临床试验监查计划+监查报告+监查记录.pdfVIP

临床试验监查计划+监查报告+监查记录

XXX

XXXtrialparticipants。adherencetoapprovedprotocolsand

ns。andaccurateandcompletetrialrecordsandreports。XXX

clinicaltrial:

MonitoringleandContent:

1.Verifythattheclinicaltrialfacilityhasappropriatens。

includingqualifiedpersonnel。well-equippedlaboratories。

sufficientnumberofpotentialparticipants。XXX.

2.MonitorwhethertheclinicalXXX。standards。andXXX.

3.XXXbeforeparticipatingintheclinicaltrial(exceptfor

casesofwaivedconsent)。andXXXprocessandtrialprogress。

Recordanyfollow-up。tests。orXXX.

4.XXXandconsistentwithoriginaldata。Correctorannotate

anyerrorsorns。andhavetheresearcherssignanddatethem。

Confirmandrecordthenumberofcases。gender。age。and

treatmenteffect(ifany)foreachtrial.

5.RecordanycasesofXXX。anddiscusswiththe

researchers.

6.Recordalladverseevents。ns。andotherdevicedefects。

andreportXXX.

7.Monitorthesupply。use。maintenance。XXX。n。

storage。n。handling。andrecoveryoftrialmedicaldevice

samples.

8.SuperviseXXX.

9.XXX.

ComprehensiveMonitoring:

Monitoringworkdocuments:

1.Clinicaltrialnstage

2.Clinicaltrialnstage

3.XXX

Monitoringreport(templateinAppendix1)andmonitoring

record(templateinAppendix2)XXXwork.

Appendix1:XXX

ProjectName:

XXXUnitName:

XXX:

Monitor:

MonitoringStage:□nStage□XXX

XXX):

XXX

XXX

XXX

6.CaseReportFormsandOriginalData

Other

ParticipantnStatus(cumulative):

Numberofretrospectivesamplesincluded

Follow-upofusmonitoringfindings:

Issues:

Summary:

MonitorsSignature:

Date:

Appendix2:MonitoringRecord

MonitoringStage:□nStage□XXX

MonitoringContent:

MonitoringResults:

nsXXX:

MonitorsSignature:

Date:

这篇文章似乎是一份调查表格，但是由于格式问题，很难

理解其意义。因此，我会尝试重新组织它并进行