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["临床试验资料归档目录"]
[]
["项目名称："]
["中心名称",null,"中心编号"]
["申办者"]
["立项时间",null,"合同签署时间"]
["首例入组 时间",null,"最后一例出组   时间"]
["序号","文件名称","文件形式","备 注"]
[1,"NMPA《药物临床试验批件》/受理通知书","复印件盖章"]
[2,"人类遗传办批件/通知书及相关申请材料或（不涉及人类遗传资源审批或备案的声明）","复印件盖章"]
[3,"组长单位/本中心伦理委员会批件","复印件盖章"]
[4,"徐州市肿瘤医院临床试验立项审批表","复印件"]
[5,"药品监督管理部门对临床试验方案、临床试验方案修改及其它文件的许可、备案","复印件盖章"]
[6,"原始资料确认表（签字）","原件签字盖章"]
[7,"申办方资料真实性说明","原件盖章"]
[8,"申办方资质证明（营业执照，药品生产许可证或无生产许可证声明）及更新资质证明","复印件盖章"]
[9,"试验药品与对照药品GMP证书或GMP符合性声明（委托生产需提供药品生产委托书及资质证明）","复印件盖章"]
[10,"参研中心名单","原件盖章"]
[11,"申办方对分中心的委托函","原件盖章"]
[12,"主要研究者承诺书","原件签字"]
[13,"保密协议","原件盖章"]
[14,"CRO资质证明及委托函","复印件盖章"]
[15,"CRA授权委托函及资质证明材料（简历、GCP证书、身份证复印件）","复印件盖章"]
[16,"监查责任表（若适用）","复印件盖章"]
[17,"临床试验合同（包括主协议、补充协议、CRC协议）","复印件"]
[18,"病例数变更申请表（若适用）","原件盖章"]
[19,"试验方案及其修订版（包括变更说明，签字页）","原件盖章","注明版本号、版本日期"]
[20,"方案摘要及其修订版","文本盖章","注明版本号、版本日期"]
[21,"研究者手册及其修订版","文本盖章","注明版本号、版本日期"]
[22,"知情同意书及其修正案版本及相关文件","文本盖章","注明版本号、版本日期"]
[23,"病例报告表（CRF）及其修订版","文本盖章","注明版本号、版本日期"]
[24,"研究病历/受试者日记卡及其修订版本","文本盖章","注明版本号、版本日期"]
[25,"受试者招募广告及其他提供给受试者的书面文件","文本盖章","注明版本号、版本日期"]
[26,"受试者保险及修订版本相关文件","复印件盖章"]
[27,"伦理委员会对更新文件的书面审查意见","复印件盖章"]
[28,"原始医疗文件（如受试者门诊病历、住院病历、生命体征表、化验报告等检查报告）","原件","受试者文件（每个受试者的文件按照筛选、入组的时间顺序，将病历整理好， 命名为患者的筛选号），每份材料顺序保持一致"]
[29,"已签字的研究病历/日记卡","原件"]
[30,"已签署研究者姓名、记录日期和填写完整的病例报告表（CRF）及病例报告表修改记录","原件"]
[31,"已签字的知情同意书","原件"]
[32,"已签字的电话随访记录表","原件"]
[33,"受试者访视材料","原件"]
[34,"受试者相关记录表(筛选入选表、鉴认代码表、退出记录表）","原件"]
[35,"完成试验受试者编码目录","原件"]
[36,"团队成员名单（所有研究者签字、可用分工授权表代替）","复印件盖章"]
[37,"研究者简历、资格证明文件、GCP证书及更新件","原件"]
[38,"研究者签名样张及授权分工表/更新件","原件"]
[39,"研究中心启动会相关培训材料","复印件"]
[40,"培训记录-监查员或项目团队成员对研究人员的培训（如量表的培训、日常监查后发现问题的培训等）","原件"]
[41,"EDC培训记录/电子签名声明","原件"]
[42,"所有试验相关会议纪要（若适用）","原件"]
[43,"本中心SAE相关材料（包含报告表、递交函、SAE 汇总表、SAE 报告表（首次报告及跟踪报告）、SAE 伦理备案及回执（本中心/负责单位EC）","原件","注明受试者的筛选号及首次（跟踪、总结）报告，并注明时间。SUSAR或进展报告在此项下，注明名称、日期"]
[44,"受试者方案违背/偏离报告（原件）","原件"]
[45,"研究者致申办者的严重不良事件报告","原件"]
[46,"研究终止/中断报告或终止报告（若适用）","原件"]
[47,"申办者和/或研究者致药品监督管理部门、伦理委员会的严重不良事件及其它安全性信息报告（若适用）","原件"]
[48,"申办者致研究者的安全性信息通告","原件"]
[49,"中期或年度报告","原件"]
[50,"设盲试验的破盲程序（若适用）","复印件盖章"]
[51,"破盲证明（若适用）","原件"]
[52,"总随机表（若适用）","原件"]
[53,"药品管理及操作指南","复印件盖章"]
[54,"试验用药品的检验报告/已上市药品说明书（含试验药、对照药、基础药物）及涉及批号的更新件","复印件盖章"]
[55,"临床试验用药物标签","原件盖章"]
[56,"试验用药品专用处方","原件"]
[57,"试验用药品登记表","原件"]
[58,"试验用药品保管文件（包括试验药品发放回收记录表、储存温湿度记录表、药品退回记录表（退回至申办方）、试验用药品销毁证明等材料）","原件"]
[59,"试验用药品转移申请函","原件盖章"]
[60,"试验用药品及试验相关物资转运交接单（包含快递运输记录）","原件"]
[61,"生物样本管理指南","复印件盖章","注明版本号、版本日期"]
[62,"生物样本采集、处理、使用、保存、运输、交接、销毁等各环节的完整记录（可溯源）","原件"]
[63,"所有检测试验结果原始记录（若适用）","原件"]
[64,"在试验方案中涉及的医学、实验室、专业技术操作和相关检测的正常值范围、使用仪器、设备生产厂家、型号及相关更新件","复印件盖章"]
[65,"临床试验中有关检查项目实验室质控证明及更新件","复印件盖章"]
[66,"试验相关仪器设备合格证或校准证明","复印件盖章"]
[67,"监查员计划、访视记录/监查报告","原件"]
[68,"试验相关文件资料销毁记录（若适用）","原件","注明销毁材料名称、销毁时间、销毁方式，并签字"]
[69,"数据疑问表（研究者签字）（若适用）","原件"]
[70,"关闭中心/停止入组函","原件盖章"]
[71,"研究者向伦理委员会提交的试验完成文件","原件"]
[72,"分中心临床试验小结表","原件"]
[73,"临床试验总结报告","原件盖章"]
[74,"其他（若有其它材料，自行添加）"]
[null,"血糖仪发放表格","（若适用）","此部分内容若适用，请自行将材料归至相关目录下"]
[null,"试验用药品配制、使用的标准操作规程","（若适用）"]
[null,"试验用药品配制记录表","（若适用）"]
[null,"血样离心/分装记录表","（若适用）"]
[null,"尿样收集/处理记录表","（若适用）"]
[null,"血样入库/出库（冻存）记录表","（若适用）"]
["备注：                                                                                                               1、“其他”中各项文件：如有，请归档；如无，则不适用。                                                                  2、如有目录中未明确文件归档，请追加在“其他”。"]