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1、PerkinElmer*最终监查报告STUDY CLOSE OUT VISIT REPORT研究编号Study number最终拜访日期Date of close out visitdd/mm/yy研究名称Study title研究机构Study site研究者 Study Investigator(s)申办方监查员Monitor(s)Study sponsor personnel present研究机构人员Study site personnel present研究完成原因Reason for study completion正常研究结题 Normal Study Completion 其他
2、 Other:可接受/满足PROTOCOL AND STUDY CONDUCTAcceptable / Adequate是 Yes否 No不确定NA备注Comments遵从并执行与研究者审核过的临床方案Adherence to the study protocol reviewed with the investigator不良事件跟踪己完成Adverse events follow-up completed是否出现方案偏离Protocol deviation(s)是否有遗漏未解决的问题Any remaining unresolved issues批注Comments:ETHICS COMMI
3、TTEE AND REGULATORY AUTHORITIES可接受/满足Acceptable / Adequate是否不适用备注YesNoNAComments伦理委员会(研究结束告知书，临床研究报告，不良事件报告，如有)Ethics Committee (study completion notification, final study report, adverse events reporting as applicable)监管机构(上报如适用)Regulatory authority (reporting as applicable)批注：Comments:样本信息登记表可接受/满
4、足Acceptable / AdequateCASE REPORT FORMS是否不适用备注YesNoNAComments所有的样本信息登记表已完成All CRFs completedAll CRFs corrected and correction forms collected所有原始的样本信息登记表已收集All original CRFs collectedCRF archiving arranged (note to study binder, if separate location)所有未使用的研究物料已收集All unused study material collected批注
5、：Comments:研究产品/考核器械可接受 / 满足 Acceptable / AdequateSTUDY PRODUCT / INVESTIGATIONAL DEVICE是 Yes否 No不适用NA备注Comments考核器械的交接文件已完成Documentation of delivery and receipt of investigational device completed器械数量登记表和库存表已完成Device accountability log completed and inventory done所有未使用的考核器械已收集或销毁All unused investiga
6、tional devices collected/destroyed批注：Comments:仪器可接受/满足Acceptable / AdequateEQUIPMENTS是否不适用备注YesNoNAComments研究期间仪器使用登记表复印件已收集Instrument log books during study period, copies to be collected实验室水纯化系统Laboratory water purification system是否出现温度偏离Temperature deviations, if any批注：Comments:温度监控可接受/满足Acceptab
7、le / AdequateTEMPERATURE MONITORING是否不适用备注YesNoNAComments实验室设施的温度监控记录已复印并存档Temperature monitoring data from laboratory facilities, copies to be collected试剂和样本存储温度记录已复印并存档Temperature monitoring data from reagent and sample storage, copies to be collected是否出现温度偏离Temperature deviations, if any批注：Commen
8、ts:研究资料审核可接受/已更新Acceptable / Up-to-dateSTUDY BINDER REVIEW是Yes否No不适用NA备注Comments签字的临床方案及其修正案Signed study protocol and all its amendments伦理委员会批件/对应材料Ethics committee approval(s)/correspondence审查的知情同意书Informed consent forms checked考核器械说明书/用户手册，质控证书，材料安全数据表Investigational device inserts/user manuals, Q
9、uality Control Certificate(s), Material Safety Data Sheet(s)签字的临床协议Signed study agreement研究者简历CV of study site investigator完成的监查日志原件(研究者文件夹中留存复印件)Monitoring visit log completed and original collected (copy in study binder)完成的研究者授权及签名样张原件(研究者文件夹中留存复印件)Site signature and delegation log completed and o
10、riginal collected (copy in study binder)完成的器械数量登记表和运输文件原件(研究者文件夹中留存复印件)Device accountability log completed and original collected (copy in study binder) and shipping documentation仪器使用登记表(研究期间的复印件)Instruments logbooks (copies collected from study period)签署名字和日期的打印结果和/或电子结果和人口学数据Signed and dated resul
11、t printouts and/or electronic result files and demographic data样本信息登记表Completed case report forms相关文件Correspondence批注：Comments:存档可接受/满足Acceptable / AdequateARCHIVING是否不适用备注YesNoNAComments已存档Archiving arranged (note the study binder if separate location)电子记录已存档Archiving of electronic records arranged
12、原始数据在研究结束后将按照规定的时间留存Data storage agreed for appropriate retention period after study批注：Comments:研究结束拜访可接受/满足Acceptable / AdequateSTUDY CLOSE OUT是否不适用备注YesNoNAComments仪器已归还申办方或已按要求处理Return instruments to sponsor or as directed申办方提供的剩余样本已运回/销毁Ship/destroy any remaining specimens provided by sponsor所有剩
13、余的器械已回收/销毁All unused investigational devices collected/destroyed研究者行动 ACTIONS FOR STUDY SITE INVESTIGATOR申办方行动 ACTIONS FOR SPONSOR访视期间回收的文件 DOCUMENTS COLLECTED DURING VISIT研究机构结束拜访评估 EVALUATION OF CLOSING THE STUDY SITE是Yes否No不适用备注NA Comments研究结束且相关工作已充分完成Study s让e closed and all adequate activities performed批注:Comments:The document is approved for its intended use by:APPROVER NAMEROLEDATEInclude in the approval flow Author of the assessment and Reviewer of the assessment.Highlighted text (yellow) in this template are instructions.Delete them when not required anymore.