《医疗器械临床试验质量管理规范》英文版.docx
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《医疗器械临床试验质量管理规范》英文版.docx
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《医疗器械临床试验质量管理规范》英文版
《医疗器械临床试验质量管理规范》英文版
StateFoodandDrugAdministration
NationalHealthandFamilyPlanningCommission
Numbertwenty-fifth
DirectorBiJingquan
DirectorLiBin
March1,2016
Standardforqualitymanagementofmedicaldeviceclinicaltrials
Chapteroneisthefirstchapter
Thefirstistostrengthenthemanagementofmedicaldeviceclinicaltrials,themaintenanceprocessforclinicaltrialsofmedicaldevicesinrightsandinterests,andtoguaranteethemedicaldeviceclinicaltrialsprocessspecification,realresults,science,reliableandtraceable,accordingto
Article2withintheterritoryofthepeople'sRepublicofChinatocarryouttheclinicaltrialofmedicalapparatusandinstruments,shallcomplywiththespecification.Thisspecificationcoversthewholeprocessofmedicaldeviceclinicaltrials,includingdesignofclinicaltrials,theimplementationof,monitoring,verification,inspection,anddataacquisition,record,andanalyzethesummarizingandreporting.
Thethirdsectionofthisspecificationreferredtointheclinicaltrialofmedicalapparatusandinstruments,referstointheaccreditationofmedicalinstrumentclinicaltrialinstitution,intendstoapplyfortheregistrationofmedicaldeviceinthenormalconditionsofuseissafeandeffectiveforconfirmationorverificationprocess.
Fourthclinicaltrialsofmedicaldevicesshallcomplywiththeprinciplesoflaw,ethicalprinciplesandscientificprinciples.
Article5atorabovetheprovinciallevelfoodanddrugsupervisionandmanagementdepartmentsresponsibleforthesupervisionandmanagementofmedicaldeviceclinicaltrials.Healthandfamilyhealthdepartmentincharge,withinitsscopeoffunctionsandduties,strengthentheclinicaltrialofmedicalapparatusandinstrumentsmanagement.Foodanddrugsupervisionandmanagementdepartments,healthandfamilyhealthdepartmentsshouldestablishthemedicalqualityofclinicaltrialmanagementinformationreportingmechanism,strengthentheclassIIImedicaldevices,includedinthenationalconfigurationoflargemedicalequipmentqualitymanagementobjectiveofmedicalapparatusandinstrumentstocarryoutexaminationandapprovalofclinicaltrialsandthecorrespondingclinicaltrialsupervisionandmanagementofdatacommunications.
Thesecondchapteristhepreparationbeforeclinicaltrial
Article6theclinicaltrialofmedicalapparatusandinstrumentsshallhavesufficientscientificbasisandtheclearpurposeofthetest,andweighonexpectedandthepublichealthbenefitandrisk,expectedbenefitshouldexceedthepossibledamage.
Article7beforeclinicaltrials,thesponsorshalltestdoneinpreclinicalstudiesofmedicalapparatusandinstruments,includingproductdesign(structure,workingprincipleandmechanismofaction,isexpectedtouseandscopeofapplication,theapplicabletechnicalrequirementsandqualityinspection,animaltestingandriskanalysisandresultsshouldbeabletosupporttheclinicaltrial.Qualityinspectionresultsincludingselfinspectionreportandaqualifiedinspectionagencyissuedayearwithintheproductregistrationinspectionreport.
Priortotheeighthclinicaltrials,theapplicantshouldprepareadequatetestingofmedicalequipment.Thedevelopmentofthetestwithmedical
institutionidentifiedmanagementmeasuresshallbeformulatedseparatelybytheStateFoodanddrugadministrationshall,jointlywiththeMinistryofhealthandFamilyPlanningCommission.
Article10beforeclinicaltrials,thesponsorandclinicaltrialinstitutionsandresearchersshouldtestdesign,testqualitycontrol,testthedivisionofresponsibilities,sponsortobearthecostsassociatedwiththeclinicaltrialandtestinmayoccurdamagedealingwithprinciplestoreachawrittenagreement.
Article11clinicaltrialsshouldobtainconsentoftheclinicaltrialofmedicalapparatusandinstrumentsinstitutionalethicscommittee.IncludedintheneedforclinicaltrialsandapprovalofclassIIImedicaldevicesdirectory,shouldalsobeapprovedbytheStateFoodanddrugadministration.
Article12priortoclinicaltrials,thesponsorshallbetothelocationofprovinces,autonomousregions,municipalfoodanddrugsupervisionandmanagementdepartmentsfortherecord.Acceptfilingoffoodanddrugsupervisionandadministrationdepartmentshallrecordthesituationinformedclinicaltrialinstitutionislocatedatthesameleveloffoodanddrugsupervisionandmanagementdepartments,aswellashealthandfamilyhealthdepartments.
Thethirdchapteristheprotectionoftherightsandinterestsofthesubjects
ThirteenthclinicaltrialsofmedicaldevicesshallcomplywiththeethicalstandardssetbytheHelsinkideclarationoftheworldmedicalassembly.
Thefourteenthethicalreviewandinformedconsentarethemainmeasurestoprotecttherightsandinterestsofthesubjects.Thepartiesinvolvedinclinicaltrialsshouldassumethecorrespondingethicalresponsibilitiesaccordingtotheirrespectiveresponsibilities.
Article15thesponsorshouldavoidundueinfluenceormisleadingtosubjects,clinicaltrialsandresearchandclinicaltrialparticipantsorrelatedparty.Clinicaltrialinstitutionsandresearchersshouldavoidundueinfluenceormisleadingtosubjects,thesponsorandotherparticipantsinclinicaltrialsorinterestedparties.
Sixteenthapplicants,clinicaltrialsandresearchersshouldnotexaggeratethecompensationmeasuresinvolvedinclinicaltrials,tomisleadtheparticipantstoparticipateinclinicaltrials.
Seventeenthpreclinicaltrials,theapplicantshallsubmitthefollowingdocumentstotheethicscommitteebyresearchersandclinicaltrialinstitutionofmedicalinstrumentclinicaltrialmanagement:
(a)clinicaltrialprogram;(two)researchersmanual;(three)writteninformedconsentdocumentandanyotheravailabletoparticipants(;four)recruitingsubjectsandproceduraldocumentstoitspropaganda;(five)thecasereportformtext;(six)selfinspectionreportandproductregistrationinspectionreport;(seven)researchersresume,professionalexpertise,skills,trainingandotherdocumentstoprovetheirqualifications;(eight)clinicaltrialinstitutionthefacilitiesandconditionstomeetthetestreview;(nine)withthedevelopmentofmedicaldevicesinaccordancewiththerelevantrequirementsofmedicalqualitymanagementsystemfortheteststatement;(ten)otherdocumentsrelatedtoethicalreview.Ethicscommitteeshallupholdtheprinciplesofethicsandscience,reviewandsupervisetheimplementationofclinicaltrials.
Eighteenthoneofthefollowingcircumstancesoccurinthecourseofclinicaltrials,researchersshouldreporttotheclinicaltrialinstitutionofmedicalinstrumentclinicaltrialmanagementdepartment,andthetimelynotificationoftheapplicant,theethicscommitteereport:
(a)seriousadverseevents;(two)progressreport,includingasummaryofsafetyanddeviationreports;(three)foranyamendmenthasbeenapprovedbytheethicscommitteeofthefile,doesnotaffecttherightsandinterestsofthesubjects,safetyandhealth,nonsubstantivechangeswithoutpriorreportsorclinicaltrialswiththepurposeorendnotrelated,butafterwardsshallnotifyinwriting;(four)tosuspend,terminateorsuspendtherequestaftertherecoveryofclinicaltrials(five;)affecttherightsandinterestsofthesubjects,fromclinicaltrialsorclinicaltrialsafetyandhealthscience,includingthedeviationofrequestandreportthedeviation.FortheprotectionofsubjectsWhereaperson'srights,securityandhealtharenotimmediatelyreportedinanemergency,itshallbereportedinwrittenformassoonaspossibleinaccordancewiththerelevantprovisions.
Article19intheprocessofclinicaltrials,asamendedclinicaltrialprotocolsandinformedconsentdocuments,requestdeviation,resumeapausedclinicaltrialsshouldbecancontinuetoimplementuntilitobtainthewrittenapprovaloftheethicscommittee.
Itisgoodtothehealtharticle20shouldbeavoidedasfaraspossibleselectionofminors,pregnantwomen,elderly,personswithmentalobstacleinlifecriticalpatientsassubjects,thatreallyneedtobeselected,itshallabidebytheethicscommitteeoftheadditionalrequirement.Inclinicaltrialsfortheirhealthisspeciallydesigned,andshouldbe.
article20shouldbeavoidedasfaraspossibleselectionofminors,pregnantwomen,elderly,personswithmentalobstacleinlifecriticalpatientsassubjects,thatreallyneedtobeselected,itshallabidebytheethicscommitteeoftheadditionalrequirement.Inclinicaltrialsfortheirhealthisspeciallydesigned,andshouldbe.
Article21insubjectsinclinicaltrials,researchersshouldfullytosubjectsornocapacityforcivilconduct,theguardianofthepersonofcivilactioncompetencelimitthatthedetailsoftheclinicaltrials,includingtheknown,itcanbepredictedtheriskandpossibleadverseevents.AfterfullanddetailedexplanationbythesubjectsortheirguardiansininformedconsentBooksignyournameanddate,researchersalsoneedtoininformedconsentBooksignyournameanddate.
Twenty-secondgeneralconsentshallincludethefollowingcontentsanddescriptionofmatters:
(a)theresearchersnameandrelevantinformation;(two)thenameofclinicaltrialin
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