摘要
为确保研究者发起的临床研究(Investigator-Initiated Trials,IIT)的规范化实施,增强管理效能,医院设计并建设临床研究信息化管理系统(Clinical Research Management Systems,CRMS),其包括3大功能模块,涵盖IIT项目全部管理流程,实现多类别项目一体化高效、准确、留痕的审查模式,系统之间的互联互通和数据的集成整合,临床研究质量的中心化动态监管,数据的实时分析和决策指导以及必备文件的电子化归档。CRMS保障了IIT项目的合法、合规性,提升了临床研究的效率和质量。
In order to ensure the standardized management of investigator-initiated trials(IIT),and improve the management efficiency of IIT,hospital designed and constructed the clinical research information management sys⁃tem(CRMS).This system had three function modules and covered the whole management processes of IIT.On CRMS,an efficient,accurate and traceable verification mode of different clinical trial projects has been implemented;The interconnection and integration of data between systems has been implemented.The central and dynamic supervision of research projects has been implemented.Real-time data analysis has been implemented to instruct managers and researchers in decision-making.The electronic archiving of necessary documents has been imple⁃mented.The application of CRMS ensure the legitimacy and compliance of IIT,and enhance the efficiency and quali⁃ty of clinical research.
作者
张卿
朱天翼
宣淼
董宁欣
吴晓芬
高源
张力
Zhang Qing;Zhu Tianyi;Xuan Miao(Tongji Hospital of Tongji University,Shanghai,200065,China;不详)
出处
《中国医院管理》
北大核心
2023年第4期70-73,共4页
Chinese Hospital Management
基金
国家自然科学基金专项项目(J2024002)
上海申康医院发展中心研究型医师创新转化能力培训项目(SHDC2022CRS048)
上海市医院协会医院管理研究基金项目(X2022041)。
