PDCA法在药物临床试验机构新专业资格认定中的实践

摘要

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.%目的:探索PDCA法在药物临床试验机构新专业资格认定中的作用.方法:将PDCA法用于我院药物临床试验机构办公室与9个新申请专业的管理中,比较干预前后各专业评价总分,以使其达到药物临床试验专业资格认定标准.结果:通过进行PD-CA相关培训、建立新专业资格认定工作组、制订工作目标和计划书等工作后,我院9个新专业全部通过国家食品药品监督管理总局新专业资格认定审核,干预后每个新申请专业资格认定项目的评价总分均高于干预前,差异均有统计学意义(P<0.05),平均改善幅度大于45.57%.结论:在药物临床试验新申请专业资格认定准备工作中采用PDCA方法是可行的,该方法在保障药物临床试验结果科学可靠,保护受试者的权益等方面具有重要意义.