文件4-伦理审查推荐表(中英文对照)-第四版-2012.09.20修订

首都医科大学附属北京佑安医院人体研究保护项目BeijingYouanHospital,CapitalMedicalUniversityHumanResearchProtectionProgram附件15Appendix15首都医科大学附属北京佑安医院临床试验/科学研究/医疗技术伦理审查推荐表(第四版)RECOMMENDATIONFORMFORETHICALREVIEWOFCLINICALTRIAL/SCIENTIFICRESEARCH/MEDICALTECHNOLOGY(Revision4th)修订时间RevisedDate：2012.10.01推荐项目编号RecommendedProjectNo.：项目一般情况Generalinformationontheproject项目名称Protocolname项目来源Protocolsource项目类别Protocoltype□1.新药试验Newdrugtest（临床批件号ClinicalapprovalNo.__________）；2.新器械或医用耗材试验Newinstrumentormedicalsuppliestest；3.新技术试验Newtechnologytest；4.其他Other（请注明pleaseindicate）：新药试验期别（新药适用）Phaseofnewdrugtest(onlyfornewdrug)□1.Ⅰ期Phase-I；2.Ⅱ期Phase-II；3.Ⅲ期Phase-III；4.Ⅳ期Phase-IV；5.其它Other（请注明pleaseindicate）：总负责Overallresponsibility□是Yes□否No多中心Multi-center□否No□是Yes；继续填写continuetocomplete:□国际International□国内Domestic申请审查类别Typeofreview□初审Initialreview□跟踪审查Trackingreview*（伦理批件号EthicalapprovalNo.）:______________□1.作必要的修正后重审ReviewafterrevisedbyEC□2.方案修改后审查Reviewaftertheprotocolrevision□3.知情同意书修改后审查ReviewaftertheICFrevision□4.其它Other(请具体说明pleasespecify：________________________________)申请方一般情况Generalinformationon单位名称Nameofunit单位性质Typeofunit□1.申办方Sponsor，2.CRO单位电话Tel.通讯地址Correspondence首都医科大学附属北京佑安医院人体研究保护项目BeijingYouanHospital,CapitalMedicalUniversityHumanResearchProtectionProgramtheapplicantAdd.联系人姓名ContactName传真Fax手机Mobilephone电子信箱E-mail项目主要研究者基本信息BasicinformationonPrincipalinvestigatoroftheproject姓名Name科室Department办公电话OfficeTel职称TechnicalPost传真Fax手机Mobilephone职务Title电子信箱E-mail主要研究方向Mainresearchdirection目前承担任务Numberofpresenttasks项药物临床试验机构/科研处/医务处审查意见Reviewopinionoftheorganizationforclinicaltestofdrugs/ScientificResearchDivision/DepartmentofMedicalAdministration项目相关资料是否齐全Projectrelateddataarecomplete□是Yes□否No院内正在进行的同类项目数Numberofsimilarprojectsongoinginthehospital项审查专家Reviewexpert项目综合初评等级Gradeofcomprehensiveinitialreview□1.优Excellent；2.良Good；3.中Moderate；伦理审查推荐意见Recommendationopinionfromethicalreview：机构办公室/科研处/医务处主任签字SignedbytheDirectorofOrganizationOffice/ScientificResearchDivision/DepartmentofMedicalAdministration：日期Date：注Note:此表由机构办/科研处/医务处提交医院伦理委员会办公室ThisformshallbesubmittedbytheOrganizationOffice/ScientificResearchDivision/DepartmentofMedicalAdministrationtotheECofficeofthehospital.*对于跟踪审查项目，申办方及主要研究者信息若无更新则只需填写项目一般情况及药物临床试验机构审查意见。Foranytrackingreviewproject,itisonlynecessarytocompletegeneralinformationontheprojectandthereviewopinionoftheorganizationforclinicaltestofdrugsifthere’snoupdatingintheinformationontheapplicantandmaininvestigator.