医疗器械临床试验信息化管理平台在临床试验管理中的应用  

The Application of Medical Device Clinical Trial Information Management Platform in Clinical Trial Management

作　　者：江欢英 Jiang Huanying(The Affiliated Stomatological Hospital of Nanchang University,Nanchang Jiangxi 330006,China)

机构地区：[1]南昌大学附属口腔医院,江西南昌330006

出　　处：《医疗装备》2024年第18期39-41,46,共4页Medical Equipment

基　　金：江西省卫生健康委科技计划项目(202310625)。

摘　　要：医疗器械临床试验管理中引入数据管理系统后,实现了数据的高效录入及快速处理,有效提升了临床试验管理效率及质量。但临床实践中发现,目前的数据管理系统功能尚不完善,存在数据同步不及时、数据规范性不足、技术创新合理性不足等问题,导致医疗器械临床试验仍面临诸多困境。因此,进一步构建医疗器械临床试验信息化管理平台,完善系统功能,提升信息共享效率势在必行。经实践,构建医疗器械临床试验信息化管理平台后,可提高医疗器械临床试验数据准确性、完整性、有效性,缩短试验周期。因此,医疗器械临床试验信息化管理平台可提高医疗器械临床试验管理水平,推动医疗器械临床试验管理的现代化、信息化发展。After the introduction of data management system in medical device clinical trial management,the efficient input and rapid processing of data were realized,and the efficiency and quality of clinical trial management were effectively improved.However,it was found in clinical practice that the function of the current data management system was not perfect,with problems such as untimely data synchronization,insufficient data standardization,and insufficient rationality of technological innovation,leading to many difficulties in clinical trials of medical devices.Therefore,it is imperative to further establish an information management platform for clinical trials of medical devices,improve system functions,and enhance information sharing efficiency.Through practice,building an information management platform for clinical trials of medical devices can improve the accuracy,completeness,and effectiveness of clinical trial data,and shorten the trial period.Therefore,the medical device clinical trial information management platform can improve the level of medical device clinical trial management,promote the modernization and informatization development of medical device clinical trial management.

关 键 词：医疗器械 临床试验 信息化 管理平台 

分 类 号：R197.39[医药卫生—卫生事业管理]