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《医疗器械临床试验质量管理规范》英文版StateFoodandDrugAdministration
NationalHealthandFamilyPlanningCommission
Numbertwenty-fifth
<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.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)thenameofclinicaltrialinstitution;(three)thenameofthetrial,purpose,method,content;(four)testprocess,testperiod;(five)thesourcesoffundsandthepossibleconflictsofinterest;(six)theexpectedparticipantsmaybenefitandknown,riskcanbeforeseenandadverseeventsmayoccur;(seven)alternativetreatmentsubjectscanobtaintheinformationanditspotentialbenefitsandrisks;(eight)whenneeded,thatsubjectsmaybeassignedtodifferentgroupsofexperiments;(nine)subjectsparticipatedintheexperimentshouldbevoluntary,andatanystageofthetesthastherighttowithdrawwithoutdiscriminationorrevenge,themedicaltreatmentandTherightsandinterestsarenotaffected;(ten)toldthesubjectsinthestudyofpersonaldataisconfidential,buttheethicscommittee,foodanddrugsupervisionandmanagementdepartments,healthdepartmentsorsponsoratworkwhennecessaryinaccordancewiththeprescribedprocedures,canrefertothesubjectsinthestudyofpersonaldata;(eleven)ashappenedwiththerelatedtestthehurt,thesubjectscouldgettreatmentandeconomiccompensation;(twelve)thesubjectscanunderstandtherelatedinformationduringthetest;(thirteen)freeclinicprojectparticipantsmaybeobtainedduringthetestandotherrelatedsubsidies.Informedconsentshallbeadoptedbythesubjectsorguardianscanunderstandthelanguageandtext.Informedconsentshallnotcontainanycausesubjectstogiveupthelegitimaterightsandinterestsandexemptionfromclinicaltrialinstitutionsandresearchers,thesponsororTheagentshallberesponsibleforthecontent.
Twenty-thirdobtaininformedconsentshallalsomeetthefollowingrequirements:(a)thesubjectsincapacitated,iftheethicscommitteeagreedinprinciple,researchersbelievethatthesubjectsparticipatinginaclinicaltrialwithitsowninterests,canalsoenterclinicaltrials,butshouldtryandmarkedbytheGuardianSignatureDateprior.;(two)thesubjectsortheirguardianswithoutreadingability,intheprocessofknowledgeshouldhaveawitnesspresent,afteradetailedexplanationoftheinformedconsent,witnessesreadtheinformedconsentandoralinformedcontent,agreedtobythesubjectsortheircarepopulationhead,witnessesininformedconsentthebookofsignatureanddate,signatureofwitnessandtheresearcher'ssignatureshouldbeonthesameday.;(three)minorsassubjects,shouldobtaintheconsentoftheguardianandsignedinformedconsentDepartmentinformedconsent,minorsonwhethertoparticipateintestinganintention,shouldalsobetheirconsent.;(IV)foundrelatestomedicalapparatusandinstrumentsofimportantinformationorareexpectedtotesttheclinicalimpactofshallbeofinformedconsentbookcontentismodified,themodifiedinformedconsentbytheethicscommitteeapprovalshallbebythetestoritsguardianresignatureconfirmation.
Article24informedconsentbookshallbeindicatedintheformulationofdateorrevisedversionsofdate.Suchasinformedconsentinthetestintheprocessofrevision,revisedversionoftheinformedconsentimplementthebookbeforeagainbytheethicscommitteeagreedto.Revisededitionofinformedconsentbooksclinicaltrialmechanismafter,allbeforetheendofthetestprocessofthesubjectswereasaffectedbytheshallsignedtheinformedconsentforthenewlyrevised.
Twenty-fifthsubjectshavetherighttowithdrawfromanystageofclinicaltrialsandarenotsubjecttoanyfinancialresponsibility.Thefourthchapterclinicaltrialprogram
Twenty-sixthtocarryoutclinicaltrialsofmedicaldevices,theapplicantshouldbeinaccordancewiththecategoriesofmedicalequipmenttesting,risk,intendeduse,andotherorganizationstodevelopscientificandrationalclinicaltrialsprogram.
Article27notinsideandoutsidetheapprovedthelistingofnewproducts,safetyandperformancehasnotbeenconfirmedbymedical,clinicaltrialdesignshouldfirstconductafeasibilitytestforsmallsamples,tobeinitiallyrecognizedfortheirsafety,accordingtothestatisticalrequirementstodeterminethesamplesizetocarryoutthefollowingclinicaltrial.
Twenty-eighthclinicaltrialsprotocolshouldincludethefollowing:(a)generalinformation;(two)thebackgrounddatainclinicaltrials;(three)thepurposeoftheexperiment;(four)experimentaldesign;(five)safetyevaluationmethod;(six)effectivenessevaluationmethod;(seven)statisticalconsiderations;(eight)theprovisionsforclinicaltrialsprogram;(nine)theprovisionsofadverseeventsandequipmentdefectreport;(ten)directaccesstothesourcedatafile;(eleven)clinicaltrialsinvolvingethicalissuesandinstructionsandinformedconsentdocument;(twelve)dataprocessingandrecordkeeping;(thirteen)financialandinsurance;(fourteen)agreement.Thetestresultswerepublishedpartofthecontentscanbeincludedinotherrelateddocumentssuchasprojectresearchers.HandbookofclinicaltrialsSpecificinformationabouttheorganization,theresultsofthetrialpublishedagreement,financeandinsurancecanbeexpressedinthetestplan,youcanalsomakeaseparateagreementtobespecified.
Twenty-ninthmulticenterclinicaltrialbyanumberofresearchersinthesametestprograminclinicaltrialsindifferentperiod.Thedesignandimplementationofthetestplanshallatleastincludethefollowingcontents:(a)thetestplanandtheclinicaltrialinstitutionsandresearcherstodiscussidentifiedbytheapplicantorganization,andaclearleadtheunitofclinicaltrialinstitutionforthecoordinationofresearchers;(two)theresearchersresponsibleforcoordinatingtheworkofcoordinationbetweentheinstitutionofclinicaltrialprocessofclinicaltrials,clinicaltrialsinearly,middleandlateorganizationresearchersmeeting,responsiblefortheimplementationandthesponsorofthewholetesttogether;(three)theinstitutionofclinicaltrialtheprincipleshouldbecarriedoutoverthesameperiodandtheendofclinicaltrials;(four)theinstitutionofclinicaltrialtestsamplesizeanddistribution,withstatisticalanalysistoForreason;(5)thesponsorandtheclinicaltestunitsonexperimentaltrainingplanandtrainingrecordsrequirements;(VI)establishedtestdatatransfer,management,queryandverificationprocedure,especiallyclearrequirementsoftheinstitutionofclinicaltrialtestingthedatashouldbetheleadunitcentralizedmanagementandanalysis;(7)aftertheendofthemulticenterclinicaltrials,eachclinicaltrialinstitutionsresearchersshouldrespectivelyissuedasummaryofclinicaltrials,togetherwithacasereporttableinaccordancewiththeprovisionsoftheauditedoverbycoordinatingresearchsummaryreport.Fifthchapterethicscommitteeduties
Article30medicaldeviceclinicaltrialinstitutionethicscommitteeshallbebyatleastfivemembers,includingmedicalprofessionals,medicalprofessionals,whichshouldbethemembersofthedifferentgender.Nonmedicalspecialtycommitteeatleastalegalworkerandanamefortheclinicaltrialinstitutionotherthanthepersonnel.Theethicscommitteeshouldbewiththeassessmentandevaluationoftheclinicaltrialsofscience,medicineandethics,andotheraspectsofqualificationorexperience.Allmembersshouldbefamiliarwithethicalguidelinesfortheclinicaltrialofmedicalapparatusandinstrumentsandrelevantregulationsandabidebytheethicscommitteeoftheconstitution.
Article31medicalethicscommitteeshallcomplywiththeprovisionsofthe<worldmedicalassemblydeclarationofHelsinki>ethicalstandardsandfoodanddrugsupervisionandadministrationdepartmentandestablishthecorrespondingworkingproceduresandtheformationofthefileandworkinaccordancewiththeproceduresperformtheirduties.Theethicscommitteeindependenttomembersoftheresearchersandthesponsorhastherighttocommentandparticipateinrelevanttestvote.
Article32TheEthicsCommitteemeetingshallbenotifiedinadvance,toparticipateinthereviewandthenumberofvotingcannotbelessthanfive,makeanydecisionshouldbebyanethicscommitteecomposedbymorethanhalfofthemembers.Researcherscanprovideinformationonanyaspectoftherelevanttest,butshouldnotparticipateinthereview,voteorcomment.Ethicscommitteeinthereviewofsomespecialtest,caninviteexpertsinrelatedfields.
Thirty-thirdfromtheethicscommitteeshallsafeguardtherightsandinterestsofthesubjectsoftheperspectiveofstrictconsiderationtestschemeandrelateddocuments,andshallfocusonthefollowing:(a)theresearchersqualifications,experienceandwhetherthereissufficienttimetoparticipateintheclinicaltrial.(two)clinicaltrialinstitutionstaffingandequipmentconformtothetest.(three)thesubjectsmaysufferadegreeofriskandbenefitcomparedtotheexpectedtestisappropriate.(four)testprogramisfullyconsideredtheethicalprinciples,withscientificresearchpurposes,includingtheappropriatenessofsubjects'rightsareprotected,otherpersonsmaysuffertheriskandprotectionmethodparticipantsarescience.(five)subjectswereselectedtotestthemethod,therelevantinformationofthesubjectsortheirguardiansprovidedTheinformationiscomplete,whetherthesubjectscouldunderstand,obtaininginformedconsentisappropriate;whennecessary,theethicscommitteeshallorganizetheparticipantsonbehalfofthelevelofunderstandingofthetestdata,theevaluationofinformedconsentisappropriate,theassessmentresultsshallbetheendofthe10yearwrittenrecordandsavetoclinicaltrials(six.)subjectsiftheoccurrenceofclinicaltrialrelatedinjuryordeath,treatmentandinsurancemeasuresforadequacy.(seven)whethertheproposedamendmentstothetestschemeisacceptable.(eight)whethercanbecarriedoutinclinicaltrialsinregularevaluationmayharmtosubjectsfrom(nine).Thetestplanmayaffecttherightsandinterestsofthesubjects,safetyandhealth,oraffectthescientificnature,theintegrityofthetest,whetheritcanbeaccepted.
Ethicalreviewthirty-fourthmulticenterclinicaltrialshouldbeledbytheethicscommitteeresponsiblefortheestablishmentofcollaborativereviewprocedurestoensureconsistencyandtimelinessofthereviewwork.Thebeginningofeachclinicaltrialinstitutionbeforethetestshouldbeledbytheethicscommitteeresponsibleforexaminationandtestschemeofethicalrationalityandscientificity,participateinthetestofotherclinicaltrialinstitutionethicstheCommitteeintheprerequisiteofacceptingtheleadunitethicscommitteereviewcomments,canbeusedtorevieworfilereview,reviewthefeasibilityofthetrialsinthisclinicaltrialinstitutions,includingthequalificationandexperienceoftheequipmentandconditions,generallynolongeronthedesignschemeofthetestproposedamendments,butnotrightapprovedtestinclinicaltrials.
Article35TheEthicsCommitteereceivestheapplicationofclinicaltrialsofmedicaldevicesshallconveneameeting,discussthereview,issueawrittenopinion,seal,andattachedtoattendthemeetingofthepersonnellist,professionalandpersonalsignature.Theviewsoftheethicscommitteemaybe:(a)consent;(II)modificationsnecessaryconsent;(III)withoutconsent;(IV),tosuspendorterminatethetesthasbeenapproved.
Article36TheEthicsCommitteeshallbeofclinicaltrialsofthisclinicaltrialinstitutiontrackingsupervision,itisfoundthatthesubjects'rightsandinterestscannotgetsecuritysituation,canbeinanytimeuponwrittenrequesttosuspendorterminatethetrial.Clinicaltrialshavebeensuspended,withouttheconsentoftheethicscommitteeshouldnotbeallowedtoresume.
Thirty-seventhethicscommitteesshallretainallrecordsrelatingtothecompletionofclinicaltrialsforatleast10years.Thesixthchapteristheresponsibilityoftheapplicant
Article38Thesponsorisresponsibleforinitiating,application,organizationandmonitoringofclinicaltrialsandtheauthenticityofclinicaltrials,responsibleforreliability.Thesponsorisusuallythemedicaldeviceproductionenterprise.Thesponsorforoverseasinstitutionsshallinaccordancewiththeprovisionswithintheterritoryofthepeople'sRepublicofChinaappointedagent.
Article39ThesponsorisresponsiblefororganizingtheformulationandrevisionoftheHandbook,theclinicaltrialsprotocol,informedconsent,casereportform,thestandardoperatingproceduresandotherrelevantdocumentsandisresponsiblefororganizingthetrainingofclinicaltrialsnecessary.
Article40thesponsorshouldaccordingtothecharacteristicsofmedicalapparatusandinstrumentsusedfortesting,intheaccreditationofmedicalinstrumentclinicaltrialinstitutionselectionmechanismtestandresearchwere.Thesponsorbeforetheclinicaltrialagreementsignedinclinicaltrialinstitutionshallclinicaltrialinstitutionsandresearcherstoprovidethelatestresearchmanualandotherrelevantdocuments,foritsdecisionwhethertheycanaffordtheclinicaltrials.
Article41themanualshallincludethefollowingmaincontents:(a)theapplicant,researchersofinformation;(II)testsummaryofmedicaldevicesfor;(III)supporttestmedicaldevicesexpectedoverviewoftheuseandclinicaltrialdesigninreasonandevaluation;and(IV)testwithmedicaldevicemanufacturingwithsuitablemedicalequipmentqualitymanagementsystemrequirementsofthestatement.
Articleforty-secondtheapplicantintheorganizationofthedevelopmentofclinicaltrialsprogrammaynotexaggeratethemechanismandefficacyofmedicaldevices.
Article43inclinicaltrials,thesponsortogetimportantinformationaboutclinicaltrialsshallmodifytheHandbookofresearchandrelateddocumentsintime,andthroughtheclinicaltrialinstitutionofmedicalinstrumentclinicaltrialmanagementdepartmentssubmitethicsreviewcommitteeagreed.
Forty-fourththeapplicantshouldwithclinicaltrialinstitutionsandresearcherstoreachawrittenagreementonthefollowingissues:(a)clinicaltrialimplementationinaccordancewiththerelevantlawsandregulationsandtheclinicaltrialprogram,andaccepttheinspection,verificationandinspection;(two)accordingtothedatarecordingandreportingprocedures;(three)retainthebasicdocumentsandtestthelessthanlessthanthestatutorytime,clinicaltrialsandresearchinstitutionsarenolongerneedtonoticeuntilthesponsorofthedocumentssofar;(four)theapplicantfromtheethicscommitteeapproval,medicalequipmentisresponsibletotheclinicaltrialinstitutionsandresearcherstoprovidetest,anddeterminetheconditionsoftransportandstorageconditions,storagetime,periodofvalidity;(five)testofmedicaldevicesshouldbequalified,itiseasytoidentify,thecorrectencodingandlabeled"test"ofthespeciallogo,andaccordingtotheclinicaltestProgramrequirementsforappropriatepackagingandpreservation;(6)theapplicantshallformulateaclinicaltrialqualitycontrolrelatedSOPs,transportationofmedicaldevicessuchastest,receiving,storage,distribution,processing,recycling,clinicaltrialsresearchorganizationsanddonorfollow.
Article45thesponsortotestwithmedicaldeviceinclinicaltrialsofthesecurityresponsibility.Whenfoundmayinfluencetestimplementationmaychangetheethicscommitteeapprovaltestcontinuesto,thesponsorshallimmediatelynotifyallclinicaltestingmachinestructureandstudytheirsafetyortest,andmakecorrespondingprocessing.
Article46thesponsordecidedtosuspensionorterminationoftheclinicaltrials,itshallnotifyallclinicaltrialinstitutionofmedicaldeviceclinicaltrialmanagementdepartmentin55days,andexplainthereasonsinwrittenform.Clinicaltrialsclinicaltrialsofmedicaldevicesmanagementdepartmentshalltimelynotifythecorrespondingresearchandethicscommittee.Thesuspensionofclinicaltrials,withouttheconsentoftheethicscommitteeandshallnotresume.A
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