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FG-0601025GoodClinicalPracticeforMedicalDevices(No.25OrderofCFDAandNHFPC)OrderofChinaFoodandDrugAdministrationandNationalHealthandFamilyPlanningCommissionofChinaNo.25AdoptedatthemeetingofCFDAandNHFPC,thispracticeisherebypromulgated,andshalltakeeffectasofJune1,.
　　　　　　　　　　　　　　　　　　　　　　　　　　　Director BiJingquanDirectorLiBinMarch1,GoodClinicalPracticeforMedicalDevicesChapter1GeneralprovisionsArticle1ThePracticeisformulatedinaccordancewiththeRegulationsontheSupervisionandAdministrationofMedicalDevicesinordertofurtherstrengthenthemanagementofclinicaltrialsofmedicaldevices,protecttherightsandbenefitsoftrialsubjectsandassuretheclinicaltrialprocedurestandard,truthful,scientific,reliableandtraceable.Article2AlltheclinicaltrialsofmedicaldeviceswithintheterritoryofthePeople'sRepublicofChinashallbeconductedaccordingtothepractice.ThePracticecoversthewholeprocedureofclinicaltrialofmedicaldevices,includingtheprotocoldesign,conduction,monitoring,audit,inspection,collectionofdata,record,analysisandsummaryandreportofclinicaltrial,etc.Article3ClinicaltrialofmedicaldevicesmentionedinthisPracticereferstotheprocessofconfirmingandverifyingthesafetyandefficacyofthemedicaldeviceintendedtoapplyregistrationundernormalconditioninqualifiedclinicaltrialinstitutionsofmedicaldevices.Article4Clinicaltrialsofmedicaldevicesshallcomplywiththeprincipleoflegal,ethicandscience.Article5Foodanddrugregulatoryauthorityaboveprovincelevelareresponsibleforthesupervisionandmanagementofclinicaltrailsofmedicaldevices.ThecompetentdepartmentofNationalHealthandFamilyPlanningCommissionshallstrengthenthemanagementofclinicaltrailsofmedicaldeviceswithin the scope of its duties.FoodanddrugregulatoryauthorityandthecompetentdepartmentofNHFPCshallestablishtheinformationnotificationsystemonqualitymanagementofmedicaldeviceclinicaltrialsandstrengthentheinformationnotificationontheapprovalforconductingclinicaltrialofClassIIImedicaldevicesandthemedicaldeviceslistedinthemanagementcatalogoflarge medical equipmentcollocation in Chinaandthedataofthesupervisionandmanagementonrelevantclinicaltrial.ChapterIIPreparationbeforeclinicaltrialsArticle6Thereshouldbesufficientscientificbasisandcleartrialpurposetoconductclinicaltrialsofmedicaldevices,andtheexpectedbenefitsandriskstothehealthofsubjectsandpublicshallbeweighed,theexpectedbenefitsshouldexceedthepossibledamage.Article7Beforeclinicaltrial,thesponsorshallcompletethepre-clinicalstudyofinvestigationalmedicaldevices,includingthedesignofproducts(structureandcomposition,workingprincipleandmechanismofaction,intendeduse,applicationscopeandapplicabletechnicalrequirements)andqualityinspection,animaltrialandanalysisreport,etc,andtheresultsshallsupporttheclinicaltrial.Theresultsofqualityinspectionincludereportofself-inspectionandthequalifiedreportforregistrationinspectionissuedbyaqualifiedinspectionagencywithinoneyear.Article8Beforeclinicaltrial,thesponsorshallprepareadequateinvestigationalmedicaldevices.Thedevelopmentofinvestigationalmedicaldevicesshallmeetrelevantrequirementsofqualitymanagementsystemofmedicaldevices.Article9Clinicaltrialsofmedicaldevicesshallbeconductedintwoormorethantwoclinicaltrialinstitutionsofmedicaldevices.Theselectedtrailinstitutionshallbequalifiedclinicaltrialinstitutionofmedicaldevicesandthefacilitiesandconditionsshallmeettherequirementsforconductingclinicaltrialssafelyandeffectively.Theinvestigatorshouldhavetheprofessionalexpertise,qualificationsandabilitytoundertaketheclinicaltrialandshouldhavebeentrained.Administrativemeasuresforthequalification recognitionofclinicaltrialinstitutionsofmedicaldevices shall be formulated separately byChinaFoodandDrugAdministrationandNationalHealthandFamilyPlanningCommissionofChina.Article10Beforeclinicaltrial,thesponsor,clinicaltrialinstitutionandinvestigatorshallmakea written agreementontrialdesign,qualitycontroloftrial,divisionofresponsibilitiesinthetrial,thecostofclinicaltrialsundertakenbythesponsorandthetreatmentprincipleofinjuriesthatmayoccurinthetrial.Article11Clinicaltrialsshouldbeapprovedbyethicscommitteeofclinicaltrialinstitutions.MedicaldeviceslistedinthedirectoryofClassIIImedicaldeviceclinicaltrialshallalsobeapprovedbyCFDA.Article12Beforeclinicaltrial,thesponsorshouldfiletolocalfoodanddrugregulatoryauthorityoftheprovince,theautonomousregionorthemunicipalitydirectlyundertheCentralGovernment.ThefoodanddrugregulatoryauthorityacceptingthefillingshouldreportthefilingsituationstothefoodanddrugregulatoryauthorityandthecompetentauthorityofNHFPCinthesamelevelwheretheclinicaltrialinstitutionislocated.ChapterIIIProtectionofrightsandbenefitsoftrialsubjectsArticle13ClinicaltrialsofmedicaldevicesshouldbeconductedinaccordancewiththeethicalprinciplesinWorldMedicalAssociationDeclarationofHelsinki.Article14Ethicalreviewandinformedconsentarethemainmeasurestoprotecttherightsandbenefitsofsubjects.Eachpartyinvolvedintheclinicaltrialshallundertakecorrespondingethicalresponsibilitiesaccordingtotheirdutiesinthetrial.Article15Thesponsorshouldavoidtocauseundueinfluenceormisleadingtosubjects,clinicaltrialinstitutionsandtheinvestigatorandotherclinicaltrialparticipantsorrelatedparties.Clinicaltrialinstitutionandtheinvestigatorshouldavoidtocauseundueinfluenceandmisleadingtosubjects,thesponsorandotherclinicaltrialparticipantsorrelatedparties.Article16Thesponsor,clinicaltrialinstitutionandtheinvestigatorshallnotexaggeratethecompensationmeasuresforparticipatinginclinicaltrialsandmisleadthesubjectstoparticipateinclinicaltrials.Article17Beforeclinicaltrial,thesponsorshallsubmitthefollowingdocumentstoethicscommitteethroughtheinvestigatorandthemanagementdepartmentofmedicaldeviceclinicaltrialofclinicaltrialinstitution:(1)Protocolofclinicaltrial;(2)Investigator’sbrochure;(3)Textofinformedconsentformandanyotherwrittendocumentsprovidedtosubjects;(4)Procedural documentsforrecruitingsubjectsandpublicity;(5)Textofcasereportform;(6)Self-inspectionreportandtheinspectionreportforproductregistration;(7)Resumes,professionalexpertise,ability,trainingoftheinvestigatorandotherdocumentstoprovequalifications;(8)Overviewofthefacilitiesandconditionsofclinicaltrialinstitutionmeetingtrial;(9)Declarationthatthedevelopmentofinvestigationalmedicaldevicesmeetrelevantrequirementsofapplicablequalitymanagementsystemofmedicaldevices;(10)Otherdocumentsrelatedtoethicalreview.Ethicscommitteeshouldupholdtheprinciplesofethicsandscience,reviewandsupervisetheimplementationofclinicaltrials.Article18Ifoneofthefollowingcasesoccurduringtheclinicaltrial,theinvestigatorshallreportintimetothemanagementdepartmentofmedicaldeviceclinicaltrialofclinicaltrialinstitution,informthesponsorandreporttheethicscommitteethroughthemanagementdepartment:(1)Seriousadverseevents;(2)Reportofprogress,includingsummaryforsafetyandreportofdeviation;(3)Foranyrevisefortheapproveddocumentsbyethicscommittee,thenonsubstantivechangesthatdonotaffecttherightsandbenefits,safetyandhealthofsubjectsorisnotrelatedtothepurposeorendpointofclinicaltrialdon’tneedtobereportedinadvance,butshallbenotifiedinwrittenformafterwards.(4)Suspension,terminationorrequiringforrestoringtheclinicaltrialaftersuspension;(5)deviationofclinicaltrialprotocolaffectingtherightsandbenefits,safetyandhealthofsubjectsorthescientific nature.Inordertoprotecttherightsandbenefits,safetyandhealthofsubjects,thedeviationinanemergencythatcan’tbereportedintimeshallbereportedassoonaspossibleinwrittenformafterwardsaccordingtorelevantprovisions.Article19Intheprocessofclinicaltrial,inthecastthatrevisingtheclinicaltrialprotocol,informedconsentformandotherdocuments,requiringfordeviationandrestoringthesuspendedclinicaltrial,thetrialshallcontinuetobeimplementedafterbeingapprovedbytheethicscommittee.Article20Theminors,pregnantwomen,oldpeople,personswithmentaldisability,patientsindangerandothersshallbeavoidedtobechosenassubjects;iftheyareneededtobechosenforsomenecessaryreason,relevantadditionalrequirementsprovidedbytheethicscommitteeshallbecompliedwith,andthespecialdesignshallbeconductedfortheirhealthconditionsintheclinicaltrialanditshallbehelpfultotheirhealth.Article21Beforethesubjects’participatingintheclinicaltrial,theinvestigatorshallexplainthedetailsofclinicaltrialtothesubjects,the guardians of persons without or with limited capacity for civilconduct,includingrecognized,foreseeablerisksandpossibleadverseevents,etc.Thesubjectsandguardiansshallsigntheirnameandthedateontheinformedconsentformaftersufficientanddetainedexplanation,andtheinvestigatorshallalsoneedtosignhisnameandthedate.Article22Thefollowingcontentsandexplanationsoftheitemsshallbeincludedintheinformedconsentform:(1)Nameoftheinvestigatorandrelevantinformation;(2)Nameofclinicaltrialinstitution;(3)Name,purpose,methodandcontentsofthetrial;(4)Processandthetermofvalidityofthetrial;(5)Sourcesoffundingforthetrialandpossibleconflictofinterest;(6)Expectedpossiblebenefitsforsubjects,recognizedandforeseeablerisksandpossibleadverseevents;(7)Alternativemethodofdiagnosisandtreatmentthatsubjectscanobtainandthepotentialbenefitsandrisks;(8)Differentgroupswhichthesubjectswillbeassignedtointhetrialshallbeexplained,ifrequired;(9)Thesubjectsshallbevoluntarytoparticipateinthetrialandhavetherighttowithdrawatanystageofthetrialwithoutdiscriminationorretaliation,andtheirmedicaltreatment,rightsandinterestsarenotaffected;(10)Thepersonneldatathatthesubjectsareinformedtoparticipateinthetrialisconfidential,buttheethicscommittee,foodanddrugregulatoryauthority,thecompetentauthorityofNHFPCorthesponsorcanlookupthepersonneldataintheneedtoworkaccordingtotheprescribedprocedures;(11)Incaseofinjuryrelatedtothetrial,thesubjectsshallreceivetreatmentandeconomiccompensation;(12)Thesubjectsshallknowtheinformationrelatedtothematanytimeduringthetrial;(13)Freeitemsfordiagnosisandtreatmentandotherrelatedsupportthatsubjectsmayobtainduringthetrial.Thelanguageandwordsthatthesubjectsorguardianscanunderstandshouldbeusedfortheinformedconsentform.Theinformedconsentformshallnotcontainanycontentsthatwillcausethesubjectstogiveuptheirlegalrightsandinterestsandwillexemptfromtheresponsibilitiesofclinicaltrialinstitutionsandtheinvestigator,thesponsorortheagent.Article23Thefollowingrequirementsshallbemettoobtaintheinformedconsent:(1)Thedisabledsubjectscanalsoparticipateinclinicaltrialiftheethicscommitteeagreeinprincipleandtheinvestigatorconsidersthatparticipatinginthetrialcanmeetthesubjects’interests,buttheguardianofthesubjectshouldsignhisnameandnotethedatebeforethetrial;(2)Ifboththesubjectandtheguardianhavenoreadingability,thereshouldbeawitnessonthespotduringtheinformedprocess.Afterbeingexplainedtheinformedconsentformindetailandreadingitwhichisthesamewiththeoralinformedconsentandgettingtheoralagreementfromthesubjectorguardian,thewitnesscansignontheinformedconsentandnotethedate,thesignofthewitnessandtheinvestigatorshouldbeonthesameday.(3)Whenaminoristakenasasubject,theinformedconsentoftheguardianshallbeobtainedandtheinformedconsentformshallbesigned.Iftheminorcanmakeanintentionwhethertoparticipateinthetrialornot,theconsentofhisownshallalsobeaskedfor.(4)Ifimportantinformationorunexpectedclinicaleffectrelatedtotheinvestigationalmedicaldevicesarefound,relevantcontentsoftheinformedconsentformshallbemodified,themodifiedinformedconsentformshouldbere-signedforconfirmationbysubjectsorguardiansafterbeingapprovedbytheethicscommittee.Article24Thedateofformulationorthedateoftherevisedversionshallbeindicatedintheinformedconsentform.Iftheinformedconsentformisrevisedduringthetrial,therevisedinformedconsentformneedtobeapprovedbytheethicscommitteebeforeimplementation.Aftertherevisedinformedconsentformissubmittedtotheclinicaltrialinstitution,anewinformedconsentformshallbesignedifthesubjectsofalltheunfinishedtrialareaffected.Article25Thesubjectshavetherighttowithdrawfromanystageofclinicaltrialsandarenotliableforanyeconomicresponsibility.ChapterIVProtocolofclinicaltrialsArticle26Whenconductingclinicaltrialsofmedicaldevices,thesponsorshouldorganizetoformulatescientificandreasonableclinicaltrialprotocolaccordingtotheclassification,risksandintendeduseofinvestigationalmedicaldevices.Article27ForthenewproductsthathavenotapprovedtomarketinChinaorabroad,thesafetyandperformancehavenotconfirmedbymedical,thefeasibilitytestoflittlesampleshouldbecarriedoutfirstbeforeclinicaltrialprotocolisdesigned.Thenthesamplesizeshallbedeterminedaccordingtostatisticalrequirementsandthefollow-upclinicaltrialsshallbecarriedoutafterthesafetyisinitiallyconfirmed.Article28Theclinicaltrialprotocolofmedicaldevicesshouldcontainthefollowingcontents:(1)Generalinformation;(2)Backgrounddataforclinicaltrials;(3)Purposeforclinicaltrials;(4)Designofclinicaltrials;(5)Evaluationmethodforsafety;(6)Evaluationmethodforefficacy;(7)Considerationforstatistics;(8)Provisionsforrevisingclinicaltrialprotocol;(9)Provisionsforadverseeventsandreportofdevicedefect;(10)Directaccesstosourcedataanddocuments;(11)Ethicalissuesrelatedtoclinicaltrialsandthedescriptionandthetextofinformedconsentform;(12)Datahandlingandrecordkeeping;(13)Financingandinsurance;(14)Agreementoftrialresultspublishing.Partoftheabovecontentscanbeincludedinotherrelevantdocumentationsoftheprotocolsuchasinvestigator’sbrochure.Thedetailedinformationofclinicaltrialinstitution,agreementoftrialresultspublishing,financeandinsurancecanbeindicatedinthetrialprotocolorcanalsomakeanotheragreementtospecifiedit.Article29Theclinicaltrialinmulti-centershallbecarriedoutbyanumberofinvestigatorsinaccordancewiththesametrialprotocolindifferentclinicaltrialinstitutionsatthesametime.Thedesignandimplementationofthetrialprotocolshallatleastincludethefollowingcontents:(1)Thetrialprotocolshallbeorganizedtoformulatebythesponsoranddeterminedbyeachclinicaltrialinstitutionandtheinvestigator,andthecaseshouldbeclearedthattheinvestigatorofleadunitofclinicaltrialinstitutioniscoordinatinginvestigator.(2)Thecoordinatinginvestigatorisinchargeoftheworkcoordinationofclinicaltrialinstitutionsintheprocessofclinicaltrialandorganizingthemeetingofinvestigatorsintheearly,middle,latestageofclinicaltrial,andresponsiblefortheimplementationofthewholetrialwiththesponsor;(3)Eachclinicaltrialinstitutionshouldcarryoutandcompleteclinicaltrialsatthesametimeinprinciple;(4)Samplesizeofeachclinicaltrialinstitutionandthedistributionandthereasonformeetingstatisticsanalysisrequirements;(5)Theplanofthesponsorandclinicaltrialinstitutionsontrialtrainingandtherequirementfortrainingrecord;(6)Establishingtheprocedureforthetransmission,management,auditandqueryoftrialdata,andrequiringclearlythatthetrialdataofclinicaltrialinstitutionandrelevantdocumentsshouldbemanagedandanalyzedcentrallybyleadunit;(7)Aftertheclinicaltrialsinmulti-centerarecompleted,theinvestigatorofeachclinicaltrialinstitutionshouldprovideabriefsummaryoftheclinicaltrial,afterthebriefsummaryandcase report formarecheckedaccordingtotheprovisions,submitthemtothecoordinatinginvestigatorforsummarizingtofinishasummaryreport.ChapterVResponsibilitiesofethicscommitteeArticle30Theethicscommitteeofclinicaltrialinstitutionofmedicaldevicesshallatleastbecomposedof5memberswithdifferentgenders,includingmedicalprofessionalsandnonmedicalprofessionals.Thereshouldbeatleastonelegalworkerandonepersonnelnotintheclinicaltrialinstitutionamongnonmedicalprofessionals.Theethicscommitteeshouldhavethequalificationandexperiencesinscience,medicine,andethicsandotheraspectsofassessingandevaluatingtheclinicaltrial.Allthecommitteemembersshouldbefamiliarwithethical codesandrelevantprovisionsforclinicaltrialsofmedicaldevicesandcomplywiththerulesofethicscommittee.Article31EthicscommitteeofmedicaldevicesshouldcomplywiththeethicalcodesofWorld Medical Association Declaration of Helsinki andtheprovisionsoffoodanddrugregulatoryauthority,establishcorrespondingworkingproceduresandformdocuments,andfulfilltheobligationsinaccordancewiththeworkingprocedures.Themembersindependentoftheinvestigatorandsponsorintheethicscommitteehavetherighttocommentandparticipateinvoterelatedtothetrial.Article32Theethicscommitteeshallinforminadvancewhenholdingameeting,thenumberofpersonnelparticipatedinreviewandvoteshallnotbelessthan5,andanydecisionshallbemadeinthecasethatmorethanhalfofthemembersinethicscommitteehaveapprovedit.Theinvestigatorshallprovideanyinformationrelatedtothetrial,butshallnotparticipateinreview,voteorcomment.TheethicscommitteeshallinviteexpertsinrelevantfieldswhenreviewingsomespecialtrialsArticle33Theethicscommitteeshallstrictlyreviewthetrialprotocolandrelevantdocumentationfromtheperspectiveofprotectingtherightsandinterestsofsubjects,andshallfocusonthefollowingcontents:(1)Qualification,experiencesoftheinvestigatorandwhetherhehassufficienttimetojointheclinicaltrial;(2)Whetherthestaffingandequipmentconditionsofclinicaltrialinstitutionsmeettherequirementsofthetrial.(3)Whetherthelevelofrisksthatthesubjectsmaysubjectedtoissuitabletotheexpectedbenefitsofclinicaltrial.(4)Whetherthetrialprotocoltakefullaccountofethicalprinciplesandmeetthescientificnature,includingwhethertheresearchpurposeisappropriate,whethertherightsandinterestsofsubjectsareprotected,whethertheprotectionagainsttherisksthatotherpersonsmaysufferandthemethodsforsubjectsinclusionarescientific.(5)Methodforsubjectsinclusion,whethertheinformationdatarelatedtothetrialthatprovidedtothesubjectsortheguardiansiscomplete,whethersubjectscanunderstand,themethodforobtaininginformedconsentformisappropriate;Theethicscommitteeshouldorganizetherepresentativesofsubjectstotestthelevelthattheycanunderstandthedataifnecessaryandassesswhethertheinformedconsentformisappropriate,theassessmentresultshallberecordedinwrittenformandkeptfor10yearsaftertheclinicaltrialisover.(6)Whetherthetreatmentandinsurancemeasuresareadequateiftheinjuryordeathrelatedtotheclinicaltrialhappentosubjects.(7)Whethertheamendmentsontrialprotocolcanbeaccepted.(8)Whetherthepossiblehazardstosubjectscanbeanalyzedandevaluatedregularlyduringtheclinicaltrials.(9)Whetherthedeviationoftrialprotocolthatmayaffecttherightsandinterestsofsubjects,safetyandhealth,oraffectingthescientificnatureandintegrityofthetrialcanbeaccepted.Article34Acollaborativereviewprocessshallbeestablishedfortheethicalreviewofclinicaltrialinmulticenterbytheethicscommitteeofleadunittoensuretheconsistencyandtimelinessofthereview.Theethicscommitteeofleadunitshallberesponsibleforreviewingtheethicalrationalityandscientificnatureoftrialprotocolbeforethetrialiscarriedoutbyeachclinicaltrialinstitution,theethicscommitteeofotherclinicaltrialinstitutionsparticipatedinthetrialshalladoptmeetingreviewordocumentationreviewtoreviewthefeasibilityofthetrialinthisclinicaltrialinstitutionunderthepremiseoftakingthereviewopinionsoftheethicscommitteeofleadunit,includingthequalificationandexperiencesoftheinvestigator,equipmentandconditions,etc..Theethicscommitteeofotherclinicaltrialinstitutionsshallnotproposeamendmentsonthedesignoftrialprotocolanymore,buthehastherighttodisapprovetocarryoutthetrialinhisclinicaltrial.Article35Theethicscommitteeshouldholdameeting,reviewanddiscuss,issuewrittenopinions,stampitandattachthelist,professionalandsignatureofattendance.Theopinionsofethicscommitteeshallbe：(1)Approval;(2)Approvalafternecessarymodification;(3)Disapproval;(4)Suspendingandterminatingtheapprovedtrial.Article36Theethicscommitteeshalloversee and follow-upthetrialcarriedoutinthisclinicaltrialinstitutionandshallrequiretosuspendorterminatetheclinicaltrialinwrittenformatanytimeiffindingsuchcasesthattherightandinterestsofsubjectscannotbeprotected.Thesuspendedclinicaltrialshouldnotberestoreduntiltheethicscommitteeapproveit.Article37Theethicscommitteeshallkeepalltherelevantrecordsforatleast10yearsafterthecompletionofclinicaltrials.ChapterVIResponsibilitiesofsponsorsArticle38Thesponsorisinchargeoftheinitiation,application,organizationandmonitoringofclinicaltrialsandresponsiblefortheauthenticityandreliabilityofclinicaltrials.Thesponsorisusuallyamanufacturerofmedicaldevices.Ifthesponsorisaoverseasinstitution,heshallappointanagentwithintheterritoryofchina.Article39Thesponsorisresponsiblefororganizingtoformulateandmodifyinvestigator’sbrochure,clinicaltrialprotocol,informedconsentform,casereportform,relevantstandardoperationprocedureandotherrelevantdocuments,andisresponsibl