临床试验机构评价信息平台功能设计  

Design of Information Platform for Clinical Trial Organization Evaluation

作　　者：张钟元 赵志霞 王欣[3] 商朴 刘丽宏 郭珉江[1] ZHANG Zhongyuan;ZHAO Zhixia;WANG Xin;SHANG Pu;LIU Lihong;GUO Minjiang(Institute of Medical Information,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100020,China;Clinical Trial Research Center,China-Japan Friendship Hospital,Beijing 100029,China;Clinical Trial Center,Beijing Institute of Geriatrics/Beijing Hospital,Beijing 100730,China;Office of National Drug/Medical Device Clinical Trial Institution,Fuwai Hospital,Chinese Academy of Medical Sciences,Beijing 100037,China)

机构地区：[1]中国医学科学院/北京协和医学院医学信息研究所,北京100020 [2]中日友好医院药物临床试验研究中心,北京100029 [3]北京医院/国家老年医学中心临床试验研究中心,北京100730 [4]中国医学科学院阜外医院/国家药械临床试验机构办公室,北京100037

出　　处：《医学信息学杂志》2025年第2期81-86,共6页Journal of Medical Informatics

基　　金：中国医学科学院医学与健康科技创新工程项目。

摘　　要：目的/意义探索建立临床试验机构评价信息系统,为评价工作提供信息化、智能化平台。方法/过程设计以数据采集、数据审核、数据中心及模型配置为核心功能模块的信息平台,为临床试验机构评价提供智能化平台及有效质控、分析工具。结果/结论信息平台基本实现临床试验机构评价流程和评价数据管理信息化,为评价体系落地实施奠定基础,为类似平台建设提供借鉴。Purpose/Significance To explore the establishment of a system for evaluating clinical trials and clinical trial organizations,and to provide an information-based and intelligent platform for evaluation work.Method/Process The paper designs an information platform with data filling,data auditing,data center and model configuration as the core functional modules,providing an intelligent information platform and effective quality control and analysis tools for the evaluation work of clinical trial organizations.Result/Conclusion The information platform basically realizes the informatization of the evaluation process and evaluation data management of clinical trials and clinical trial institutions,lays the foundation for promoting the implementation of the evaluation system,and helps to promote the digitization of the entire evaluation workflow.

关 键 词：临床试验 临床试验机构评价 信息平台 

分 类 号：R-058[医药卫生]