SOP-MS-06-F-01-附件1-临床试验总结报告核查清单

临床试验总结报告核查清单Clinical Study Report QC Checklist方案号Protocol No.:总结报告版本日期CSR Version/Date讨论题目Study Title:起草人Drafted by:内容Items审核团队Review team*是否符合要求？Whether meet the requirements?PMSADM是Yes不适用/否，请备注NA/No, provide comments1版本Version1.1版本号和日期Version and date (Version _ / date )X2首页Title Page2.1 . 讨论题目Study titleX2.2方案编号Protocol numberX2.3试验起始/完成日期Date of enrollment/completedX2.4申办方信息Sponsor informationX2.5主要讨论者和讨论中心Principal investigator and study siteX2.6统计学负责人和统计单位Statistician and statistical siteX2.7报告日期Report dateX2.8原始资料保存地点Source data storageX3摘要SynopsisX3.1讨论药物名称Name of study drugX内容Items审核团队Review team*是否符合要求？Whether meet the requirements?PMSADM是Yes不适用/否，请备注NA/No, provide comments3.2文献发表PublicationX3.3讨论主要目的Primary objective(s)X3.4讨论次要目的Secondary objective(s)X3.5讨论方法MethodologyX3.6受试者人数（原计划和参加分析的）Numbers of patients (planned and analyzed)X3.7病例选择（入选标准、排除标准）Selection of subjects (inclusion criteria, exclusion criteria)X3.8讨论药物信息（剂量，批号，用法用量）Study drug(s) information (dose, batch number, mode of administration)X3.9主要疗效终点Primary efficacy endpointX3.10次要疗效终点Secondary efficacy endpoint(s)X3.11安全性分析Safety evaluationX3.12统计方法Statistical methodsX3.13讨论概况Study summaryX3.14讨论结论Study conclusionX3.15报告日期Date of reportX4基本资料Basic Information4.1机构审核委员或伦理委员会Institutional review board or ethics committeeX4.2讨论的伦理Ethical conduct of the studyX4.3知情同意Informed consentX4.4讨论中心和讨论者名单Study sites and investigator listX4.5监查单位Monitoring unitX内容Items审核团队Review team*是否符合要求？Whether meet the requirements?PMSADM是Yes不适用/否，请备注NA/No, provide comments4.6数据管理单位Data management unitX4.7...