广东省药学会药物临床试验专业委员会安全评价-广东共识-2016-曹烨

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··〔2016〕86《·》、《·》。。753-2510080020378863263788632137886330gdsyxh45@126.comhttp//.sinopharmacy.com.cn《·》201684·2016201684、。、。。、、。、、、。。、、。73、、。“”、“”。2016630·906·20169269PharmacyToday2016SepVol.26No.9、GCPSOP。。。、adverseeventAE。。1.1-3。3“”“”ad-versedrugreactionADR。、、、。2.3-5seriousadverseeventSAE“”。。。、。。。。。、。。3.13-4severeserious。、。“severe”。“serious”6。“”。4.、46-7、SuspectedUn-expectedSeriousAdverseReactionSUSAR、。、。。。、/、、、、·016·PharmacyToday2016SepVol.26No.920169269。1.28-9。。。/。/。、/。“”12“”。、、。、。2.2468。。“”“”。“”。。3.10-11、。。SOP。4.26、、、。。5.212///。1。CDISCtheClinicalDataInterchangeStandardsConsortiumCDASHClinicalDataAcquisitionStandardsHarmonization“”“”。。“”。。“”“”“”“/”。。“”。2“/”。6.813、、、/“”。7./214-156、、、、·116·20169269PharmacyToday2016SepVol.26No.9、。、、、、、《》。8.216。。。9.317WHO、NCICTCAE。、、NCICTC1~5。。Ⅱ35~310I35~36Ⅱ37~38I39~310。。、/2-31118-19。、。1.、/、/2.KarchLasagna、Naranjo。CFDA“”1。1CFDA++++-++++-++±±-+-、++-±-+-±。3.5“”“”“”“”。4.“”。5.、、、、、、。、、、、。、。。·216·PharmacyToday2016SepVol.26No.920169269、181.、《》。、CRF。CRF。、、、。。、、SOP。2.GCP2420。。。SOP、GCP。。3.“”。4。、//。/。、、、、。1./111//。21。14。“”。、、、。。、。2./1214/2。2/、282862828、1.21-22。·316·20169269PharmacyToday2016SepVol.26No.9“”“”。“”、/、、、。CSclinicalsignificance“”NCSnon-clinicalsignificance“”。。2./4、/。。1/、。2、3。。4、。5、。6。7/。。84、、。IRB。3.1-31ICH。、2243。。·416·PharmacyToday2016SepVol.26No.920169269。、、、、。3。3、、、、~、CRF~、。、1ICHE6R1ICHharmonizedtripartiteguideline.GuidelineforGoodClinicalPracticeEB/OL.http//.gbv.de/dms/bs/toc/350771871.pdf1996-06-10/2016-07-20.2Merck&Co.Inc.AdverseEventReportFormandGuidelinesForNon-seriousandSeriousAdverseEventsRelatedtoRaltegra-virinIMPAACTP1097EB/OL.http//impaactnetwork.org/DocFiles/P1097/P1097AEReportingMerckInstructions05May11.pdf2016-07-20.3NormanM.Goldfarb.AdverseEventTerminologyJ.JournalofclinicalresearchBestpractices201287.4ICHE2AsectionⅡandEdwardsI.R.etalHarmonizationinPharmacovigilanceJ.DrugSafety199410293-102.5CIOMSV/VIReportCurrentChallengesinPharmacovigilancePragmaticApproachesCurrentChallengesinPharmacovigi-lancePragmaticApproachesM.TheCIOMSVWorkingGroupWG2009297-298.6MichaelJ.KlepperBrianEdwards.IndividualCaseSafetyRe-portsHowtoDeterminetheOnsetDateofanAdverseReac-tionJ.DrugSafety2011344299-305.7EuropeanCommissionEnterpriseDirectorate-GeneralDetailedguidanceontheEuropeandatabaseofSuspectedUnexpectedSeriousAdverseReactionsEB/OL.http//ec.europa.eu/health/files/pharmacos/docs/doc2003/april/cp-guidance-eud-ravigilance_160403_en.pdf2003-04/2016-07-15.8S.EricCeh.AdverseEventReportingDuringtheStudyJ.JournalofclinicalresearchBestpractices200958.9CIOMSV/VIGuidelinesforPreparingCoreClinical-SafetyIn-formationonDrugsM.TheCIOMSVWorkingGroupWGSecondEdition1999Chapter36.10ICTDRInvestigatormanualmonitoringandreportingadversee-ventsEB/OL.http//.icssc.org/Documents/Resources/ICTDR_AE_Manual_February_6_2003_final.pdf.2003-02-06/2016-07-19.11H/EPDF.GeneralconsiderationsforclinicaltrialsM.ICHE8200511-2.12CDISCTheClinicalDataInterchangeStandardsConsortium.EB/OL.http//imaging.cancer.gov/programsandre-sources/reportsandpublications/CDISC2004-06-25/2016-07-21.13FDAGuidanceGoodPharmacovigilancePracticesandPhar-macoepidemiologicAssessmentEB/OL.http//.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdf2005-03/2016-07-21.14GuidanceonReviewingandReportingUnanticipatedProblemsInvolvingRiskstoSubjectsorOthersandAdverseEventsM.U.S.departmentofHealth&HumanServices2010.15FDAGuidanceGuidanceforIndustryPostmarketingAdverseEventReportingforNonprescriptionHumanDrugProductsMarketedWithoutanApprovedApplicationEB/OL.http//.fda.gov/Down-loads/Drugs/GuidanceComplianceRegu-latoryInformation/Guidances/UCM171672.pdf2012-06-30/2016-07-21.16FDAGuidanceGuidanceforIndustryandInvestigatorsSafetyReportingRequirementsforINDsandBA/BEStudiesEB/OL.http//.fda.gov/downloads/drugs/guidancecompli-anceregulatoryinformation/guidances/ucm227351.pdf2012-12/2016-07-21.17GayHADykPDeasyJOetal.CommonTerminologyCrite-riaforAdverseEventsCTCAEv4.0BasedHybridPatientandPhysicianQuestionnaireforHeadandNeckHNRadio-therapySymptomReportingJ.Fuel&EnergyAbstracts2011812S673.18.《》81EB/OL.http//.sda.gov.cn/WS01/CL0053/62621.html2011-05-04.19Cobert.BL.Cobert'smanualofdrugsafetyandpharmacovigi-lance/M.Jones&BartlettLearning2010.20.《》3EB/OL.http//.sda.gov.cn/WS01/CL0053/24473.html2003-08-06.21DocumentingClinicallySignificantLabValuesJ.JournalofclinicalresearchBestpractices2009511-4.22NationalMarrowDonorProgramEventReportingTerminologyQuickReferenceEB/OL.https//.cibmtr.org/DataMan-agement/Documents/Event%20Reporting%20Terminology%20Quick%20Reference.pdf2016-07-20.23FDAGuidanceforIndustry.EstablishingPregnancyExposureRegistriesEB/OL.http//.fda.gov/cder/guidance/3626fnl.pdf.2012-08/2016-07-20.·516·20169269PharmacyToday2016SepVol.26No.9

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