摘要
目的:探讨研究者发起的临床研究管理流程缺陷及优化对策,健全内部管理和支撑服务保障,以期提升医院管理能力,保证研究质量,保护受试者权益。方法:以《医疗卫生机构开展研究者发起的临床研究管理办法》的要求和医院药物临床试验的管理细则为标杆,从管理规范、立项管理、过程管理、结项管理4个方面进行全流程对标分析。结果:研究者发起的临床研究在医院逐年增长,医院已出台相关管理文件来保证研究的顺利开展,但是仍存在项目立项审批耗时过长、管理缺乏主动性、研究者和管理人员专业性不足、部分管理环节缺失等问题。结论:增强部门间的协调、制定完整的标准化操作流程、建立信息系统等措施可以优化研究者发起的临床研究的管理,提升研究质量。
Objective:To identify the defects of the management process of investigator initiated trials and explore the countermeasures,improve internal management and support service guarantee,hoping to improve hospital management ability,ensure research quality and protect the rights and interests of subjects.Methods:Benchmarking analysis was carried out from four aspects:management norms,project management,process management,and project closing management.Results:The number of investigator initiated trials has increased year by year in the hospital.The hospital has issued relevant management documents to ensure the smooth development of the research.However,there are still many defects such as long period for project approval,lack of initiative in management,insufficient capability of investigators and managers,and absences of some management steps.Conclusion:Measures such as strengthening coordination between departments,formulating complete standardized operating procedures,and establishing information systems can optimize the management of investigator initiated trials and improve the quality of research.
作者
巫蓉
陆婷婷
胡丹
朱珠
WU Rong;LU Ting-ting;HU Dan;ZHU Zhu(Nanjing First Hospital,Nanjing Medical University,Nanjing 210006,China;Nanjing Medical University,Nanjing 211166,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2022年第14期1402-1406,共5页
Chinese Journal of New Drugs
基金
国家自然基金项目(72104111)
江苏省高校哲学社会科学研究基金项目(2020SJA0289)
南京医科大学哲学社会科学发展专项资助项目(2021ZSZ005)。
关键词
研究者发起的临床研究
对标分析
全流程管理
investigator initiated trial
benchmarking analysis
whole process management
