yabo88

欢迎访问yabo88 今天是
 
您现在的位置: yabo88 > 药物临床试验 > 办事指南

药物临床试验

临床试验监查员(CRA)职责及工作要求

发布时间: 2019-10-14


  genju《yaowulinchuangshiyanzhiliangguanliguifan》(gcp),weijinyibuqianghuacrazhizejiguifanqizaiyabo88guanfangwangzhilinchuangshiyanjigougongzuoshixiang,zhidingbenyaoqiu。

yabo88  genju《yaowulinchuangshiyanzhiliangguanliguifan》(gcp)(guojiashipinyaopinjianduguanlijulingdi 3 hao):

  disanshibatiao shenbanzherenminghegedejianchayuan,bingweiyanjiuzhesuojieshou。

  disishiwutiao jianchademudeshiweilebaozhengzhongshoushizhedequanyishoudaobaozhang,shiyanjiluyubaogaodeshujuzhunque、wanzhengwuwu,baozhengshiyanzunxunyipizhundefanganheyouguanfagui。

yabo88  disishiliutiao jianchayuanshishenbanzheyuyanjiuzhezhijiandezhuyaolianxiren。qirenshujifangshidecishuqujueyulinchuangshiyandefuzachengduhecanyushiyandeyiliaojigoudeshumu。jianchayuanyingyoushidangdeyixue、yaoxuehuoxiangguanzhuanyexueli,bingjingguobiyaodexunlian,shuxiyaopinguanliyouguanfagui,shuxiyouguanshiyanyaowudelinchuangqianhelinchuangfangmiandexinxiyijilinchuangshiyanfanganjiqixiangguandewenjian。

yabo88  disishiqitiao jianchayuanyingzunxunbiaozhuncaozuoguicheng,duculinchuangshiyandejinxing,yibaozhenglinchuangshiyananfanganzhixing。jutineirongbaokuo:

  (yi)zaishiyanqianquerenshiyanchengdandanweiyijuyoushidangdetiaojian,baokuorenyuanpeibeiyupeixunqingkuang,shiyanshishebeiqiquan、yunzhuanlianghao,jubeigezhongyushiyanyouguandejianchatiaojian,gujiyouzugoushuliangdeshoushizhe,canyuyanjiurenyuanshuxishiyanfanganzhongdeyaoqiu;

yabo88  (er)zaishiyanguochengzhongjianchayanjiuzheduishiyanfangandezhixingqingkuang,querenzaishiyanqianqudesuoyoushoushizhedezhiqingtongyishu,lejieshoushizhederuxuanlvjishiyandejinzhanzhuangkuang,querenruxuandeshoushizhehege;

  (san)querensuoyoushujudejiluyubaogaozhengquewanzheng,suoyoubinglibaogaobiaotianxiezhengque,bingyuyizhi。suoyoucuowuhuoyiloujunyigaizhenghuozhuming,jingyanjiuzheqianmingbingzhumingriqi。meiyishoushizhedejilianggaibian、zhiliaobiangeng、hebingyongyao、jianfajibing、shifang、jianchayiloudengjunyingquerenbingjilu。heshiruxuanshoushizhedetuichuyushifangyizaibinglibaogaobiaozhongyuyishuoming;

yabo88  (si)querensuoyoubuliangshijianjunjiluzaian,yanzhongbuliangshijianzaiguidingshijianneizuochubaogaobingjiluzaian;

  (wu)heshishiyanyongyaopinanzhaoyouguanfaguijinxinggongying、chuzang、fenfa、shouhui,bingzuoxiangyingdejilu;

yabo88  (liu)xiezhuyanjiuzhejinxingbiyaodetongzhijishenqingshiyi,xiangshenbanzhebaogaoshiyanshujuhejieguo;

  (qi)yingqingchurushijiluyanjiuzheweinengzuodaodesuifang、weijinxingdeshiyan、weizuodejiancha,yijishifouduicuowu、yilouzuochujiuzheng;

  (ba)meicifangshihouzuoyishumianbaogaodisongshenbanzhe,baogaoyingshumingjianchariqi、shijian、jianchayuanxingming、jianchadefaxiandeng。

yabo88  crayingshuzhiyishangfaguijixiangguanzhize,bingzunshoujigoubanduiqigongzuoyaoqiu。

  yaoqiuruxia:

       1、crayinganjigouyaoqiujinxinggerenziliaobeian,xiangjigoubandijiaoqizhizhiweipaihanhexiangguanzizhizhengming(gaigongzhang),baokuogerenjianlijixuelizheng、shenfenzheng、gcpzhengshudefuyinjian。xuzaidijiaolixiangziliaoshiwancheng。

  2、anjigouyaoqiujinxinglixiangwenjianjiziliaodezhunbei,zhizhifuheyaoqiu。

  3、duiyuxiangmulixianghouziliaoderenhegengxin,ruchucilunlishenchapijian、baokuodanbuxianyulunlizaicishenchahuobeiandexiangguanshiyoudengjunxubaobeijigouban。

yabo88  4、mouxiangmuqidongqiancrayingdijiaojigoubanyabo88gaixiangmudejianchajihua;meicijianchajieshuwugegongzuorineixiangyanjiuzhehejigoubandijiaoqijianchabaogao。

  5、anjigoubanguidingdijiaoxiangmujinzhanqingkuang。

  6、wulunhezhongyuanyin,xiangmucrajinxinggenghuan,xuzhishaotiqianliangzhouxiangjigoubanbaobei。xinrencraxuandi1tiaojinxinggerenziliaobeian。xinjiucraxugongtongdijiaoyabo88xiangmudejiaojiejilufuyinjianjidianzibanzhijigouban。jigoubanpinggufuheyaoqiufangkejinxingjiaojie。

yabo88  7、fashengzhongdatufagonggongweishengshijianshi,crayinganjigoubanyaoqiuzuohaoliuxingbingxuediaocha。

   


友情链接: | |

Copyright 2020 All Rights Reserved yabo88
医院地址: 长沙市开福区营盘路311号