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1、ReferencenumberISO14155:2011(E)?ISO2011INTERNATIONALSTARDISO14155Secondedition20110201Clinicalinvestigationofmedicaldevicesfhumansubjects—GoodclinicalpracticeInvestigationcliniquedesdispositifsmdicauxpoursujetshumains—Bo
2、nnespratiquescliniquesCopyrightInternationalganizationfStardizationProvidedbyIHSunderlicensewithISONotfResaleNoreproductionwkingpermittedwithoutlicensefromIHS``````````````ISO14155:2011(E)?ISO2011–AllrightsreservediiiCon
3、tentsPageFewd.............................................................................................................................................................v1Scope...........................................
4、...........................................................................................................12Nmativereferences..............................................................................................
5、..............................13Termsdefinitions...........................................................................................................................24Ethicalconsiderations..........................
6、................................................................................................74.1General.................................................................................................................
7、..................................74.2Improperinfluenceinducement......................................................................................................84.3Compensationadditionalhealthcare.................
8、.........................................................................84.4Responsibilities...............................................................................................................................
9、......84.5Communicationwiththeethicscommittee(EC)................................................................................84.5.1General..............................................................................
10、.....................................................................84.5.2InitialECsubmission............................................................................................................................84
11、.5.3InfmationtobeobtainedfromtheEC..............................................................................................94.5.4ContinuingcommunicationwiththeEC......................................................
12、.......................................94.5.5ContinuinginfmationtobeobtainedfromtheEC.........................................................................94.6Vulnerablepopulations.....................................
13、....................................................................................94.7Infmedconsent.......................................................................................................................
14、.........104.7.1General.................................................................................................................................................104.7.2Processofobtaininginfmedconsent..............
15、..............................................................................104.7.3Specialcircumstancesfinfmedconsent..................................................................................104.7.4Infmationtob
16、eprovidedtothesubject........................................................................................114.7.5Infmedconsentsignature..................................................................................
17、.............................134.7.6Newinfmation..................................................................................................................................135Clinicalinvestigationplanning..........
18、................................................................................................145.1General................................................................................................................
19、.................................145.2Riskevaluation....................................................................................................................................145.3Justificationfthedesignofthecli
20、nicalinvestigation.................................................................145.4Clinicalinvestigationplan(CIP)......................................................................................................
21、...145.5Investigatsbrochure(IB)................................................................................................................155.6Casereptfms(CRFs).......................................................
22、............................................................155.7Monitingplan....................................................................................................................................155.8Invest
23、igationsiteion................................................................................................................155.9Agreement(s).............................................................................
24、..........................................................155.10Labelling...............................................................................................................................................155.
25、11Datamonitingcommittee(DMC)....................................................................................................166Clinicalinvestigationconduct.............................................................
26、..............................................166.1General.................................................................................................................................................166.2Investigatio
27、nsiteinitiation.................................................................................................................166.3Investigationsitemoniting..............................................................
28、...............................................166.4Adverseeventsdevicedeficiencies...........................................................................................166.4.1Adverseevents..........................
29、..........................................................................................................166.4.2Devicedeficiencies.........................................................................................
30、....................................166.5Clinicalinvestigationdocumentsdocumentation....................................................................176.5.1Amendments...................................................
31、.....................................................................................176.5.2Subjectidentificationlog........................................................................................................
32、............176.5.3Sourcedocuments..............................................................................................................................176.6Additionalmembersoftheinvestigationsiteteam............
33、.............................................................176.7Subjectprivacyconfidentialityofdata......................................................................................176.8Documentdatacontrol.........
34、.......................................................................................................18CopyrightInternationalganizationfStardizationProvidedbyIHSunderlicensewithISONotfResaleNoreproductionwkingpermitted
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