临床试验中的病例报告表

11(200001)2131415161123456(CaseReportForm)CRF,,,,CRF,,,,CRFCRF,,CRF,(,),CRF,CRF,,CRF,,,CRFCRF,CRF,(),,11,,:;,;;CRF,21,,,,,,CRF31,,,:1Kgcm(Yes)(No),,,:,,:,,,,,?,,,,::88120006173,,:,,:;,(Matrixpresentation)ADL(ActivitiesofDailyLivingScale):,?,?(1),(2),(3),(4),(9)(1)(2)(3)(4)(9)a1b1c1d1t141,,:+++++++:,;++:;+++:,,:(+):1050(++):51100(+++):100ADL,,,,ADL,ADL51CRF,,,61,,:1860,95mmHg,CRF,186095mmHg,CRF,71CRF,,CRF,,CRF,CRF,,,,,,CRF,CRF,,11(Titlepage),,,,,,21,;;,,,,;CRF,,31,,,(,,),,,:981ChineseJournalofHealthStatistics,June2000,Vol.17,No.312345/33,:7259;143,305(),CRF41CRF,:11186521(HAMD18)312121118652131105mmHg30CRF51(0),EKGCT,,,1012/L109/Lmmol/L(-,+,++,+++)GCP,,,,,,,,61CRF,,,,,CRF,,CRF,,71:,,:,,(),(),81,,,,91,,CRF101,,,,,,,,,,111CRF,,CRF09120006173,CRF,:1121,()31,,,11.,1999.21.,1999.31ICH.E9StatisticalPrinciplesforClinicalTrials.1998.41FDA.DocketNo97D-0188.InternationalConferenceonHarmonisa2tion,DraftGuidelineonGeneralConsiderationsforClinicalTrials.Availi2bility,1997.51A.Spriet,Th.Dupin-Spriet.GoodPracticeofClinicalDrugTrials.2nded.Karger.London.1997.61EleanorMcFadden.ManagementofDatainClinicaltrialsNewYork.JohnWileyandSons,1998.71ICH.E10ChoiceofControlGroupinClinicalTrials.1999Kappa(226002),,,,,,,Kappa,1997152947020490237394725752911529,470,37,Pa=(470+37)/529=01958=472/529490=43712=57/52939=412Pe=(43712+412)/529=01835Pa,Pa=/Pe,21Kappa:Kappa=(Pa-Pe)/(1-Pe)=(01958-01835)/(1-01835)=0174531Sk=1(1-01835)529{01835+(01835)2-472490(472+490)+5739(57+39)}(529)3=0104541KkKappaH0:K=0,H1:K0,=0105U=k/Sk=16156U0101=2158P0101,=0101H0,H1K0KappaKappa,,Kappa01Kappa,,,Kappa0175,,Kappa014,Kappa01745,,Kappa0175,,,,,,21Kappa,,,,31Kappa,,,11..:,1993,446-449.191ChineseJournalofHealthStatistics,June2000,Vol.17,No.3