中国医学装备
中國醫學裝備
중국의학장비
CHINA MEDICAL EQUIPMENT
2012年
4期
46-49
,共4页
临床研究%质量管理%独立第三方%探索
臨床研究%質量管理%獨立第三方%探索
림상연구%질량관리%독립제삼방%탐색
Clinical study%Quality management%Independent third party%Exploration
目的：随着临床研究项目投入的增加,临床研究的质量控制管理逐渐被研究者所重视,寻找适合我国临床研究的质控管理模式成为当务之急。方法：结合临床研究质量管理的实践,阐述临床研究质量管理的重要性。从研究流程、流水线分工及文件化管理等方面分析临床研究质量管理的关键点。结果：对6个临床研究课题的45家参研医院开展4个阶段的现场核查,对比核查前后各课题研究质量,人员合理性由75%提高到95%,伦理批准率由33.3%提高到83.3%,知情同意书（ICF）签署率由68%提高到76%,研究方法一致性由82.2%提高到97.8%,病历报告表（CRF）数据规范性由60%提高到85%,数据来源真实性由90%提高到91.1%,文件存档合理性由66.7%上升到100%。结论：独立三方参与临床研究的质量管理将加强和完善临床研究的科学性、真实性和规范性。
目的：隨著臨床研究項目投入的增加,臨床研究的質量控製管理逐漸被研究者所重視,尋找適閤我國臨床研究的質控管理模式成為噹務之急。方法：結閤臨床研究質量管理的實踐,闡述臨床研究質量管理的重要性。從研究流程、流水線分工及文件化管理等方麵分析臨床研究質量管理的關鍵點。結果：對6箇臨床研究課題的45傢參研醫院開展4箇階段的現場覈查,對比覈查前後各課題研究質量,人員閤理性由75%提高到95%,倫理批準率由33.3%提高到83.3%,知情同意書（ICF）籤署率由68%提高到76%,研究方法一緻性由82.2%提高到97.8%,病歷報告錶（CRF）數據規範性由60%提高到85%,數據來源真實性由90%提高到91.1%,文件存檔閤理性由66.7%上升到100%。結論：獨立三方參與臨床研究的質量管理將加彊和完善臨床研究的科學性、真實性和規範性。
목적：수착림상연구항목투입적증가,림상연구적질량공제관리축점피연구자소중시,심조괄합아국림상연구적질공관리모식성위당무지급。방법：결합림상연구질량관리적실천,천술림상연구질량관리적중요성。종연구류정、류수선분공급문건화관리등방면분석림상연구질량관리적관건점。결과：대6개림상연구과제적45가삼연의원개전4개계단적현장핵사,대비핵사전후각과제연구질량,인원합이성유75%제고도95%,윤리비준솔유33.3%제고도83.3%,지정동의서（ICF）첨서솔유68%제고도76%,연구방법일치성유82.2%제고도97.8%,병력보고표（CRF）수거규범성유60%제고도85%,수거래원진실성유90%제고도91.1%,문건존당합이성유66.7%상승도100%。결론：독립삼방삼여림상연구적질량관리장가강화완선림상연구적과학성、진실성화규범성。
Objective：To identify the quality management model applicable to clinical study in China as the governmental,corporate and social investments into clinical study increases and increasing emphasis is paid on quality management of clinical study by researchers.Methods：The critical quality control points in quality management of clinical study were analyzed in respects of research process,division of labor in the production line and documentation management in combination with practices in quality management of clinical study.Result：Four stages of on-site verification of 45 hospitals involved in six clinical studies are carried out.Comparison of study quality before and after verification shows rationality of human resource assignment increases from 75% to 95%;ethical approval rate rises from 33.3% to 83.3%;ICF signing rate goes up from 68% to 76%;consistency of research method increases from 82.2% to 97.8%;CRF data normativity rises from 60% to 85%,authenticity of source data goes up from 90% to 91.1%;rationality of document archiving increases from 66.7% to 100%.Conclusion：The participation of the independent third party into the quality management of clinical study is to enhance and improve the scientificity,authenticity and normativity.
