(英文版)医疗器械临床试验质量管理规范

1、专业医疗器械咨询维康嘉业专业医疗器械咨询维康嘉业网址：由0箱：FG-20160601025GoodClinicalPracticeforMedicalDevices(No.25OrderofCFDAandNHFPC)OrderofChinaFoodandDrugAdministrationandNationalHealthandFamilyPlanningCommissionofChinaNo.25AdoptedatthemeetingofCFDAandNHFPC,thispracticeisherebypromulgated,andshalltakeeffectasofJune1,2016.

2、DirectorBiJingquanDirectorLiBinMarch1,2016GoodClinicalPracticeforMedicalDevicesChapter1GeneralprovisionsArticle1ThePracticeisformulatedinaccordancewiththeRegulationsontheSupervisionandAdministrationofMedicalDevicesinordertofurtherstrengthenthemanagementofclinicaltrialsofmedicaldevices,protecttherigh

3、tsandbenefitsoftrialsubjectsandassuretheclinicaltrialprocedurestandard,truthful,scientific,reliableandtraceable.Article2AlltheclinicaltrialsofmedicaldeviceswithintheterritoryofthePeoplesRepublicofChinashallbeconductedaccordingtothepractice.ThePracticecoversthewholeprocedureofclinicaltrialofmedicalde

4、vices,includingtheprotocoldesign,conduction,monitoring,audit,inspection,collectionofdata,record,analysisandsummaryandreportofclinicaltrial,etc.Article3ClinicaltrialofmedicaldevicesmentionedinthisPracticereferstotheprocessofconfirmingandverifyingthesafetyandefficacyofthemedicaldeviceintendedtoapplyre

5、gistrationundernormalconditioninqualifiedclinicaltrialinstitutionsofmedicaldevices.Article4Clinicaltrialsofmedicaldevicesshallcomplywiththeprincipleoflegal,ethicandscience.Article5Foodanddrugregulatoryauthorityaboveprovincelevelareresponsibleforthesupervisionandmanagementofclinicaltrailsofmedicaldev

6、ices.ThecompetentdepartmentofNationalHealthandFamilyPlanningCommissionshallstrengthenthemanagementofclinicaltrailsofmedicaldeviceswithinthescopeofitsduties.FoodanddrugregulatoryauthorityandthecompetentdepartmentofNHFPCshallestablishtheinformationnotificationsystemonqualitymanagementofmedicaldevicecl

7、inicaltrialsandstrengthentheinformationnotificationonthe专业医疗器械咨询维康嘉业网址： HYPERLINK 由0箱：专业医疗器械咨询维康嘉业专业医疗器械咨询维康嘉业网址：由0箱：approvalforconductingclinicaltrialofClassIIImedicaldevicesandthemedicaldeviceslistedinthemanagementcatalogoflargemedicalequipmentcollocationinChinaandthedataofthesupervisionandmanagem

8、entonrelevantclinicaltrial.ChapterIIPreparationbeforeclinicaltrialsArticle6Thereshouldbesufficientscientificbasisandcleartrialpurposetoconductclinicaltrialsofmedicaldevices,andtheexpectedbenefitsandriskstothehealthofsubjectsandpublicshallbeweighed,theexpectedbenefitsshouldexceedthepossibledamage.Art

9、icle7Beforeclinicaltrial,thesponsorshallcompletethepre-clinicalstudyofinvestigationalmedicaldevices,includingthedesignofproducts(structureandcomposition,workingprincipleandmechanismofaction,intendeduse,applicationscopeandapplicabletechnicalrequirements)andqualityinspection,animaltrialandanalysisrepo

10、rt,etc,andtheresultsshallsupporttheclinicaltrial.Theresultsofqualityinspectionincludereportofself-inspectionandthequalifiedreportforregistrationinspectionissuedbyaqualifiedinspectionagencywithinoneyear.Article8Beforeclinicaltrial,thesponsorshallprepareadequateinvestigationalmedicaldevices.Thedevelop

11、mentofinvestigationalmedicaldevicesshallmeetrelevantrequirementsofqualitymanagementsystemofmedicaldevices.Article9Clinicaltrialsofmedicaldevicesshallbeconductedintwoormorethantwoclinicaltrialinstitutionsofmedicaldevices.Theselectedtrailinstitutionshallbequalifiedclinicaltrialinstitutionofmedicaldevi

12、cesandthefacilitiesandconditionsshallmeettherequirementsforconductingclinicaltrialssafelyandeffectively.Theinvestigatorshouldhavetheprofessionalexpertise,qualificationsandabilitytoundertaketheclinicaltrialandshouldhavebeentrained.Administrativemeasuresforthequalificationrecognitionofclinicaltrialins

13、titutionsofmedicaldevicesshallbeformulatedseparatelybyChinaFoodandDrugAdministrationandNationalHealthandFamilyPlanningCommissionofChina.Article10Beforeclinicaltrial,thesponsor,clinicaltrialinstitutionandinvestigatorshallmakeawrittenagreementontrialdesign,qualitycontroloftrial,divisionofresponsibilit

14、iesinthetrial,thecostofclinicaltrialsundertakenbythesponsorandthetreatmentprincipleofinjuriesthatmayoccurinthetrial.Article11Clinicaltrialsshouldbeapprovedbyethicscommitteeofclinicaltrialinstitutions.MedicaldeviceslistedinthedirectoryofClassIIImedicaldeviceclinicaltrialshallalsobeapprovedbyCFDA.Arti

15、cle12Beforeclinicaltrial,thesponsorshouldfiletolocalfoodanddrugregulatoryauthorityoftheprovince,theautonomousregionorthemunicipalitydirectlyundertheCentralGovernment.Thefoodanddrugregulatoryauthorityacceptingthefillingshouldreportthefilingsituationstothefoodanddrugregulatoryauthorityandthecompetenta

16、uthorityofNHFPCinthesamelevelwheretheclinicaltrialinstitutionislocated.ChapterIIIProtectionofrightsandbenefitsoftrialsubjectsArticle13ClinicaltrialsofmedicaldevicesshouldbeconductedinaccordancewiththeethicalprinciplesinWorldMedicalAssociationDeclarationofHelsinki.Article14Ethicalreviewandinformedcon

17、sentarethemainmeasurestoprotecttherightsandbenefitsofsubjects.Eachpartyinvolvedintheclinicaltrialshallundertakecorrespondingethicalresponsibilitiesaccordingtotheirdutiesinthetrial.Article15Thesponsorshouldavoidtocauseundueinfluenceormisleadingtosubjects,clinicaltrialinstitutionsandtheinvestigatorand

18、otherclinicaltrialparticipantsorrelatedparties.Clinicaltrialinstitutionandtheinvestigatorshouldavoidtocauseundueinfluenceandmisleadingtosubjects,thesponsorandotherclinicaltrialparticipantsorrelatedparties.Article16Thesponsor,clinicaltrialinstitutionandtheinvestigatorshallnotexaggeratethecompensation

19、measuresforparticipatinginclinicaltrialsandmisleadthesubjectstoparticipateinclinicaltrials.Article17Beforeclinicaltrial,thesponsorshallsubmitthefollowingdocumentstoethicscommitteethroughtheinvestigatorandthemanagementdepartmentofmedicaldeviceclinicaltrialofclinicaltrialinstitution:Protocolofclinical

20、trial;Investigatorsbrochure;Textofinformedconsentformandanyotherwrittendocumentsprovidedtosubjects;Proceduraldocumentsforrecruitingsubjectsandpublicity;Textofcasereportform;Self-inspectionreportandtheinspectionreportforproductregistration;Resumes,professionalexpertise,ability,trainingoftheinvestigat

21、orandotherdocumentstoprovequalifications;Overviewofthefacilitiesandconditionsofclinicaltrialinstitutionmeetingtrial;Declarationthatthedevelopmentofinvestigationalmedicaldevicesmeetrelevantrequirementsofapplicablequalitymanagementsystemofmedicaldevices;Otherdocumentsrelatedtoethicalreview.Ethicscommi

22、tteeshouldupholdtheprinciplesofethicsandscience,reviewandsupervisetheimplementationofclinicaltrials.Article18Ifoneofthefollowingcasesoccurduringtheclinicaltrial,theinvestigatorshallreportintimetothemanagementdepartmentofmedicaldeviceclinicaltrialofclinicaltrialinstitution,informthesponsorandreportth

23、eethicscommitteethroughthemanagementdepartment:Seriousadverseevents;Reportofprogress,includingsummaryforsafetyandreportofdeviation;Foranyrevisefortheapproveddocumentsbyethicscommittee,thenonsubstantivechangesthatdonotaffecttherightsandbenefits,safetyandhealthofsubjectsorisnotrelatedtothepurposeorend

24、pointofclinicaltrialdontneedtobereportedinadvance,butshallbenotifiedinwrittenformafterwards.Suspension,terminationorrequiringforrestoringtheclinicaltrialaftersuspension;deviationofclinicaltrialprotocolaffectingtherightsandbenefits,safetyandhealthofsubjectsorthescientificnature.Inordertoprotecttherig

25、htsandbenefits,safetyandhealthofsubjects,thedeviationinanemergencythatcantbereportedintimeshallbereportedassoonaspossibleinwrittenformafterwardsaccordingtorelevantprovisions.Article19Intheprocessofclinicaltrial,inthecastthatrevisingtheclinicaltrialprotocol,informedconsentformandotherdocuments,requir

26、ingfordeviationandrestoringthesuspendedclinicaltrial,thetrialshallcontinuetobeimplementedafterbeingapprovedbytheethicscommittee.Article20Theminors,pregnantwomen,oldpeople,personswithmentaldisability,patientsindangerandothersshallbeavoidedtobechosenassubjects;iftheyareneededtobechosenforsomenecessary

27、reason,relevantadditionalrequirementsprovidedbytheethicscommitteeshallbecomplied专业医疗器械咨询维康嘉业网址： HYPERLINK 由0箱：专业医疗器械咨询维康嘉业专业医疗器械咨询维康嘉业网址：由0箱：with,andthespecialdesignshallbeconductedfortheirhealthconditionsintheclinicaltrialanditshallbehelpfultotheirhealth.Article21Beforethesubjectsparticipatinginthe

28、clinicaltrial,theinvestigatorshallexplainthedetailsofclinicaltrialtothesubjects,theguardiansofpersonswithoutorwithlimitedcapacityforcivilconduct,includingrecognized,foreseeablerisksandpossibleadverseevents,etc.Thesubjectsandguardiansshallsigntheirnameandthedateontheinformedconsentformaftersufficient

29、anddetainedexplanation,andtheinvestigatorshallalsoneedtosignhisnameandthedate.Article22Thefollowingcontentsandexplanationsoftheitemsshallbeincludedintheinformedconsentform:Nameoftheinvestigatorandrelevantinformation;Nameofclinicaltrialinstitution;Name,purpose,methodandcontentsofthetrial;Processandth

30、etermofvalidityofthetrial;Sourcesoffundingforthetrialandpossibleconflictofinterest;Expectedpossiblebenefitsforsubjects,recognizedandforeseeablerisksandpossibleadverseevents;Alternativemethodofdiagnosisandtreatmentthatsubjectscanobtainandthepotentialbenefitsandrisks;Differentgroupswhichthesubjectswil

31、lbeassignedtointhetrialshallbeexplained,ifrequired;Thesubjectsshallbevoluntarytoparticipateinthetrialandhavetherighttowithdrawatanystageofthetrialwithoutdiscriminationorretaliation,andtheirmedicaltreatment,rightsandinterestsarenotaffected;Thepersonneldatathatthesubjectsareinformedtoparticipateinthet

32、rialisconfidential,buttheethicscommittee,foodanddrugregulatoryauthority,thecompetentauthorityofNHFPCorthesponsorcanlookupthepersonneldataintheneedtoworkaccordingtotheprescribedprocedures;Incaseofinjuryrelatedtothetrial,thesubjectsshallreceivetreatmentandeconomiccompensation;Thesubjectsshallknowthein

33、formationrelatedtothematanytimeduringthetrial;Freeitemsfordiagnosisandtreatmentandotherrelatedsupportthatsubjectsmayobtainduringthetrial.Thelanguageandwordsthatthesubjectsorguardianscanunderstandshouldbeusedfortheinformedconsentform.Theinformedconsentformshallnotcontainanycontentsthatwillcausethesub

34、jectstogiveuptheirlegalrightsandinterestsandwillexemptfromtheresponsibilitiesofclinicaltrialinstitutionsandtheinvestigator,thesponsorortheagent.Article23Thefollowingrequirementsshallbemettoobtaintheinformedconsent:Thedisabledsubjectscanalsoparticipateinclinicaltrialiftheethicscommitteeagreeinprincip

35、leandtheinvestigatorconsidersthatparticipatinginthetrialcanmeetthesubjectsinterests,buttheguardianofthesubjectshouldsignhisnameandnotethedatebeforethetrial;Ifboththesubjectandtheguardianhavenoreadingability,thereshouldbeawitnessonthespotduringtheinformedprocess.Afterbeingexplainedtheinformedconsentf

36、ormindetailandreadingitwhichisthesamewiththeoralinformedconsentandgettingtheoralagreementfromthesubjectorguardian,thewitnesscansignontheinformedconsentandnotethedate,thesignofthewitnessandtheinvestigatorshouldbeonthesameday.Whenaminoristakenasasubject,theinformedconsentoftheguardianshallbeobtainedan

37、dtheinformedconsentformshallbesigned.Iftheminorcanmakeanintentionwhethertoparticipateinthetrialornot,theconsentofhisownshallalsobeaskedfor.Ifimportantinformationorunexpectedclinicaleffectrelatedtotheinvestigationalmedicaldevicesarefound,relevantcontentsoftheinformedconsentformshallbemodified,themodi

38、fiedinformedconsentformshouldbere-signedforconfirmationbysubjectsorguardiansafterbeingapprovedbytheethicscommittee.Article24Thedateofformulationorthedateoftherevisedversionshallbeindicatedintheinformedconsentform.Iftheinformedconsentformisrevisedduringthetrial,therevisedinformedconsentformneedtobeap

39、provedbytheethicscommitteebeforeimplementation.Aftertherevisedinformedconsentformissubmittedtotheclinicaltrialinstitution,anewinformedconsentformshallbesignedifthesubjectsofalltheunfinishedtrialareaffected.Article25Thesubjectshavetherighttowithdrawfromanystageofclinicaltrialsandarenotliableforanyeco

40、nomicresponsibility.ChapterIVProtocolofclinicaltrialsArticle26Whenconductingclinicaltrialsofmedicaldevices,thesponsorshouldorganizetoformulatescientificandreasonableclinicaltrialprotocolaccordingtotheclassification,risksandintendeduseofinvestigationalmedicaldevices.Article27Forthenewproductsthathave

41、notapprovedtomarketinChinaorabroad,thesafetyandperformancehavenotconfirmedbymedical,thefeasibilitytestoflittlesampleshouldbecarriedoutfirstbeforeclinicaltrialprotocolisdesigned.Thenthesamplesizeshallbedeterminedaccordingtostatisticalrequirementsandthefollow-upclinicaltrialsshallbecarriedoutafterthes

42、afetyisinitiallyconfirmed.Article28Theclinicaltrialprotocolofmedicaldevicesshouldcontainthefollowingcontents:Generalinformation;Backgrounddataforclinicaltrials;Purposeforclinicaltrials;Designofclinicaltrials;Evaluationmethodforsafety;Evaluationmethodforefficacy;Considerationforstatistics;Provisionsf

43、orrevisingclinicaltrialprotocol;Provisionsforadverseeventsandreportofdevicedefect;Directaccesstosourcedataanddocuments;Ethicalissuesrelatedtoclinicaltrialsandthedescriptionandthetextofinformedconsentform;Datahandlingandrecordkeeping;Financingandinsurance;Agreementoftrialresultspublishing.Partoftheab

44、ovecontentscanbeincludedinotherrelevantdocumentationsoftheprotocolsuchasinvestigatorsbrochure.Thedetailedinformationofclinicaltrialinstitution,agreementoftrialresultspublishing,financeandinsurancecanbeindicatedinthetrialprotocolorcanalsomakeanotheragreementtospecifiedit.Article29Theclinicaltrialinmu

45、lti-centershallbecarriedoutbyanumberofinvestigatorsinaccordancewiththesametrialprotocolindifferentclinicaltrialinstitutionsatthesametime.Thedesignandimplementationofthetrialprotocolshallatleastincludethefollowingcontents:Thetrialprotocolshallbeorganizedtoformulatebythesponsoranddeterminedbyeachclini

46、caltrialinstitutionandtheinvestigator,andthecaseshouldbeclearedthattheinvestigatorofleadunitofclinicaltrialinstitutioniscoordinatinginvestigator.Thecoordinatinginvestigatorisinchargeoftheworkcoordinationofclinicaltrialinstitutionsintheprocessofclinicaltrialandorganizingthemeetingofinvestigatorsinthe

47、early,middle,latestageofclinicaltrial,andresponsiblefortheimplementationofthewholetrialwiththesponsor;Eachclinicaltrialinstitutionshouldcarryoutandcompleteclinicaltrialsatthesametimeinprinciple;Samplesizeofeachclinicaltrialinstitutionandthedistributionandthereasonformeetingstatisticsanalysisrequirem

48、ents;Theplanofthesponsorandclinicaltrialinstitutionsontrialtrainingandtherequirementfortrainingrecord;Establishingtheprocedureforthetransmission,management,auditandqueryoftrialdata,andrequiringclearlythatthetrialdataofclinicaltrialinstitutionandrelevantdocumentsshouldbemanagedandanalyzedcentrallybyl

49、eadunit;Aftertheclinicaltrialsinmulti-centerarecompleted,theinvestigatorofeachclinicaltrialinstitutionshouldprovideabriefsummaryoftheclinicaltrial,afterthebriefsummaryandcasereportformarecheckedaccordingtotheprovisions,submitthemtothecoordinatinginvestigatorforsummarizingtofinishasummaryreport.Chapt

50、erVResponsibilitiesofethicscommitteeArticle30Theethicscommitteeofclinicaltrialinstitutionofmedicaldevicesshallatleastbecomposedof5memberswithdifferentgenders,includingmedicalprofessionalsandnonmedicalprofessionals.Thereshouldbeatleastonelegalworkerandonepersonnelnotintheclinicaltrialinstitutionamong

51、nonmedicalprofessionals.Theethicscommitteeshouldhavethequalificationandexperiencesinscience,medicine,andethicsandotheraspectsofassessingandevaluatingtheclinicaltrial.Allthecommitteemembersshouldbefamiliarwithethicalcodesandrelevantprovisionsforclinicaltrialsofmedicaldevicesandcomplywiththerulesofeth

52、icscommittee.Article31EthicscommitteeofmedicaldevicesshouldcomplywiththeethicalcodesofWorldMedicalAssociationDeclarationofHelsinkiandtheprovisionsoffoodanddrugregulatoryauthority,establishcorrespondingworkingproceduresandformdocuments,andfulfilltheobligationsinaccordancewiththeworkingprocedures.Them

53、embersindependentoftheinvestigatorandsponsorintheethicscommitteehavetherighttocommentandparticipateinvoterelatedtothetrial.Article32Theethicscommitteeshallinforminadvancewhenholdingameeting,thenumberofpersonnelparticipatedinreviewandvoteshallnotbelessthan5,andanydecisionshallbemadeinthecasethatmoret

54、hanhalfofthemembersinethicscommitteehaveapprovedit.Theinvestigatorshallprovideanyinformationrelatedtothetrial,butshallnotparticipateinreview,voteorcomment.TheethicscommitteeshallinviteexpertsinrelevantfieldswhenreviewingsomespecialtrialsArticle33Theethicscommitteeshallstrictlyreviewthetrialprotocola

55、ndrelevantdocumentationfromtheperspectiveofprotectingtherightsandinterestsofsubjects,andshallfocusonthefollowingcontents:Qualification,experiencesoftheinvestigatorandwhetherhehassufficienttimetojointheclinicaltrial;Whetherthestaffingandequipmentconditionsofclinicaltrialinstitutionsmeettherequirement

56、softhetrial.Whetherthelevelofrisksthatthesubjectsmaysubjectedtoissuitabletotheexpectedbenefitsofclinicaltrial.Whetherthetrialprotocoltakefullaccountofethicalprinciplesandmeetthescientificnature,includingwhethertheresearchpurposeisappropriate,whethertherightsandinterestsofsubjectsareprotected,whether

57、theprotectionagainsttherisksthatotherpersonsmaysufferandthemethodsforsubjectsinclusionarescientific.Methodforsubjectsinclusion,whethertheinformationdatarelatedtothetrialthatprovidedtothesubjectsortheguardiansiscomplete,whethersubjectscanunderstand,themethodforobtaininginformedconsentformisappropriat

58、e;Theethicscommitteeshouldorganizetherepresentativesofsubjectstotestthelevelthattheycanunderstandthedataifnecessaryandassesswhethertheinformedconsentformisappropriate,theassessmentresultshallberecordedinwrittenformandkeptfor10yearsaftertheclinicaltrialisover.Whetherthetreatmentandinsurancemeasuresar

59、eadequateiftheinjuryordeathrelatedtotheclinicaltrialhappentosubjects.Whethertheamendmentsontrialprotocolcanbeaccepted.Whetherthepossiblehazardstosubjectscanbeanalyzedandevaluatedregularlyduringtheclinicaltrials.Whetherthedeviationoftrialprotocolthatmayaffecttherightsandinterestsofsubjects,safetyandh

60、ealth,oraffectingthescientificnatureandintegrityofthetrialcanbeaccepted.Article34Acollaborativereviewprocessshallbeestablishedfortheethicalreviewofclinicaltrialinmulticenterbytheethicscommitteeofleadunittoensuretheconsistencyandtimelinessofthereview.Theethicscommitteeofleadunitshallberesponsibleforr