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1、临床试验启动会议纪要InitiationMeetingMinutesSubject:主题临床试验启动会Date:日期Venue:地点Participants:出席人员见会议签到表MeetingAttendanceRecordPreparedby:记录员下列文件在启动会时是否获得ListbelowalldocumentsthathavebeencollectedattheinitiationmeetingYesNo•临床试验批件ClinicalTrialPermission(fromSFDA)•伦理批件ECAppr
2、ovalLetter•合同Contract如“否”,请说明If“No”,pleasecomment:确认试验物品是否到达中心ConfirmationofstudymaterialsandsuppliesatsiteYesNo•研究者文件夹Investigator’StudyFile•试验基本文件Protocol,CRF,ICF,Sourcedocument,Subjectdiary•研究药物包括签收单Studydrug,includingreceipt•试验所需设备或材料StudySupplies/materia
3、ls•应急信件或盲底EmergencyEnvelopand/orRandomizationList如“否”,请说明If“No”,pleasecomment:会中讨论DiscussedintheMeetingYesNo1.受试者入组SubjectsRecruitment–本中心计划入组数SitePlannedSubjectRecruitmentNo.:–预期入组期限ExpectedRecruitmentDuration:如“否”,请说明If“No”,pleasecomment:2.研究程序StudyProcedur
4、e–研究时间StudyTimeline–研究方案SignedProtocolVersion/Date:–伦理批准的知情同意书ICFApprovedbyECVersion/Date:–病例报告表CRFVersion/Date:–原始病历SourcedocumentVersion/Date:–受试者日记SubjectDiaryVersion/Date:–受试者评估程序SubjectAssessmentProcedure–样本处理和保存BiologySampleHandlingandStorage–中心实验室程序Cen
5、tralLabProcedure(ifapplicable)–受试者退出SubjectWithdrawal–应急信封/随机程序EmergencyEnvelop/RandomizationProcedure如“否”,请说明If“No”,pleasecomment:1.药物管理StudyDrugManagement–药物储存DrugStorage–药物接收、发放和计数DrugReceipt,DispensingandAccountability–药物归还/销毁DrugReturn/Destruction–紧急破盲程序
6、EmergencyUnblindingProcedure如“否”,请说明If“No”,pleasecomment:2.安全性问题SafetyIssues–不良事件记录AdverseEventRecording–严重不良事件的记录、报告和跟踪SAERecording,ReportingandFollow-up–发生怀孕的报告程序ProceduresincaseofPregnancy如“否”,请说明If“No”,pleasecomment:3.数据记录DataRecording–CRF的填写和更改CRFComplet
7、ion&Correction–差异报告处理DiscrepancyReporthandling如“否”,请说明If“No”,pleasecomment:1.试验文档StudyDocuments–研究者文件夹以及存档Investigator’sStudyFile&Archiving如“否”,请说明If“No”,pleasecomment:2.任务分配及授权TaskAuthorization–完成方案签字页SignatureSheetforProtocol–完成任务授权表TaskAuthorizationFormTas
8、kAuthorizationForm如“否”,请说明If“No”,pleasecomment:启动会主要内容记录(请根据试验项目要求进行记录,可附页)附件:1、会议签到表2、方案签字页(研究者签名样张)3、任务授权表会议签到表MeetingAttendanceRecord方案号ProtocolNo.:方案名称StudyTitle:会议名称MeetingName:启动会会议