linchuangshiyanfangan;

GD真人  (er)yanjiuzheshouce;

  (san)zhiqingtongyishuwenbenheqitarenhetigongjishoushizhedeshumiancailiao;

  (si)zhaomushoushizhehexiangqixuanchuandechengxuxingwenjian;

  (wu)binglibaogaobiaowenben; 

  (liu)zijianbaogaohechanpinzhucejianyanbaogao;

  (qi)yanjiuzhejianli、zhuanyetezhang、nengli、jieshoupeixunheqitanenggouzhengmingqizigedewenjian;

GD真人  (ba)linchuangshiyanjigoudesheshihetiaojiannenggoumanzushiyandezongshu;

GD真人  (jiu)shiyanyongyiliaoqixiedeyanzhifuheshiyongdeyiliaoqixiezhiliangguanlitixixiangguanyaoqiudeshengming;

  (shi)yulunlishenchaxiangguandeqitawenjian。

GD真人  lunliweiyuanhuiyingdangbingchenglunlihekexuedeyuanze,shenchahejiandulinchuangshiyandeshishi。

  dishibatiao zailinchuangshiyanguochengzhongfashengxialieqingkuangzhiyide,yanjiuzheyingdangjishixianglinchuangshiyanjigoudeyiliaoqixielinchuangshiyanguanlibumenbaogao,bingjingqijishitongbaoshenbanzhe、baogaolunliweiyuanhui:

  (yi)yanzhongbuliangshijian;

  (er)jindubaogao,baokuoanquanxingzongjiehepianlibaogao;

  (san)duilunliweiyuanhuiyipizhunwenjianderenhexiuding,buyingxiangshoushizhequanyi、anquanhejiankang,huozheyulinchuangshiyanmudehuozhongdianbuxiangguandefeishizhixinggaibianwuxushiqianbaogao,danshihouyingdangshumiangaozhi;

  (si)zanting、zhongzhihuozhezantinghouqingqiuhuifulinchuangshiyan;

  (wu)yingxiangshoushizhequanyi、anquanhejiankanghuozhelinchuangshiyankexuexingdelinchuangshiyanfanganpianli,baokuoqingqiupianlihebaogaopianli。

  weibaohushoushizhequanyi、anquanhejiankang,zaijinjiqingkuangxiafashengdepianliwufajishibaogaode,yingdangzaishihouyishumianxingshijinkuaianzhaoxiangguanguidingbaogao。

GD真人  dishijiutiao linchuangshiyanguochengzhong,ruxiudinglinchuangshiyanfanganyijizhiqingtongyishudengwenjian、qingqiupianli、huifuyizantinglinchuangshiyan,yingdangzaihuodelunliweiyuanhuideshumianpizhunhoufangkejixushishi。

  diershitiao yingdangjinliangbimianxuanquweichengnianren、yunfu、laonianren、zhilizhangairenyuan、chuyushengmingweijiqingkuangdehuanzhedengzuoweishoushizhe;quexuxuanqushi,yingdangzunshoulunliweiyuanhuitichudeyouguanfujiayaoqiu,zailinchuangshiyanzhongzhenduiqijiankangzhuangkuangjinxingzhuanmensheji,bingyingdangyouyiyuqijiankang。

  diershiyitiao zaishoushizhecanyulinchuangshiyanqian,yanjiuzheyingdangchongfenxiangshoushizhehuozhewuminshixingweinengliren、xianzhiminshixingweinenglirendejianhurenshuominglinchuangshiyandexiangxiqingkuang,baokuoyizhide、keyiyujiandefengxianhekenengfashengdebuliangshijiandeng。jingchongfenhexiangxijieshihouyoushoushizhehuozheqijianhurenzaizhiqingtongyishushangqianshuxingmingheriqi,yanjiuzheyexuzaizhiqingtongyishushangqianshuxingmingheriqi。

GD真人  diershiertiao zhiqingtongyishuyibanyingdangbaokuoxialieneirongyijiduishixiangdeshuoming:

GD真人  (yi)yanjiuzhedexingmingyijixiangguanxinxi;

  (er)linchuangshiyanjigoudemingcheng;

  (san)shiyanmingcheng、mude、fangfa、neirong;

  (si)shiyanguocheng、qixian;

GD真人  (wu)shiyandezijinlaiyuan、kenengdeliyichongtu;

GD真人  (liu)yuqishoushizhekenengdeshouyiheyizhide、keyiyujiandefengxianyijikenengfashengdebuliangshijian;

  (qi)shoushizhekeyihuodedetidaizhenliaofangfayijiqiqianzaishouyihefengxiandexinxi;

  (ba)xuyaoshi,shuomingshoushizhekenengbeifenpeidaoshiyandebutongzubie;

  (jiu)shoushizhecanjiashiyanyingdangshiziyuande,qiezaishiyanderenhejieduanyouquantuichuerbuhuishoudaoqishihuozhebaofu,qiyiliaodaiyuyuquanyibushouyingxiang;

  (shi)gaozhishoushizhecanjiashiyandegerenziliaoshuyubaomi,danlunliweiyuanhui、shipinyaopinjianduguanlibumen、weishengjishengzhuguanbumenhuozheshenbanzhezaigongzuoxuyaoshianzhaoguidingchengxukeyichayueshoushizhecanjiashiyandegerenziliao;

GD真人  (shiyi)rufashengyushiyanxiangguandeshanghai,shoushizhekeyihuodezhiliaohejingjibuchang;

GD真人  (shier)shoushizhezaishiyanqijiankeyisuishilejieyuqiyouguandexinxiziliao;

GD真人  (shisan)shoushizhezaishiyanqijiankenenghuodedemianfeizhenliaoxiangmuheqitaxiangguanbuzhu。

  zhiqingtongyishuyingdangcaiyongshoushizhehuozhejianhurennenggoulijiedeyuyanhewenzi。zhiqingtongyishubuyingdanghanyouhuiyinqishoushizhefangqihefaquanyiyijimianchulinchuangshiyanjigouheyanjiuzhe、shenbanzhehuozheqidailirenyingdangfuzerendeneirong。

  diershisantiao huodezhiqingtongyihaiyingdangfuhexialieyaoqiu:

  (yi)duiwuxingweinenglideshoushizhe,ruguolunliweiyuanhuiyuanzeshangtongyi、yanjiuzherenweishoushizhecanjialinchuangshiyanfuheqizishenliyishi,yekeyijinrulinchuangshiyan,danshiyanqianyingdangyouqijianhurenqianmingbingzhumingriqi;

  (er)shoushizhehuozheqijianhurenjunwuyuedunenglishi,zaizhiqingguochengzhongyingdangyouyimingjianzhengrenzaichang,jingguoxiangxijieshizhiqingtongyishuhou,jianzhengrenyueduzhiqingtongyishuyukoutouzhiqingneirongyizhi,youshoushizhehuozheqijianhurenkoutoutongyihou,jianzhengrenzaizhiqingtongyishushangqianmingbingzhumingriqi,jianzhengrendeqianmingyuyanjiuzhedeqianmingyingdangzaitongyitian;

  (san)weichengnianrenzuoweishoushizhe,yingdangzhengdeqijianhurendezhiqingtongyibingqianshuzhiqingtongyishu,weichengnianrennengduishifoucanjiashiyanzuochuyisibiaoshide,haiyingdangzhengdeqibenrentongyi;

  (si)rufaxianshejishiyanyongyiliaoqixiedezhongyaoxinxihuozheyuqiyiwaidelinchuangyingxiang,yingdangduizhiqingtongyishuxiangguanneirongjinxingxiugai,xiugaidezhiqingtongyishujinglunliweiyuanhuirenkehou,yingdangyoushoushizhehuozheqijianhurenzhongxinqianmingqueren。

GD真人  diershisitiao zhiqingtongyishuyingdangzhumingzhidingderiqihuozhexiudinghoubanbenderiqi。ruzhiqingtongyishuzaishiyanguochengzhongyouxiuding,xiudingbandezhiqingtongyishuzhixingqianxuzaicijinglunliweiyuanhuitongyi。xiudingbandezhiqingtongyishubaolinchuangshiyanjigouhou,suoyouweijieshushiyanliuchengdeshoushizherushouyingxiang,douyingdangqianshuxinxiudingdezhiqingtongyishu。

GD真人  diershiwutiao shoushizheyouquanzailinchuangshiyanderenhejieduantuichubingbuchengdanrenhejingjizeren。

disizhang linchuangshiyanfangan

GD真人  diershiliutiao gdzhenrenyiliaoqixielinchuangshiyan,shenbanzheyingdanganzhaoshiyanyongyiliaoqixiedeleibie、fengxian、yuqiyongtudenggdzhenrenzhidingkexue、helidelinchuangshiyanfangan。

  diershiqitiao weizaijingneiwaipizhunshangshidexinchanpin,anquanxingyijixingnengshangweijingyixuezhengshide,linchuangshiyanfanganshejishiyingdangxianjinxingxiaoyangbenkexingxingshiyan,daichubuquerenqianquanxinghou,zaigenjutongjixueyaoqiuquedingyangbenlianggdzhenrenhouxulinchuangshiyan。

GD真人  diershibatiao yiliaoqixielinchuangshiyanfanganyingdangbaokuoxialieneirong:

  (yi)yibanxinxi;

  (er)linchuangshiyandebeijingziliao;

  (san)shiyanmude;

  (si)shiyansheji;

GD真人  (wu)anquanxingpingjiafangfa;

GD真人  (liu)youxiaoxingpingjiafangfa;

GD真人  (qi)tongjixuekaolv;

  (ba)duilinchuangshiyanfanganxiuzhengdeguiding;

  (jiu)duibuliangshijianheqixiequexianbaogaodeguiding;

  (shi)zhijiefangwenyuanshuju、wenjian;

  (shiyi)linchuangshiyanshejidelunliwentiheshuomingyijizhiqingtongyishuwenben;

GD真人  (shier)shujuchuliyujilubaocun;

GD真人  (shisan)caiwuhebaoxian;

GD真人  (shisi)shiyanjieguofabiaoyueding。

GD真人  shangshubufenneirongkeyibaokuozaifangandeqitaxiangguanwenjianruyanjiuzheshoucezhong。linchuangshiyanjigoudejutixinxi、shiyanjieguofabiaoyueding、caiwuhebaoxiankeyizaishiyanfanganzhongbiaoshu,yekeyilingxingzhidingxieyijiayiguiding。

  diershijiutiao duozhongxinlinchuangshiyanyouduoweiyanjiuzheanzhaotongyishiyanfanganzaibutongdelinchuangshiyanjigouzhongtongqijinxing。qishiyanfangandeshejiheshishiyingdangzhishaobaokuoyixianeirong:

  (yi)shiyanfanganyoushenbanzhegdzhenrenzhidingbingjinggelinchuangshiyanjigouyijiyanjiuzhegongtongtaolunrending,qiemingqueqiantoudanweilinchuangshiyanjigoudeyanjiuzheweixiediaoyanjiuzhe;

  (er)xiediaoyanjiuzhefuzelinchuangshiyanguochengzhonggelinchuangshiyanjigoujiandegongzuoxiediao,zailinchuangshiyanqianqi、zhongqihehouqigdzhenrenyanjiuzhehuiyi,bingyushenbanzhegongtongduizhenggeshiyandeshishifuze;

  (san)gelinchuangshiyanjigouyuanzeshangyingdangtongqigdzhenrenhejieshulinchuangshiyan;

  (si)gelinchuangshiyanjigoushiyanyangbenliangyijifenpei、fuhetongjifenxiyaoqiudeliyou;

GD真人  (wu)shenbanzhehelinchuangshiyanjigouduishiyanpeixundejihuayupeixunjiluyaoqiu;

  (liu)jianlishiyanshujuchuandi、guanli、hechayuchaxunchengxu,youqimingqueyaoqiugelinchuangshiyanjigoushiyanshujuyouguanziliaoyingdangyouqiantoudanweijizhongguanliyufenxi;

GD真人  (qi)duozhongxinlinchuangshiyanjieshuhou,gelinchuangshiyanjigouyanjiuzheyingdangfenbiechujulinchuangshiyanxiaojie,liantongbinglibaogaobiaoanguidingjingshenhehoujiaoyouxiediaoyanjiuzhehuizongwanchengzongjiebaogao。

GD真人diwuzhang lunliweiyuanhuizhize

GD真人  disanshitiao yiliaoqixielinchuangshiyanjigoulunliweiyuanhuiyingdangzhishaoyou5mingweiyuanzucheng,baokuoyixuezhuanyerenyuan、feiyixuezhuanyerenyuan,qizhongyingdangyoubutongxingbiedeweiyuan。feiyixuezhuanyeweiyuanzhongzhishaoyouyimingweifalvgongzuozhe,yimingweigailinchuangshiyanjigouyiwaiderenyuan。lunliweiyuanhuiweiyuanyingdangjuyoupingguhepingjiagaixianglinchuangshiyandekexue、yixuehelunlixuedengfangmiandezigehuozhejingyan。suoyouweiyuanyingdangshuxiyiliaoqixielinchuangshiyandelunlizhunzehexiangguanguiding,bingzunshoulunliweiyuanhuidezhangcheng。

GD真人  disanshiyitiao yiliaoqixielunliweiyuanhuiyingdangzunshou《shijieyixuedahuiheerxinjixuanyan》lunlizhunzeheshipinyaopinjianduguanlibumendeguiding,jianlixiangyingdegongzuochengxubingxingchengwenjian,anzhaogongzuochengxulvxingzhize。

  lunliweiyuanhuizhongduliyuyanjiuzheheshenbanzhedeweiyuanyouquanfabiaoyijianbingcanyuyouguanshiyandebiaojue。

GD真人  disanshiertiao lunliweiyuanhuigdzhenrenhuiyiyingdangshixiantongzhi,canjiapingshenhebiaojuerenshubunengshaoyu5ren,zuochurenhejuedingyingdangyoulunliweiyuanhuizuchengchengyuanbanshuyishangtongguo。

  yanjiuzhekeyitigongyouguanshiyanderenhefangmiandexinxi,danbuyingdangcanyupingshen、toupiaohuozhefabiaoyijian。

GD真人  lunliweiyuanhuizaishenchamouxieteshushiyanshi,keyiyaoqingxiangguanlingyudezhuanjiacanjia。

  disanshisantiao lunliweiyuanhuiyingdangcongbaozhangshoushizhequanyidejiaoduyangeshenyishiyanfanganyijixiangguanwenjian,bingyingdangzhongdianguanzhuxialieneirong:

  (yi)yanjiuzhedezige、jingyanyijishifouyouchongfendeshijiancanjiagailinchuangshiyan。

GD真人  (er)linchuangshiyanjigouderenyuanpeibeiyijishebeitiaojiandengshifoufuheshiyanyaoqiu。

GD真人  (san)shoushizhekenengzaoshoudefengxianchengduyushiyanyuqideshouyixiangbishifouheshi。

GD真人  (si)shiyanfanganshifouchongfenkaolvlelunliyuanze,shifoufuhekexuexing,baokuoyanjiumudeshifoushidang、shoushizhedequanyishifoudedaobaozhang、qitarenyuankenengzaoshoufengxiandebaohuyijishoushizheruxuandefangfashifoukexue。

  (wu)shoushizheruxuanfangfa,xiangshoushizhehuozheqijianhurentigongdeyouguanbenshiyandexinxiziliaoshifouwanzheng、shoushizheshifoukeyilijie,huoquzhiqingtongyishudefangfashifoushidang;biyaoshi,lunliweiyuanhuiyingdanggdzhenrenshoushirenqundaibiaoduiziliaodekelijiechengdujinxingceshi,pingguzhiqingtongyishifoushidang,pinggujieguoyingdangshumianjilubingbaocunzhilinchuangshiyanjieshuhou10nian。

  (liu)shoushizheruofashengyulinchuangshiyanxiangguandeshanghaihuozhesiwang,jiyudezhiliaohebaoxiancuoshishifouchongfen。

  (qi)duishiyanfangantichudexiugaiyijianshifoukeyijieshou。

GD真人  (ba)shifounenggouzailinchuangshiyanjinxingzhongdingqifenxipingguduishoushizhedekenengweihai。

GD真人  (jiu)duishiyanfangandepianlikenengyingxiangshoushizhequanyi、anquanhejiankang,huozheyingxiangshiyandekexuexing、wanzhengxing,shifoukeyijieshou。

GD真人  disanshisitiao duozhongxinlinchuangshiyandelunlishenchayingdangyouqiantoudanweilunliweiyuanhuifuzejianlixiezuoshenchagongzuochengxu,baozhengshenchagongzuodeyizhixinghejishixing。

GD真人  gelinchuangshiyanjigoushiyankaishiqianyingdangyouqiantoudanweilunliweiyuanhuifuzeshenchashiyanfangandelunlihelixinghekexuexing,canjiashiyandeqitalinchuangshiyanjigoulunliweiyuanhuizaijieshouqiantoudanweilunliweiyuanhuishenchayijiandeqiantixia,keyicaiyonghuiyishenchahuozhewenjianshenchadefangshi,shenchagaixiangshiyanzaibenlinchuangshiyanjigoudekexingxing,baokuoyanjiuzhedezigeyujingyan、shebeiyutiaojiandeng,yibanqingkuangxiabuzaiduishiyanfanganshejitichuxiugaiyijian,danshiyouquanbupizhunzaiqilinchuangshiyanjigoujinxingshiyan。


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