临床试验中病例报告表的设计

:(2006CB504602):,[e-mail],[phone]õ循证医学与中医õ万　霞　杨　红　刘建平(北京中医药大学循证医学中心,北京市北三环东路11号,100029)[](CRF),,CRFCRFCRF,CRF[];;(casereportform,CRF)(ICH)(GCP),CRF:,[1],CRF,CRFCRFCRF,CRF1CRF[1]1.1　遵循临床试验方案CRF,CRF,CRFCRF,,,CRF,CRF,,,CRF,,,,CRF,,[2]CRF,,,,,CRF,,,,CRF,1.2　易于理解,方便填写CRF,,,,,,,CRF,,CRF,(),CRF,,CRFCRF,??,,,,?,,1.3　便于数据录入和统计分析CRF,,,,CRF,,,CRF:88520074810JournalofTraditionalChineseMedicine,2007,Vol.48,No.10,,(,CRF);,,2CRF[24],CRF,CRF:(1):,:():(2):CRF,CRF(3):,,,,(4)/:CRF,(5):,()(6):(7)/:(8):(),(9)/:/,,,,(10)::/,:,,(11)(,,)(12):()(13)(14)()(15)(16)(17)CRF(CRF)3CRFCRF,:/,3.1　数值变量,,CRF,,:õ,,,CRF,CRF,,CRF,CRF,CRF,,:õmmol/LLgCRF3.2　分类变量CRF,,,,,,,,:1.2.3.4.;1.:,2.:,3.:,4.:,,88620074810JournalofTraditionalChineseMedicine,2007,Vol.48,No.10,:?,,,,:?,?,,,,:1.2.,,,1212,3.3　日期/时间变量/CRF,,,,,,//,////,2/5/19982552,/,CRF3.4　文本变量CRF,,,CRF,,CRF4CRFCRF,,:(1)CRF,,,CRF,,,[5],CRF,,CRF[6](2)CRF:?,,,,,CRF(3)CRF:CRF,,(4)[5]:,,,,:?,,?,,,,(5)CRF,,,CRF;(6):CRF,,[7],,CRF,CRF,/,5CRF[5]CRFCRF,;,,;,,,CRF[1]ICHHarmonisedTripartiteGuideline:GuidelineforGoodClinicalPractice:3.[2]PatrickMurphy.CRFdesignanddatamanagement.[3]RichardKR,SheilaAV,ColinFW.Clinicaldatamanage-ment(2ndedition).JohnWiley&Sons,LTD.2000:5371.[4]..,2001:116.[5],,,..,2000,17(3):188191.[6],,,..,2007,16(5):339343.[7],..,2005,20(10):620623.[8]GerhardFortwengel.Guideforclinicaltrialstaff:implement-inggoodclinicalpractice.Karger.2004:32.(:2007-08-20)88720074810JournalofTraditionalChineseMedicine,2007,Vol.48,No.10