摘要
研究型医院开展的临床研究项目越来越多。通过对研究型医院开展的临床研究进行包括立项前、实施中、结题后等多角度、全流程的质量控制,可以及时识别临床研究中存在的风险或潜在风险因素,实时评估并解决质量问题,避免发生重大临床研究问题的可能性。研究型医院通过全流程质控过程中及时主动发现问题,确立协调机制、优化沟通流程,减少研究项目质量问题的发生,持续完善临床研究的质量管理体系,保证研究合规、数据完整准确,提升研究结论的可靠性。
More and more clinical research projects are carried out in research hospitals.Through the multi-angle and whole-process quality control of the clinical research conducted by the research hospitals,including pre-project establishment,implementation,and post-completion,it can timely identify risks or potential risk factors in the clinical research,evaluate and solve quality problems in real-time,and avoid the possibility of major clinical research problems.Through whole-process quality control,research hospitals identify problems timely and proactively,establish coordination mechanisms,optimize the communication process,reduce the occurrence of research project quality problems,continuously improve the quality management systems of clinical research,ensure that research is compliant,data is complete and accurate,as well as improve the reliability of research conclusions.
作者
王晶
程金莲
董杰昌
WANG Jing;CHENG Jinlian;DONG Jiechang(Ethics Committee Office,Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China;Office of Human Research Protection Programs,Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China;Beijing Aging Association,Beijing 101117,China)
出处
《中国医学伦理学》
北大核心
2024年第5期514-519,共6页
Chinese Medical Ethics
基金
北京市医院管理中心2021年北京市属医院科研培育计划项目“中医医联体模式下临床研究HRPP体系建设及效果评估”(PG2021019)
首都医科大学2023年教育教学改革研究课题“中医临床方法学与流行病学混合式教学模式课程建设”(2023JYY323)
2021年度北京中医药大学教育科学研究课题“中医药临床专业学生科研伦理素养提升研究”(XJY21108)。
关键词
研究型医院
临床研究
质量控制
流程管理
伦理审查
research hospital
clinical research
quality control
process management
ethical review
