基于PaaS的临床试验多级质量管理云模式探索  

Research on a PaaS-based quality management system for clinical trials:a multi-level,cloud service model

作　　者：易玲[1] 虞勋[2] 刘亚军[3] 石建[1] 尤晓明[1] 张华[1] 缪丽燕[2] YI Ling;YU Xun;LIU Yajun;SHI Jian;YOU Xiaoming;ZHANG Hua;MIAO Liyan(National Drug Clinical Trial Institution,The First Affiliated Hospital of Soochow University,Jiangsu Suzhou 215000,China;Department of Pharmacy,The First Affiliated Hospital of Soochow University,Jiangsu Suzhou 215000,China;Department of Information,The First Affiliated Hospital of Soochow University,Jiangsu Suzhou 215000,China)

机构地区：[1]苏州大学附属第一医院药物临床试验机构,江苏苏州215000 [2]苏州大学附属第一医院药学部,江苏苏州215000 [3]苏州大学附属第一医院信息处,江苏苏州215000

出　　处：《中国医院药学杂志》2023年第15期1710-1715,共6页Chinese Journal of Hospital Pharmacy

基　　金：国家科技重大专项项目(编号:2017ZX09304021);苏州市临床试验能力提升项目(编号:SLT201914);苏州市科研管理软课题项目(编号:SR202157)。

摘　　要：目的:探索医院临床试验质量管理的数字化发展新模式,提升管理效率、提高试验质量。方法:基于“平台即服务”(下称“PaaS”)模式,采用零代码平台,优化架构、按需设计、部署功能软件,搭建专属的临床试验质量管理轻量型信息系统,形成多层级、实时交互的管理模式。结果:医院临床试验机构成功自主构建上述系统,从试验的“结构(S)-过程(P)-结果(O)”特征进行基于风险的质量管理,形成“项目组-临床科室-机构办”三位一体的临床试验多级管理云模式,使试验各方的相关人员均能通过手机等移动终端实时、快速地了解项目的实施进度并进行沟通,有助于加强科室对临床研究的管理,有序开展、加速入组,落实多级质控,同时强化人员联系、减轻机构工作量、提升管理效力,有效提升项目质量。结论:借助互联网云平台PaaS模式,医院临床试验机构可独立、经济、快速地构建简洁、灵活、适用性强的项目管理信息系统;SPO精简管理有助于快速把控项目风险。该探索为医院管理与临床研究的数字化发展提供了积极借鉴。OBJECTIVE To explore a novel model for digitalization in the quality management of clinical trials in hospitals,in order to enhance management efficiency and improve trial quality.METHODS Based on the"Platform-as-a Service"(abbr.PaaS)architecture,or more precisely,cloud service provided by a zero-code platform in our study,a clinical trial quality management information system was established through structure optimization,on-demand design,and deploying functional software modules.We aim to develop a multi-level management mode with functions of real-time monitoring and convenient interaction through this lightweight system.RESULTS The system mentioned above was successfully developed by fellows in the National Institution of Clinical Trials(abbr.NICT)in our hospital,independently.Then,clinical trials were monitored by the risks according to their quality features of"Structure-Process-Outcome",and a three-level quality oversight mode was constructed by related persons from the project team,the clinical department,and the office of NICT.This setting benefits all parties by allowing them to be aware of the conduct status of a trial quickly and conveniently by cellphone or some other mobile terminals,and communicate online whenever needed.Thus it strengthens the hospital management of clinical trials,esp.in clinical departments,resulting in an orderly and speedy trial implementation.Moreover,the system makes the multi-level quality control pragmatic,while at the same time,reducing the workload of the NICT office and enhancing management efficiency,giving rise to improved quality of clinical trials in hospitals.CONCLUSION Based on the internet cloud service mode of PaaS,the institution of clinical trials in hospitals can independently,economically and quickly establish a simple and flexible information system for clinical research management with strong applicability.The optimized and brief SPO featured method enables quick identification and risk management in a clinical trial.In addition,our research provides meani

关 键 词：临床试验 质量管理 PAAS 云服务 信息系统 多级管控 

分 类 号：C931[经济管理—管理学] R95[医药卫生—药学]