日本呼吸器学会雑誌第44巻第8号

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ときなちゃわんや
4 years ago
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3 Fig. GCPauditbytheO ficeofconformityauditofthepmda.

4 Fig.2 RepresentativeGCPreview report Table Thenumberoftotalinvestigationalsiteswhichcarriedoutclinicaltrialsfornew drugapplications(ndas)and thenumberofcasereportforms(crfs)whichconformedwiththenew GCPinFY24.TheclassificationofmedicalinstitutionsandthesupportingconditionsoftheclinicaltrialsbySiteManagementOrganization(SMO)arecompared. Thenumberofclinicaltrials(applicationmaterials)inFY24was29.ThetotalnumberofCRFs(basismaterials)was 7,547.Thetotalnumberofmedicalinstituteswherenew drugsasinvestigationalproductsforndasinfy24were usedinphasei,i,and Iclinicaltrialswas2,29(thesamesitecanbecountedmorethanonce) Classificationof medical institutions Total numberof investigational sites thesites supported bysmo % Totalnumber ofcase reportforms asbasis materials casereport forms supported bysmo % NationalHospital 79.%,79.% NationalUniversityHospital 372.% 2,72.% PublicUniversityHospital % % PrivateUniversityHospital % 2, % PublicHospital %, % PrivateHospital % 5,94, % Clinic % 3,933,7 44.8% Total 2, % 7,547 3,42 9.5%

5 Table2 Typicalnew GCPissuesconcerningtheheadsofmedicalinstitutions,IRB,investigators,andsub-investigators bydomesticon-sitegcpreviewsatselectedmedicalinstitutionsinfy24.infy24,thenumberofselectedinvestigationalsitesvisitedbygcpauditstafwas,and4institutionalsitesconductedclinicaltrialswhichconformed withthenew GCP(thesamesitecanbecountedmorethanonce) Typicalnew GCPissuesconcerningtheinvestigationalsitesetc.,raisedbytheon-siteGCPauditinFY24 Article3 Contractforclinicaltrial Article28 Compositionofinstitutionalreview board Article3 Continuingreview etc Article32 Responsibilitiesofinstitutionalreview board Article4 Prematureterminationetc.ofclinicaltrial Otherarticles Incompletecontractdocument Incompletecontractdocumentaboutsub-investigators IRBmemberinterestedinthemedicalinstitution etc. Inadequateoperationoftheboardmeeting Failuretoadequatelyandaccuratelyrecordboardmeeting IncompleteIRBSOP Inadequatereview ofadversedrugreactionsthatareboth seriousandunexpectedetc. Incompletereview documentforirbmeeting Inadequatereview process Nowritingnotificationdocumentfrom IRB Delayofthereportofadversedrugreactionsfrom thesponsor Total 29-,29-2,39-2,4-4,and43-etc. * New GCPindicatesMHLW MinisterialOrdinanceNo.28datedMarch27,997andNo.datedJune2,23. institutions

6 Table3 Typicalnew GCPissuesconcerningCRFsbydomesticon-siteGCPreviewsatselectedmedicalinstitutionsin FY24.Thetotalnumberoffindings(includingfindingsconfirmedwiththeformerGCP)onon-siteGCPauditsatthe medicalinstitutionswas89.thenumberofcrfs,crfssupportedbycrc,andcrfswithoutcrcdeficienciesinthe new GCPwas,585,,2,and325,respectively Typicalnew GCPissuesconcerningCRFsraisedbytheonsiteGCPauditinFY24 findings n/,585 CRFs supported bycrc n/,2 CRFs without CRC n/325 Article4 Item 2 Missingrecords(medicalrecords) Missingrecords(examinationslips) 27.%.7% 4.%.% 3.% 4.% Article44 Deficienciesininclusioncriteria Deficienciesinexclusioncriteria 2 3.8%.9% 4.5%.%.8% 4.9% Misconductintheuseofinvestigational products 4.9% 3.%.3% Misconductregardingprematuretermination 4.3% 2.2% 2.% Article4 Item Deviationofdrugsortreatmentinthe clinicaltrials 34 2.% 3 2.5% 3.9% Failuretoperform labtest 4 8.9% 58 4.% % Deviationfrom thelabtestscheduleetc. 9.2% 4.% 5.5% Otherdeviation 28.8% 24.9% 4.2% Deviationintherecords(drugsusedin theclinicaltrials) 9 4.4% % % Article47 Item Deviationintherecords(labtest) Deviationintherecords(ADR) 9 7.2%.% 9 4.7%.% 3 3.%.9% Otherdeviation 9.2% 5.2% 4.2% Article48 Failuretoreportseriousadverseevents Item 2 etc. 3.2%.% 2.% Article5 Item Incompleteinformedconsent 9.% 9.7%.% Article54 Item 3 Norevisionoftheinformedconsent.4%.% 5.5% Other Articles.4%.%.8% Total % % % * TheformerGCPindicatesthedomesticGCPinJapanbeforeharmonizationwithICH-GCP.

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