这几年的稽查工作中，时常有人告诉我说研究者不让看电子病历系统/患者住院病历，因此我没查看这些文件，不过研究者都已经通过问诊把病史记录在V1了。但是通常情况是，一旦作为稽查员跟研究者说明原因：1．确认患者病史，用药史；2．确认患者是否合格3．ICHGCP1.21,4.9.7,5.15，6.10,合同，方案都约定了recordsaccessible
于是研究者就打开电脑让我看EMR了。而通常你就会吃惊的发现，那些在试验里声称没住过院的，在这里都有记录；那些声称treatmentnaive的病人，结果都用了12年胰岛素。所以，无论研究人员如何强势，我们都应该说明利害关系，让研究者给我们recordaccess.医院不允许监查员进入EMR查阅，可以要求研究者/研究护士打开EMR帮你搜索，你可以陪同查看。而完全依赖研究者在文件中记录“医院电子病历系统，该受试者没有住院记录”以为就此高枕无忧，那么风险其实已经埋下。
最后，给大家分享下FDA就我在澳洲某中心被拒绝查看patientrecords给出的回复，这篇文章已被ClinicalAdvisor发表，希望大家也能从中有所感悟。谢谢
CanFDAInspectorsAccessMedicalRecordswithoutConsent?
Accessrefused
Thequerydescribeshowanauditorrecentlyapproachedaninvestigatorinordertoperformastudyaudit.Theinvestigatorstatedthatalthoughhisresearchandprivatepracticeactivitiestookplaceinthesamebuilding,theywereseparatecorporateentities.Asaresult,hewouldnotallowtheauditoraccesstotheprivatepracticerecordsforsubjectsenteredintothestudy.HealsoindicatedthatauditorsandtheFDAdidnothavealegalrighttoseetheprivatepracticerecords,andthatneithercouldviewtherecordsbecausethesubjectswerepsychiatricpatients.HeaddedthathehadundergonefourpreviousFDAinspectionsandthattheagencyhadneveraskedtoseehisprivatepracticerecordsforsubjectsinclinicalstudies.
Theinvestigatortoldtheauditorthathehadcopied–fromhisprivatepractice–thoserecordsthathedeemedrelevanttosupporttheprimarydiagnosisforstudyentry,addingthattheserecordswereavailableintheresearchchartsforreview.However,hewouldnotprovidetheauditorwithcertifiedcopiesofanyofhisprivatepracticerecordsasthatwouldrepresentadoublestandard,onthebasisthathedoesnotrequirecertifiedcopiesofrecordsrequestedfromotherphysicians.
Theauditorfeltthatthelimitedcopiesmadeavailablebytheinvestigatorwouldnotnecessarilyprovidealltheinformationneeded(eg.aboutcon