CSR-009 最終監(jiān)查報告

1、PerkinElmer*最終監(jiān)查報告PerkinElmer*STUDY CLOSE OUT VISIT REPORT研究編號Study number最終拜訪日期Date of close out visitdd/mm/yy研究名稱Study title研究機(jī)構(gòu)Study site研究者 Study Investigator(s)申辦方監(jiān)查員Monitor(s)Study sponsor personnel present研究機(jī)構(gòu)人員Study site personnel present研究完成原因Reason for study completion正常研究結(jié)題 Normal Study C

2、ompletion 其他 Other:可接受/滿足PROTOCOL AND STUDY CONDUCTAcceptable / Adequate是 Yes否 No不確定NA備注Comments遵從并執(zhí)行與研究者審核過的臨床方案Adherence to the study protocol reviewed with the investigator不良事件跟蹤己完成Adverse events follow-up completed是否出現(xiàn)方案偏離Protocol deviation(s)是否有遺漏未解決的問題Any remaining unresolved issues批注Comments:

3、ETHICS COMMITTEE AND REGULATORY AUTHORITIES可接受/滿足Acceptable / Adequate是否不適用備注YesNoNAComments倫理委員會(研究結(jié)束告知書，臨床研究報告，不良事件報告，如有)Ethics Committee (study completion notification, final study report, adverse events reporting as applicable)監(jiān)管機(jī)構(gòu)(上報如適用)Regulatory authority (reporting as applicable)批注：Comments:

4、樣本信息登記表可接受/滿足Acceptable / AdequateCASE REPORT FORMS是否不適用備注YesNoNAComments所有的樣本信息登記表已完成All CRFs completedAll CRFs corrected and correction forms collected所有原始的樣本信息登記表已收集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:研究產(chǎn)品/考核器械可接受 / 滿足 Acceptable / AdequateSTUDY PRODUCT / INVESTIGATIONAL DEVICE是 Yes否 No不適用NA備注Comments考核器械的交接文件已完成Documentation of delivery and receipt of investigational device completed器械數(shù)量登記表和庫存表已完成Device accountability log completed and inventory done所有未使用的考核器械已收集或銷毀All unus

6、ed investigational devices collected/destroyed批注：Comments:儀器可接受/滿足Acceptable / AdequateEQUIPMENTS是否不適用備注YesNoNAComments研究期間儀器使用登記表復(fù)印件已收集Instrument log books during study period, copies to be collected實驗室水純化系統(tǒng)Laboratory water purification system是否出現(xiàn)溫度偏離Temperature deviations, if any批注：Comments:溫度監(jiān)控可接

7、受/滿足Acceptable / AdequateTEMPERATURE MONITORING是否不適用備注YesNoNAComments實驗室設(shè)施的溫度監(jiān)控記錄已復(fù)印并存檔Temperature monitoring data from laboratory facilities, copies to be collected試劑和樣本存儲溫度記錄已復(fù)印并存檔Temperature monitoring data from reagent and sample storage, copies to be collected是否出現(xiàn)溫度偏離Temperature deviations, if

8、any批注：Comments:研究資料審核可接受/已更新Acceptable / Up-to-dateSTUDY BINDER REVIEW是Yes否No不適用NA備注Comments簽字的臨床方案及其修正案Signed study protocol and all its amendments倫理委員會批件/對應(yīng)材料Ethics committee approval(s)/correspondence審查的知情同意書Informed consent forms checked考核器械說明書/用戶手冊，質(zhì)控證書，材料安全數(shù)據(jù)表Investigational device inserts/use

9、r manuals, Quality Control Certificate(s), Material Safety Data Sheet(s)簽字的臨床協(xié)議Signed study agreement研究者簡歷CV of study site investigator完成的監(jiān)查日志原件(研究者文件夾中留存復(fù)印件)Monitoring visit log completed and original collected (copy in study binder)完成的研究者授權(quán)及簽名樣張原件(研究者文件夾中留存復(fù)印件)Site signature and delegation log com

10、pleted and original collected (copy in study binder)完成的器械數(shù)量登記表和運(yùn)輸文件原件(研究者文件夾中留存復(fù)印件)Device accountability log completed and original collected (copy in study binder) and shipping documentation儀器使用登記表(研究期間的復(fù)印件)Instruments logbooks (copies collected from study period)簽署名字和日期的打印結(jié)果和/或電子結(jié)果和人口學(xué)數(shù)據(jù)Signed and

11、 dated result printouts and/or electronic result files and demographic data樣本信息登記表Completed case report forms相關(guān)文件Correspondence批注：Comments:存檔可接受/滿足Acceptable / AdequateARCHIVING是否不適用備注YesNoNAComments已存檔Archiving arranged (note the study binder if separate location)電子記錄已存檔Archiving of electronic reco

12、rds arranged原始數(shù)據(jù)在研究結(jié)束后將按照規(guī)定的時間留存Data storage agreed for appropriate retention period after study批注：Comments:研究結(jié)束拜訪可接受/滿足Acceptable / AdequateSTUDY CLOSE OUT是否不適用備注YesNoNAComments儀器已歸還申辦方或已按要求處理Return instruments to sponsor or as directed申辦方提供的剩余樣本已運(yùn)回/銷毀Ship/destroy any remaining specimens provided b

13、y sponsor所有剩余的器械已回收/銷毀All unused investigational devices collected/destroyed研究者行動 ACTIONS FOR STUDY SITE INVESTIGATOR申辦方行動 ACTIONS FOR SPONSOR訪視期間回收的文件 DOCUMENTS COLLECTED DURING VISIT研究機(jī)構(gòu)結(jié)束拜訪評估 EVALUATION OF CLOSING THE STUDY SITE是Yes否研究者行動 ACTIONS FOR STUDY SITE INVESTIGATOR申辦方行動 ACTIONS FOR SPONSOR訪視期間回收的文件 DOCUMENTS COLLECTED DURING VISIT研究機(jī)構(gòu)結(jié)束拜訪評估 EVALUATION OF CLOSING THE STUDY SITE是Yes否No不適用備注NA Comments研究結(jié)束且相關(guān)工作已充分完成Study s讓e closed and all adequate activities performed批注:Comments:The document is approved for its int