中国临床药理学杂志2016，Vol.32Issue(1)：78-80,3.DOI:10.13699/j.cnki.1001-6821.2016.01.025
中外病例报告表中不良事件监测内容差异分析
Analysis of integrity differences of adverse event monitoring in domestic and foreign case report forms
摘要
Abstract
Objective To explore the integrity differences of adverse event(AE) recording in domestic and foreign case report forms (CRFs). Methods Based on Chinese and international good clinical practice (GCP)and relative references, items of AE recording in CRF were de-signed.The recording ratios of every item in domestic and foreign CRFs collected in ethics committee during the past five years were analyzed al-ternately and independently by two researchers .The integrity was com-pared and items with lower recording ratio were discussed .Results Fi-nally104 domestic CRFs and 62 foreign CRFs were enrolled .The recor-ding ratios of duration of AE (58%vs 81%, P<0.05) and relationship to study drug ( 40% vs 54%, P<0.05 ) in domestic CRFs are significantly lower than those in foreign CRFs .While the recording ratio of reporting of serious adverse event (43%vs 26%,P<0.05) in domestic CRFs is stati-cally higher than that in foreign CRFs .The integrity rates of AE type (30%vs 37%,P>0.05) and AE tracking (20% vs 24%,P>0.05) in both domestic and foreign CRFs are very low .Conclusion There are differences of AE recording integrity in both domestic and foreign CRFs . In domestic CRFs , recordings of duration of AE , relationship to study drug, AE type and AE tracking especially should be paidmore attention .关键词
病例报告表/不良事件监测/完整性Key words
case report form/adverse event monitoring/integrity分类
医药卫生引用本文复制引用
徐娜娜,陆瑶,舒婧娴,温改艳,戴海江,阳国平,李莹,袁洪,陈瑞芳..中外病例报告表中不良事件监测内容差异分析[J].中国临床药理学杂志,2016,32(1):78-80,3.基金项目
国家重大新药创制科技重大专项基金资助项目:重大疾病新药临床评价研究综合技术平台建设基金资助项目(2012ZX09303014001) （2012ZX09303014001）
国家自然科学基金资助项目(81273594) （81273594）
"十二五"国家科技支撑计划课题基金资助项目(2012BAI37B05) （2012BAI37B05）
