环球体育

通知公告

環球體育關于成立臨床試驗倫理審查委員會的通知

總醫院各科室、部門:

weiquebaolinchuangshiyanguochengguifan,jieguokexuekekao,baohushoushizhedezunyan、quanyiheanquan,tishengshengwuyixueyanjiudekexuehelunlibiaozhun,techenglilinchuangshiyanlunlishenchaweiyuanhui,gechengyuanrenqiwei: 2021nian1yue11rizhi2024nian1yue10ri。

yi、 linchuangshiyanlunlishenchaweiyuanhuirenyuanshezhi

主任委員: 高巖芳(女)

fuzhurenweiyuan: huangpeili luo wei

秘 書: 高 波 張曉杰(女)

委 員: 董建軍 郭 星 高 波 郭潤青 黃 海 梁海英(女) 任建業(女) 李 力(女) 肖潤平(女) 任玉卿(女) 鄭慶艾(女) 王彥紅(女) 王 軍 王曉榮(女) 王志榮 劉  霞(女) 胡志宏 張曉杰(女) 

linchuangshiyanlunlishenchaweiyuanhuixiashebangongshi,zailinchuangshiyanlunlishenchaweiyuanhuizhurenweiyuandelingdaoxia,youlinchuangshiyanlunlishenchaweiyuanhuimishufuzerichangxingzhengguanligongzuo。

er、linchuangshiyanlunlishenchaweiyuanhuizhize

1.linchuangshiyanlunlishenchaweiyuanhuifuzeduiyaopinjiyiliaoqixielinchuangshiyanxiangmufangandekexuexing、lunlihelixingjinxingshencha。

2.congbaozhangshoushizhequanyidejiaodu,yangeanyaoqiushenyishiyanfangan。baokuochushishencha,genzongshenchahefushen。duipizhundelinchuangyanjiujinxinggenzongshencha,zhuyaoneirongyouxiuzhengfanganshencha、(niandu/dingqi)genzongshencha、yanzhongbuliangshijianyufeiyuqishijianbaogaoshencha、yanjiuzhebuyicong/weifanyanjiufangandeshencha、tiqianzhongzhiyanjiubaogaoshenchahejietibaogaoshencha。

fujian:

1、linchuangshiyanlunlishenchaweiyuanhuizhangcheng

2、linchuangshiyanlunlishenchagongzuochengxu

3、linchuangshiyanlunlishenchaweiyuanhuiweiyuanyugongzuorenyuanxinxibiao

4、linchuangshiyanlunlishenchaweiyuanhuitongxunfangshi

huanqiutiyu

2021nian1yue11ri


fujian1:

huanqiutiyuguanfangwangzhanzongyiyuan

linchuangshiyanlunlishenchaweiyuanhuizhangcheng


章 總 則

第一條 為保護臨床試驗受試者的合法權益,加強對臨床試驗倫理審查委員會臨床試驗倫理審查工作的指導和監督管理,規范倫理審查委員會的臨床試驗的倫理審查工作,保證臨床試驗符合科學和倫理道德要求,根據國家藥品監督管理局《臨床試驗質量管理規范》(GCP)和《臨床試驗倫理審查工作指導原則》以及《赫爾辛基宣言》和世界衛生組織《生物醫學研究審查倫理委員會操作指南》,CIOMS《人體生物醫學研究國際倫理指南》等法律法規,特制定本章程。

第二條 臨床試驗倫理審查委員會對臨床試驗項目的科學性、倫理合理性進行審查,旨在為受試者提供尊嚴、安全和權益的保證,促進臨床試驗科學、健康地發展,增強公眾對臨床試驗的信任和支持。

第三條 環球體育官方網站總醫院臨床試驗倫理審查委員會須在遵守國家憲法、法律、法規和有關規定的前提下,獨立開展臨床試驗的倫理審查工作,并接受藥品監督管理部門的指導和監督。


dierzhang zuzhiyuzujian

disitiao lunlishenchaweiyuanhuimingchenghuanqiutiyuguanfangwangzhanzongyiyuanlinchuangshiyanlunlishenchaweiyuanhui。

diwutiao linchuangshiyanlunlishenchaweiyuanhuidizhiyangquanshibeidajie 218 haohuanqiutiyuguanfangwangzhanzongyiyuan6haolou 603 shi

diliutiao zuzhijiagou linchuangshiyanlunlishenchaweiyuanhuilishuyuhuanqiutiyuguanfangwangzhanzongyiyuan,shiduilinchuangshiyanjinxinglunlishenchadezhuanmenjigou,duihuanqiutiyuguanfangwangzhanzongyiyuanfuze。lunlishenchaweiyuanhuiyouzhurenweiyuan、fuzhurenweiyuan、mishuheweiyuanzucheng,lunlishenchaweiyuanhuixiashebangongshi,zailunlishenchaweiyuanhuizhurenweiyuandelingdaoxia,youlunlishenchaweiyuanhuimishufuzelunlishenchaweiyuanhuirichangxingzhengshiwudeguanligongzuo。

diqitiao xingzhengziyuan yiyuanweilinchuangshiyanlunlishenchaweiyuanhuitigongdulidebangongshi,biyaobangongtiaojian,youkeliyongdedanganshihehuiyishi,yimanzuqizhinengdexuyao。yiyuanweiweiyuan、mishu、duliguwentigongchongfendepeixun,shiqinenggoushengrengongzuo。

dibatiao weiyuanzucheng linchuangshiyanlunlishenchaweiyuanhuiweiyuandezuchengyushuliangyingyusuoshenchaxiangmudezhuanyeleibieheshuliangxiangpipei,weiyuanleibiebaokuoyiyaozhuanye、feiyiyaozhuanye、yuyiyuanbucunzaixingzhenglishuguanxidewaidanweirenyuan、falvzhuanjiayijibutongxingbiedeweiyuan。huanjie、renmianzhurenweiyuan、fuzhurenweiyuan、weiyuancaiqutuijianherenmingxiangjiehedefangshichansheng。zhurenweiyuan、fuzhurenweiyuan、weiyuanderenminghemianchuxujinghuanqiutiyuguanfangwangzhanzongyiyuanpizhun。meijielunlishenchaweiyuanhuirenqi 3 nian。

dijiutiao zhurenweiyuan linchuangshiyanlunlishenchaweiyuanhuishezhurenweiyuan 1 ming、fuzhurenweiyuan 2 ming,zhurenweiyuanhefuzhurenweiyuanyouweiyuanxuanjuchansheng,bingyouyiyuanrenming。zhurenweiyuanfuzezhuchishenchahuiyi,shenqianhuiyijilu,shenqianjuedingwenjian。zhurenweiyuanyuqitaweiyuanzhijianbushiguanliyubeiguanlideguanxi。zhurenweiyuanyingubunenglvxingzhizeshi,keyiweituofuzhurenweiyuanquanbuhuobufenlvxingzhize。

dishitiao linchuangshiyanlunlishenchaweiyuanhuibangongshihemishu lunlishenchaweiyuanhuishebangongshi,mishu 2 ming,fuzerichangxingzhengshiwudeguanligongzuo。

dishiyitiao duliguwen ruguoyinshenchaxuyao,lunlishenchaweiyuanhuihuankepinqingduliguwen。duliguwenyingtijiaobenrenjianli、zizhizhengmingwenjian,qianshubaomixieyiyuliyichongtushengming,duliguwenyingyaoduilinchuangyanjiuxiangmumouxiefangmiandewentitigongzixunyijian,danbujubiaojuequan。


disanzhang zhizeyuquanli

dishiertiao zhize linchuangshiyanlunlishenchaweiyuanhuiyingdangduishenqingrentijiaodelinchuangshiyanxiangmudelunliwentijinxingduli、gongzheng、gongpinghejishideshencha。

dishisantiao quanli linchuangshiyanlunlishenchaweiyuanhuideyunxingbixuduliyushenbanzhe、yanjiuzhe,bingbimianrenhebushideyingxiang。youquanpizhun/bupizhunyixianglinchuangshiyan;duipizhundelinchuangshiyanjinxinggenzongshencha;zhongzhihuozantingyijingpizhundelinchuangshiyan。


disizhang yun  zuo

dishisitiao shenchafangshi linchuangshiyanlunlishenchaweiyuanhuideshenchafangshiyouhuiyishencha、jinjihuiyishenchahekuaisushencha,shixingzhushenzhi,weimeigeshenchaxiangmuanpaizhushenweiyuan。huiyishenchashilunlishenchaweiyuanhuizhuyaodeshenchagongzuofangshi,dingqizhaokaishenchahuiyi。weiyuanzaihuiqianyushensongshenxiangmu,yanjiuguochengzhongchuxianzhongdahuoyanzhongwenti,weijishoushizheanquan,yingzhaokaijinjihuiyishencha。kuaisushenchashihuiyishenchadebuchongxingshi,mudeshiweiletigaogongzuoxiaolv,zhuyaoshiyongyubudayuzuixiaofengxiandeyanjiuxiangmu、yanjiufangandejiaoxiaoxiuzheng、buyingxiangyanjiufengxianshouyibi、shangweinarushoushizhehuoyiwanchengganyucuoshideyanjiuxiangmuyijiyuqiyanzhongbuliangshijianshencha。

dishiwutiao shenchachengxu linchuangshiyanlunlishenchaweiyuanhuijieshoudaoyanjiuxiangmuhou,jinxingxiangmushouli、chuli、shencha、chuandajueding、wenjiancundang。shenchaxiangmubaokuo: yanjiufangandeshejiyushishi;shiyandefengxianyushouyi;shoushizhedezhaomu;zhiqingtongyishugaozhidexinxi;zhiqingtongyideguocheng;shoushizhedeyiliaohebaohu;yinsihebaomi;shejiruoshiquntideyanjiu。yanjiulunlishenchaleibiebaokuochushishencha、genzongshenchahefushen。

dishiliutiao fadingrenshufading daohuirenshuweilunlishenchaweiyuanhuiweiyuanshudesanfenzhier,daohuiweiyuanyingbaokuoyiyaozhuanye、feiyiyaozhuanye、falvyijiduliyuyanjiujigouzhiwaideweiyuan,bingyoubutongxingbiedeweiyuan。

dishiqitiao liyichongtuguanli zunxunliyichongtuzhengce,yuyanjiuxiangmucunzailiyichongtudeweiyuan/duliguwenyingzhudongshengmingbingtuichugaixiangmudetaolunhejuedingchengxu。

dishibatiao shenchajueding songshenwenjianqiquan,taolunhetoupiaoshi,shenqingrenhecunzailiyichongtudeweiyuanlichang,toupiaoweiyuanfuhefadingrenshu,anshenchayaosuheshenchazhongdianjinxingchongfenshenchataolunhou,yitoupiaofangshizuochujueding,meiyoucanjiahuiyitaolundeweiyuanbunengtoupiao。chaoguoquantiweiyuanbanshuyishangdeweiyuantongyipizhundexiangmufangkezuoweilunlishenchaweiyuanhuipizhundexiangmuyuyishishi,huihoujishichuandashenchajuedingheyijian。yanjiuzhehuoyanjiuliyixiangguanfangduilunlishenchaweiyuanhuideshenchajuedingyoubutongyijianshikeyitijiaofushen,yulunlishenchaweiyuanhuiweiyuanhebangongshigoutongjiaoliu。

dishijiutiao baomi linchuangshiyanlunlishenchaweiyuanhuiweiyuan/duliguwenyingduisongshenwenjianfuyoubaomizerenheyiwu,shenchawanchenghou,jishijiaohuisuoyousongshenwenjianyushenchacailiao,budesizifuyinyuwaichuan。

diershitiao xiezhu yiyuansuoyouyushoushizhebaohudexiangguanbumenyingxietonglunlishenchaweiyuanhuidegongzuo,baozhengshoushizhedejiankanghequanyidedaobaohu;baozhengkaizhanyanjiuzhongsuoshejidezuzhijigoudeliyichongtu、weiyuanheyanjiurenyuandegerenliyichongtudedaozuidachengdudejianshaohuoxiaochu,youxiaobaogaohechuliweibeifaguiyufangandeqingkuang;jianlishoushizhe、yanjiuzhehuoyanjiuliyixiangguanfangmianyouxiaodegoutongqudao,duiqisuoguanxindewentihesuqiuzuochuhuiying。lunlishenchaweiyuanhuiyingjianliyuqitajigoulunlishenchaweiyuanhuiyouxiaodegoutonghejiaoliujizhi,xiezhuwanchengduozhongxinlinchuangyanjiudeshencha。

diershiyitiao zhiliangguanli linchuangshiyanlunlishenchaweiyuanhuijieshouyiyuanzhiliangguanlibumenduilunlishenchaweiyuanhuigongzuozhiliangdejianchahepinggu;jieshouweishengxingzhengbumen、yaopinjiandujianchabumendejianduguanli;jieshoudulide、waibudezhiliangpingguhuorenzheng。lunlishenchaweiyuanhuiduijianchafaxiandewenticaiquxiangyingdegaijincuoshi。

diershiertiao jianduguanli linchuangshiyanlunlishenchaweiyuanhuizhurenweiyuanxiangfenguangongzuodeyuanlingdaohuibaogongzuo,xiangyiyuan、yaopinjianduguanlibumenbaogaolunlishenchaqingkuang。duilunlishenchaweiyuanhuiweifanfaguide“tongyi”jueding,yiyuanbangonghuikeyaoqiulunlishenchaweiyuanhuizhongshenhuozhongzhipizhundeyanjiuxiangmu。


diwuzhang pingshenfeiyong

diershisantiao pingshenfeiyong xianglunlishenchaweiyuanhuidijiaopingshencailiaodetongshi,xuxianghuanqiutiyuguanfangwangzhanzongyiyuanjingyingguanlikezhidingzhanghujiaonapingshenfei,youyiyuancaizhengbumenkaijutongyiyinfadepiaoju,yongyupingshenzhuanjialaowufeikaizhi。

diliuzhang weiyuandepeixun

diershisitiao peixunhejixujiaoyu huanqiutiyuguanfangwangzhanzongyiyuanweilinchuangshiyanlunlishenchaweiyuanhuiweiyuandepeixunhejixujiaoyuchuangzaotiaojian,weiyuanmeiniandoubixujieshoujixujiaoyu,tongguokaohehegequdegcpyulunlishenchapeixunzhengshu,buduantigaoduirentishengwuyixueyanjiuxiangmujinxingkexueshenchahelunlishenchadenengli。peixunhegedeweiyuantongyibingqianshuweiyuanshengming、liyichongtushengming,baomixieyi,bingtongyigongkaizijidexingming、zhiyehelishujigoudeng。


diqizhang wendangguanli

diershiwutiao ziliaodanganshi linchuangshiyanlunlishenchaweiyuanhuijianlidulideziliaodanganshi,youmishujigongzuorenyuanfuzewendangziliaoguanli,baokuofuzebenbumenwenjianziliaodeshouji、zhengli、fenlei、baocun、guidanghejieyue/fuyindengshiwu。

diershiliutiao danganziliaobaocun  ziliaobaocunbixumanzufanghuo、fangshui、

fangdao、fangchong、fangshuhewenshidudengyibaozhengdanganziliaodeanquan。ziliaodangan

shiwendubaochichangwen、shidukongzhizai35%~75%,meirijiancebingjilu1ci。

diershiqitiao  anquanguanli  danganshipeibeishangsuodewenjianjuyongyucunfangdanganleiwenjian,danganshidamenyaochihewenjianjuyaochiyoumishubaoguan,jinruziliaodanganshixuyaoyouzhuanrenpeitong,youguanlirenyuandiaoqu,zhidingdidianchayue,fuyinyoumishudaiban。

diershibatiao  yanjiuxiangmuwenjiandechayueyufuyin  anzhaoshenqing——pizhun——diaoqu——chayue/fuyindeliucheng,wanchenghou,lijiguihuanwenjian,mishushenchaziliaodewanzhengxing,bingzaishenqingbiaoshangqianshuxingmingheriqi,guidangbaocun。

diershijiutiao  danganbaocunqixian  yanjiuxiangmuleiwenjianzhishaobaocunzhixiangmuwanchenghou5nian;lunlishenchaweiyuanhuiqitawenjiandanganbaocun10nian;qimanhouruguojihuaxiaohuiwenjian,xuyaozhurenweiyuanyuyanjiuzhe、shenbanzhesanfangqianzi。

disanshitiaofangwenquanxian  feilinchuangshiyanlunlishenchaweiyuanhuichengyuanfangwenjimileiwenjian,xuyaojingguofuzhurenweiyuanshenhepizhun,bingqianshubaomixieyi;feiweiyuanhemishufangwenmimileiwenjian,xuyaojingguomishutongyi,biyaoshiqianshubaomixieyi;feiweiyuanhemishufangwenneibuwenjian,xuyaojingguomishutongyi。


fujian2:

huanqiutiyuguanfangwangzhanzongyiyuanlinchuangshiyan

lunlishenchagongzuochengxu


weizhidaozhuyaoyanjiuzhe/shenbanzhe、lunlishenchaweiyuanguifan、youxu、yanjindekaizhangongzuo,genjuguojiaweishenghejihuashengyuweiyuanhui《shejirendeshengwuyixueyanjiulunlishenchabanfa》、guojiayaopinjianduguanlizongju《linchuangshiyanzhiliangguanliguifan》、《linchuangshiyanlunlishenchagongzuozhidaoyuanze》dengfalvfagui,tezhidinghuanqiutiyulinchuangshiyanlunlishenchagongzuochengxu。

一、倫理審查申請/報告的類別

(yi)chushishencha

chushishenchazhichucitijiaolunlishenchadelinchuangshiyanyanjiuxiangmu,yanjiukaishiqiantijiaolunlishenchashenqing,jingpizhunhoufangkeshishi。

(er)genzongshencha

genzongshenchazhilinchuangshiyanlunlishenchaweiyuanhuiduisuoyoupizhundelinchuangshiyanjinxinggenzongshencha,zhizhishiyanjieshu,jutibaokuo:

1、修正方案審查: 適用于對臨床試驗倫理審查委員會已經批準的研究方案進行的修改,包括修改研究方案、修改知情同意書、增減研究人員、增減研究中心等。

2、(niandu/dingqi)genzongshencha: shiyongyuduilinchuangshiyanlunlishenchaweiyuanhuisuoyoupizhundeyanjiuxiangmude(niandu/dingqi)genzongshencha,genzongshenchazhishaomeinianyici。

shenqingrenyinganzhaolunlishenchapijian/yijianguidingde(niandu/dingqi)genzongshenchapinlv,zaijiezhiriqiqian1geyuetijiaoyanjiujinzhanbaogao。dangchuxianrenhekenengxianzhuyingxiangshiyanjinxinghuozengjiashoushizheweixiandeqingkuangshi,yingyi“yanjiujinzhanbaogao”defangshijishibaogaogeilinchuangshiyanlunlishenchaweiyuanhui。

3、yanzhongbuliangshijianyufeiyuqishijianbaogaoshencha: shiyongyushejibenlinchuangshiyanlunlishenchaweiyuanhuipizhundelinchuangyanjiuzhongfashengdeyanzhongbuliangshijian、feiyuqishijiandeshencha,baokuoyoushenbanzhe、yanjiuzhe、jianchayuan、linchuangshiyanlunlishenchaweiyuanhuiweiyuanhuoqitarentijiaodeyanzhongbuliangshijianhefeiyuqishijian。

4、研究者不依從/違反研究方案審查: 適用于對臨床試驗倫理審查委員會批準的研究項目在開展過程中發生的不依從/違反研究方案,包括研究者/研究機構不按照批準的研究方案實施研究,不遵守相關法規和國際指南,以及不遵守本臨床試驗倫理審查委員會有關保護受試者的要求。

5、tiqianzhongzhishiyanshencha: shiyongyuduilinchuangshiyanlunlishenchaweiyuanhuipizhundesuoyouyanjiu,zaiyuandingjihuawanchengyanjiuzhiqianjibeijianyihuojuedingzhongzhideyanjiuxiangmu,baokuozhuyaoyanjiuzhe、shenbanzhe、linchuangshiyanlunlishenchaweiyuanhui、yanjiuzhuguanbumendengjianyidezhongzhiyanjiu。

6、jietishencha: shiyongyuduilinchuangshiyanlunlishenchaweiyuanhuishenchapizhundeyanjiuxiangmuwanchenghoudejietibaogaoshencha

(san)zaicisongshen

shiyongyuzaicisongshenxiangmu,baokuohuiyishenchazuochu“zuobiyaodexiuzhenghoutongyi”juedingdeyanjiuxiangmu。zhuyaoyanjiuzheyingzaishoudaoxiugaiyijianhou2geyueneitijiaozaicisongshenfanganwenjian。

er、lunlishenchafangshi

linchuangshiyanlunlishenchaweiyuanhuideshenchafangshiyouhuiyishencha、jinjihuiyishenchahekuaisushencha,shixingzhushenzhi,meigeshenchaxiangmuanpaizhushenweiyuan。

(yi)huiyishenchahejinjihuiyishencha

huiyishenchashilunlishenchazhuyaodeshenchagongzuofangshi,dingqizhaokaishenchahuiyi,yibanxiangmushoulihoubuchaoguo4zhou。yanjiuguochengzhongchuxianzhongdahuoyanzhongwenti,weijishoushizheanquan,yingzhaokaijinjihuiyishencha。

(er)kuaisushencha

kuaisushenchashihuiyishenchadebuchongxingshi,mudeshiweiletigaogongzuoxiaolv,zhuyaoshiyongyubudayuzuixiaofengxiandeyanjiuxiangmu、yanjiufangandejiaoxiaoxiuzheng、buyingxiangyanjiufengxianshouyibi、shangweinarushoushizhehuoyiwanchengganyucuoshideyanjiuxiangmuyijiyuqiyanzhongbuliangshijianshencha。

san、lunlishenchaliucheng

(yi)shouli

研究項目的主要研究者按照藥物臨床研究倫理審查申請/送審文件清單(附表)遞交送審文件并填寫倫理審查申請表,報送臨床試驗倫理審查委員會辦公室,臨床試驗倫理審查委員會秘書對申請文件完成形式審查、登記,對送審材料進行受理編號并填寫受理與審查通知函。

(er)chuli

臨床試驗倫理審查委員會秘書根據倫理審查申請/報告的類別進行處理,確定審查方式,向主任委員推薦主審委員/獨立顧問,經主任委員授權的主審委員/獨立顧問對研究項目進行初審,并填寫審查工作表。審查內容包括:

1、yanjiufangandeshejiyushishi;

2、shiyandefengxianyushouyi;

3、shoushizhedezhaomu;

4、zhiqingtongyishugaozhidexinxi;

5、zhiqingtongyideguocheng;

6、shoushizhedeyiliaohebaohu;

7、yinsihebaomi;

8、shejiruoshiquntideyanjiu。

(san)shencha

1、kuaisushencha

shiyiyukuaisushenchadelinchuangshiyanxiangmu,2mingzhushenweiyuanshishikuaisushenchabingtianxiexiangyingdeshenchagongzuobiao,2mingweiyuanshenchayijianyizhiwei“tongyi”shi,zhunbeishenchapijian,dijiaozhurenweiyuanshenhe;2mingweiyuanshenchayijianbuyizhihuoshenchayijianwei“zuobiyaodexiuzhenghoutongyi”“butongyi”“tijiaohuiyishencha”shizezhuanweihuiyishenchafangshi。

2、huiyishencha

shiyiyuhuiyishenchadelinchuangshiyanxiangmujingzhushenweiyuanyushenjiqitacanhuiweiyuanhuiqianshenchahou,youzhurenweiyuanquedinghuiyiriqiheshijian(ruyujinjiqingkuang,genjuzhurenweiyuanjueding,linshianpaijinjihuiyi),mishulianxicanhuiweiyuantongshizhunbeihuiyiyichenghehuiyiziliao,biyaodehuiyiyingjianshebeiquanbudaowei。

zhurenweiyuanzhuchishenchahuiyi,keyiyunxuqitarenliexihuiyi,liexizheqianshu“baomixieyi”。daohuiweiyuanfuhefadingrenshu,tixingshengmingliyichongtu。huiyiliuchengyicijinxing:

  申請者依據“倫理審查申請報告”,簡要報告;

  臨床試驗倫理審查委員會委員提問,申請者回答;

  根據生效的保密協議,獨立顧問可應邀與會或提供書面意見;

☆ 主要研究者、申辦者和獨立顧問離場;

  與審查項目存在利益沖突的委員離場;

  主審委員進行評議;

  臨床試驗倫理審查委員會充分審查和討論;

  投票決定;

mishugenjuhuiyijiluhetoupiaojieguo,qicaoshenchajuedingwenjian,baoqingzhurenweiyuanshenchaqianfa。

(si)chuandajueding

“lunlishenchapijian”yuanjian1fen、fubenduofen(anshenbanzhe、linchuangshiyanjigoushuquedingfubenshu)jiagailinchuangshiyanlunlishenchaweiyuanhuigongzhang,songdashenqingren。

1、kendingxingjuedingdechuanda

10gegongzuorineisongdazhuyaoshenqingren。

2、tiaojianxingjuedingdechuanda

duiyuzuobiyaodexiuzhenghoutongyi: shenqingrenanzhaoyaoqiuduiyanjiufanganjinxingxiugaihou,zaicitijiaolinchuangshiyanlunlishenchaweiyuanhuibangongshi,jinglinchuangshiyanlunlishenchaweiyuanhuimishuhezhushenweiyuanqueren,zhurenweiyuanshenchaqianshupijian,wuxuzhongfanxiayicilinchuangshiyanlunlishenchaweiyuanhuihuiyijinxingshencha;

3、foudingxingjuedingdechuanda

lunlishenchapijianyujuedinghou10gegongzuorineisongdazhuyaoshenqingren;

shenqingrenduishenchajuedingdebutongyijian

shenqingrenruduishenchajuedingyoubutongyijian,shumianxianglinchuangshiyanlunlishenchaweiyuanhuifanying;

zhurenweiyuanjiangrenzhenkaolvshensuyijian,biyaoshianpaiduishensuxiangmujinxingfushen。

(wu)wenjianbaocun

shoujibaocunlinchuangshiyanxiangmudexiangguanwenjian,baokuolunlishenchashenqingcailiao;shenchagongzuobiao;duliguwenshenchabaogao;linchuangshiyanlunlishenchaweiyuanhuihuiyiqiandaobiao;shenchapijian/shenchayijian;linchuangshiyanlunlishenchaweiyuanhuiyushenqingrenhuoqitayouguanrenyuanjiushenqing、shenchahegenzongshenchawentidewanglaixinjian;toupiaodan;huiyijilufuben;xianchangjianchabaogaodengziliao,wenjianzhishaobaocunzhixiangmuwanchenghou5nian。


fubiao:

huanqiutiyuguanfangwangzhanzongyiyuanyaowu/yiliaoqixielinchuangyanjiulunlishenchashenqing/songshenwenjianqingdan

yi、(chushi)lunlishenchashenqing

(yi)yaowu(zhuce)linchuangyanjiulunlishenchashenqingwenjianqingdan

1

lunlishenchashenqingbiao(shenqingzheqianmingbingzhumingriqi,yanjiuzheyaozhumingyanjiujingjiliyishengming)qita;

2

shenbanfangzizhizhengming

3

linchuangyanjiufangan(zhumingbanbenhao/banbenriqi)

4

zhiqingtongyishu(zhumingbanbenhao/banbenriqi)

5

zhaomushoushizhedecailiao(zhumingbanbenhao/banbenriqi,baokuoguanggao)

6

binglibaogaobiao(zhumingbanbenhao/banbenriqi)

7

yanjiuzheshouce(xubaokuolinchuangqianduli、yaoxiaoziliao)

8

zhuyaoyanjiuzhezhuanyelvli

9

zuchangdanweilinchuangshiyanlunlishenchaweiyuanhuipijian

10

qitalinchuangshiyanlunlishenchaweiyuanhuiduishenqingyanjiuxiangmudezhongyaojueding

11

nmpadelinchuangyanjiupijian(youxiao)

12

baoxianhetong

13

linchuangshiyanjigoupizhunkaizhangaishiyandezhengming

14

qita

suoyouwenjiantijiaozhizhiban1fen(lunlibeian),dianziban1fen。

tijiaodecailiaoqinganzhaoqingdandeshunxuyicipailie,bingzaidiyiyecharumulu。


keyanxiangmulunlishenchashenqingwenjianqingdan

1

keyanlunlishenchashenqingbiao(shenqingzheqianmingbingzhumingriqi,yanjiuzheyaozhumingyanjiujingjiliyishengming)

2

linchuangyanjiufangan(zhumingbanbenhao/banbenriqi)

jijinzizhuxiangmu: xutigongrenwuhetongshu

feijijinxiangmu: xutigongzhuanjiatongxingpingyishu

3

linchuangyanjiufanganzhiqingtongyishu(zhumingbanbenhao/banbenriqi)

4

zhaomushoushizhedecailiao(zhumingbanbenhao/banbenriqi)

5

binglibaogaobiao(zhumingbanbenhao/banbenriqi)

6

yanjiuzheshouce(ruyou)

7

zhuyaoyanjiuzhezhuanyelvli

8

zuchangdanweilinchuangshiyanlunlishenchaweiyuanhuipijian

9

qitalinchuangshiyanlunlishenchaweiyuanhuihuoguanlijigouduishenqingyanjiuxiangmudezhongyaojueding(ruyou)

10

linchuangshiyanjigoupizhunkaizhangaishiyandezhengming

11

qita

suoyouwenjiantijiaodianziban1fen。

tijiaodecailiaoqinganzhaoqingdandeshunxuyicipailie,bingzaidiyiyecharumulu


(er)yiliaoqixie(zhuce)linchuangyanjiulunlishenchashenqingwenjianqingdan

1

lunlishenchashenqingbiao(shenqingzheqianmingbingzhumingriqi,yanjiuzheyaozhumingyanjiujingjiliyishengming)

2

shiyongdejishuyaoqiu

3

zijianhegebaogao

4

zhucejianyanhegebaogao

5

臨床試驗方案(注明版本號/版本日期)

6

yanjiuzheshouce

7

知情同意書文本和其他提供給受試者的書面材料(注明版本號/版本日期)

8

受試者招募文件(注明版本號/版本日期,包括廣告

9

yanjiuzhezigezhengmingwenjian

10

病例報告表文本(注明版本號/版本日期)

11

linchuangshiyanjigoudesheshitiaojiannenggoumanzushiyandezongshu

12

shenbanzhejidailiren(ruyou)zizhizhengmingwenjian

13

shiyanyongyiliaoqixiedeyanzhifuheshiyongdeyiliaoqixiezhiliangguanlitixixiangguanyaoqiudeshengming

14

shenbanzhebaozhengsuotigongziliaozhenshixingdeshengming

15

yanjiuzhebaozhengsuotigongziliaozhenshixingdeshengming

16

qitayulunlishenchaxiangguandecailiao

suoyouwenjiantijiaozhizhiban1fen(lunlibeian),dianziban1fen。

tijiaodecailiaoqinganzhaoqingdandeshunxuyicipailie,bingzaidiyiyecharumulu。


keyanxiangmulunlishenchashenqingwenjianqingdan

1

keyanlunlishenchashenqingbiao(shenqingzheqianmingbingzhumingriqi,yanjiuzheyaozhumingyanjiujingjiliyishengming)

2

shiyongdejishuyaoqiu

3

zijianhegebaogao

4

zhucejianyanhegebaogao

5

linchuangshiyanfangan(zhumingbanbenhao/banbenriqi)

jijinzizhuxiangmu: xutigongrenwuhetongshu

feijijinxiangmu: xutigongzhuanjiatongxingpingyishu

6

yanjiuzheshouce

7

zhiqingtongyishuwenbenheqitatigonggeishoushizhedeshumiancailiao(zhumingbanbenhao/banbenriqi)

8

shoushizhezhaomuwenjian(zhumingbanbenhao/banbenriqi,baokuoguanggao)

9

yanjiuzhezigezhengmingwenjian

10

binglibaogaobiaowenben(zhumingbanbenhao/banbenriqi)

11

linchuangshiyanjigoudesheshitiaojiannenggoumanzushiyandezongshu

12

shenbanzhejidailiren(ruyou)zizhizhengmingwenjian

13

shiyanyongyiliaoqixiedeyanzhifuheshiyongdeyiliaoqixiezhiliangguanlitixixiangguanyaoqiudeshengming

14

shenbanzhebaozhengsuotigongziliaozhenshixingdeshengming

15

yanjiuzhebaozhengsuotigongziliaozhenshixingdeshengming

16

qitayulunlishenchaxiangguandecailiao

suoyouwenjiantijiaodianziban1fen。

tijiaodecailiaoqinganzhaoqingdandeshunxuyicipailie,bingzaidiyiyecharumulu


er、genzongshencha

anshenchayijianxiuzhengfangandezaicisongshenwenjianqingdan

1

anshenchayijianxiuzhengfangandezaicishenchashenqingbiao

2

xiugaidecailiao,rulinchuangyanjiufangan(zhumingbanbenhao/riqi),zhiqingtongyishu(zhumingbanbenhao/riqi): duixiugaibufenyixieti、yinyinghuohuaxiandefangshibiaoji

3

qita

suoyouwenjiantijiaozhizhiban1fen(lunlibeian),dianziban1fen。


xiuzhengfanganlunlishenchashenqingwenjianqingdan

1

xiuzhengfanganlunlishenchashenqingbiao

2

linchuangyanjiufanganxiudingshuomingye——feizhongyaoneirongxiuzhengyijishaoliangneirongxiuzhengxutijiao

3

xiuzhengdelinchuangyanjiufangan(zhumingbanbenhaohebanbenriqi)——zhongyaoneirongxiuzhengyijidaliangneirongxiuzhengxutijiao,duixiugaibufenyixieti、yinyinghuohuaxiandefangshibiaoji

4

xiuzhengdezhiqingtongyishu(zhumingbanbenhaohebanbenriqi)——zhongyaoneirongxiuzhengyijidaliangneirongxiuzhengxutijiao,duixiugaibufenyixieti、yinyinghuohuaxiandefangshibiaoji

5

xiuzhengdezhaomucailiao

6

qita

yishangwenjianshiyoulunlimishuzuochubushencha,juedingshenchafangshi。


yanzhongbuliangshijianshenchawenjianqingdan

1

yanzhongbuliangshijianbaogaobiao

2

qitazhongxinfashengdefeiyuqideyaowuyanzhongbuliangfanying,songshenwenjianxubaokuogaizhongxindelunlishenchayijian(ruyou)

suoyouwenjiantijiaozhizhiban1fen(lunlibeian),dianziban1fen。


(niandu/dingqi)genzongshenchawenjianqingdan

1

(niandu/dingqi)genzongshenchashenqingbaogao

2

dangqianshiyongdezhiqingtongyishu

3

fabiaowenzhang(ruyou)

suoyouwenjiantijiaozhizhiban1fen(lunlibeian),dianziban1fen。


yanjiuzhebuyicong/weifanyanjiufangandeshenchawenjianqingdan

1

yanjiuzhebuyicong/weifanyanjiufangandebaogao

suoyouwenjiantijiaozhizhiban1fen(lunlibeian),dianziban1fen。


tiqianzhongzhiyanjiubaogaoshenchawenjianqingdan

1

tiqianzhongzhiyanjiujilu

2

jietibaogao

suoyouwenjiantijiaozhizhiban1fen(lunlibeian),dianziban1fen。


jietibaogaoshenchawenjianqingdan

1

jietibaogao

2

yanjiuzongjiebaogao(dianziban,ruyou)

suoyouwenjiantijiaozhizhiban1fen(lunlibeian),dianziban1fen。



環球體育官方網站總醫院臨床試驗倫理審查委員會

委員與工作人員信息表

序號

 姓名

xingbie

zhuanye

lunlishenchaweiyuanhuizhiwu

gongzuodanwei

1

gaoyanfang

nv

yaoxue

lunliweiyuanhuizhuren

yangmeizongyuandangweifushuji、jiweishuji、gonghuizhuxi

2

huangpeili

nan

xiaohua

lunliweiyuanhuifuzhuren

yangmeizongyuanfuyuanchang

3

luowei

nan

xueguanwaike

lunliweiyuanhuifuzhuren

yangmeizongyuanfuyuanchang

4

gaobo

nan

yaoxue

lunlimishu

yangmeizongyuanyaoxuebu

5

zhangxiaojie

nv

yaoxue

lunlimishu

yangmeizongyuanyaoxuebu

6

huzhihong

nan

jianyan

lunliweiyuan

yangmeizongyuankejiaoke

7

dongjianjun

nan

yiliaoguanli

lunliweiyuan

yangmeizongyuanyiwuke

8

guoxing

nan

jisuanji

lunliweiyuan

shanxiguangdianyangmeifengongsi

9

liuxia

nv

yaoxue

lunliweiyuan

yangmeizongyuanyaoxuebu

10

guorunqing

nan

falvzixun

lunliweiyuan

yangmeizongyuanyiwuke

11

huanghai

nan

guke

lunliweiyuan

yangmeizongyuanguke

12

wangjun

nan

zuzhi

lunliweiyuan

yangmeizongyuandangqunbu

13

lianghaiying

nv

huli

lunliweiyuan

yangmeizongyuanhulibu

14

renjianye

nv

yaoxue

lunliweiyuan

yangmeizongyuanyaoxuebu

15

lili

nv

zhongliu

lunliweiyuan

yangmeizongyuanzhongliuneike

16

xiaorunping

nv

xinxueguan

lunliweiyuan

yangmeizongyuanxinneierbingqu

17

renyuqing

nv

shenbing

lunliweiyuan

yangmeizongyuanshenbingneike

18

zhengqingai

nv

fuchanke

lunliweiyuan

yangmeizongyuanfuchanke

19

wangyanhong

nv

neifenmi

lunliweiyuan

yangmeizongyuanneifenmike

20

wangxiaorong

nv

caihui

lunliweiyuan

yangmeizongyuanbangongshi

21

wangzhirong

nan

falv

lunliweiyuan

shanxizhenanlvshishiwusuo


fujian4:

環球體育官方網站總醫院臨床試驗倫理審查委員會通訊方式

dizhi: huanqiutiyuguanfangwangzhanzongyiyuan6haolou603shi

youbian: 045000

lianxidianhua: 0353-7078200

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