CSR-009 最终监查报告

1、PerkinElmer*最终监查报告PerkinElmer*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 C

2、ompletion 其他 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:

3、ETHICS COMMITTEE 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:

4、样本信息登记表可接受/满足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

5、 collected批注：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 unus

6、ed investigational 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

7、受/满足Acceptable / 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

8、any批注：Comments: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/use

9、r manuals, Quality 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 com

10、pleted and original 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

11、 dated result 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 reco

12、rds arranged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 b

13、y sponsor所有剩余的器械已回收/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 int