中国药房2018，Vol.29Issue(7)：869-872,4.DOI:10.6039/j.issn.1001-0408.2018.07.02
PDCA法在药物临床试验机构新专业资格认定中的实践
Practice of PDCA Method in the New Specialties Accreditation of Drug Clinical Trial Institution
摘要
Abstract
OBJECTIVE:To explore the effects of PDCA method in the new specialties accreditation of drug clinical trial institution. METHODS:PDCA method was used for drug clinical trial institution office and 9 newly applied majors in our hospital. Total score of each major were compared before and after intervention,in order to make the newly applied major meet the standard of specialties accreditation of drug clinical trial. RESULTS:After conducting PDCA related training,establishing new specialties accreditation work group,formulating work goals and plans,9 new majors of our hospital were all approved by CFDA for new specialties accreditation;after intervention total score of each accreditation item for newly applied major were all higher than before intervention,with statistical significance(P<0.05),improved by more than 45.57%. CONCLUSIONS:It is feasible to adopt PDCA method in the preparation of new specialty accreditation of drug clinical trials. It is of significance to guarantee scientific and reliable drug clinical trial results and protect the rights and interests of the subjects.关键词
PDCA法/药物临床试验机构/新专业资格认定Key words
PDCA method/Drug clinical trial institutions/New specialties accreditation分类
医药卫生引用本文复制引用
马丽萍,蒋向明,刘冰,赵同香,王宏宇,向平超,王海英..PDCA法在药物临床试验机构新专业资格认定中的实践[J].中国药房,2018,29(7):869-872,4.基金项目
国家重点研发计划(No.2017YFC0113005) （No.2017YFC0113005）
