医疗器械临床试验质量管理规范英文版文档格式.docx
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医疗器械临床试验质量管理规范英文版文档格式.docx
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medicalequipmentspecificationforthequalitycontrolofclinicaltrialof>
hasbeenstatefoodandDrugAdministrationintheexecutivemeetingofthe,nationalhealthandFamilyPlanningCommission,directorofthecommitteemeetingexaminedandadopted,isherebypromulgated,sinceJune1,2016implementation.
DirectorBiJingquan
DirectorLiBin
March1,2016
Standardforqualitymanagementofmedicaldeviceclinicaltrials
Chapteroneisthefirstchapter
Thefirstistostrengthenthemanagementofmedicaldeviceclinicaltrials,themaintenanceprocessforclinicaltrialsofmedicaldevicesinrightsandinterests,andtoguaranteethemedicaldeviceclinicaltrialsprocessspecification,realresults,science,reliableandtraceable,accordingto<
thesupervisionandadministrationofMedicalDevicesRegulations>
formulatedthisspecification.
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.Thedevelopmentofthetestwithmedicalequipmentshallmeettheapplicablerequirementsofthemedicaldevicequalitymanagementsystem.
Thenineclinicaltrialsofmedicaldevicesshallbeintwoormorethantwomedicaldeviceclinicaltrialinstitution.Selectedtestinginstitutionsshallbewithoutqualificationaccreditationofmedicalinstrumentclinicaltrialinstitution,andfacilitiesandconditionsshallmeetthesafetyeffectivelyclinicaltrialexperience.Researchersshouldbeabletobeartheclinicaltrialsofspecialty,qualificationandabilityandtrained.QualificationofmedicalinstrumentclinicaltrialinstitutionidentifiedmanagementmeasuresshallbeformulatedseparatelybytheStateFoodanddrugadministrationshall,jointlywiththeMinistryofhealthandFamilyPlanningCommission.
Article10beforeclinicaltrials,thesponsorandclinicaltrialinstitutionsandresearchersshouldtestdesign,testqualitycontrol,testthedivisionofresponsibilities,sponsortobearthecostsassociatedwiththeclinicaltrialandtestinmayoccurdamagedealingwithprinciplestoreachawrittenagreement.
No.:
000000000000025415
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,researchersshouldfullytosubjectso
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- 医疗器械 临床试验 质量管理 规范 英文