摘要
"共享综合服务"是医院示范性研究型病房开创的一种新型服务模式,旨在通过参与和协调药物/器械临床试验实施的全流程,提高药物/器械临床试验的效率和质量。作者介绍医院示范性研究型病房"共享综合服务"运行模式,重点介绍医院研究型病房的专职研究医生在临床试验中的角色分工与工作流程,详细描述了"共享综合服务"中各个环节的医疗行为;以采用"共享综合服务"模式合作临床试验项目的访视及方案偏离数据为例,强调了专职研究医生对临床试验质量的影响。通过医院示范性研究型病房"共享综合服务"医疗实践,为研究型病房与临床科室合作项目的运行和医疗保障提供依据和参考。
‘Shared Integrated Services’ is a new service model created by the hospital’s exemplary research ward,which aims to improve the efficiency and quality of drug/device clinical trials by participating in and coordinating the entire process of drug/device clinical trials. The author of this paper briefly introduces the operational mode of ‘Shared Integrated Services’, and mainly introduces the role assignment and working process of the full-time research physicians in clinical trials in our research ward, and describes in detail the medical behavior of whole process in ‘Shared Integrated Services’. The impact of full-time research physicians on the quality of clinical trials is highlighted with the example of visits of subjects and protocol deviation data from collaborative projects using a "Shared Integrated Services" mode. This paper provides the basis and reference for the operation and medical security of the cooperation projects of the research ward and clinical departments through the medical practice experience of ‘Shared Integrated Services’.
作者
黄樱硕
汪颖
张健雄
李丽君
陈敬成
孔艳红
董瑞华
HUANG Yingshuo;WANG Ying;ZHANG Jianxiong;LI Lijun;CHEN Jingcheng;KONG Yanhong;DONG Ruihua(Beijing Friendship Hospital,Capital Medical University,Beijing,100050,PRC)
出处
《中国医院》
北大核心
2021年第11期55-57,共3页
Chinese Hospitals
基金
北京市研究型病房建设示范单位项目(BCRW202010)。
