药物临床试验机构信息化管理平台、质控体系建设情况探究

Research on the Construction of Information Management Platform and Quality Control System of Drug Clinical Trial Institutions

本文主要针对药物临床试验机构信息化管理平台、质控体系建设情况展开研究,先提出医院药物临床试验信息管理现状,然后对药物临床试验机构信息化管理平台的构建与实施进行阐述,主要包括基于网络的医院信息资源共享平台、加强一体化建设、临床试验检测电子申请单系统,最后对药物临床试验机构的质控体系建设要点进行详细论述,主要包括成立专职的质量控制小组、严格执行标准作业程序、加强试验药物的管理等,旨在进一步完善质控体系,并将信息化管理平台的应用价值充分发挥出来,将药物临床试验机构的发展推向全新的高度。

This paper mainly studies the construction of information management platform and quality control system of drug clinical trial institutions.Firstly,this paper puts forward the current situation of hospital drug clinical trial information management,and then expounds the construction and implementation of information management platform of drug clinical trial institutions,mainly including hospital information resource sharing platform based on network,strengthening integrated construction and electronic application form system for clinical trial detection,Finally,the key points of the quality control system construction of drug clinical trial institutions are discussed in detail,mainly including the establishment of a full-time quality control team,the strict implementation of standard operating procediure and the strengthening of the management of experimental drugs,in order to further improve the quality control system,give full play to the application value of the information management platform,and push the development of drug clinical trial institutions to a new height.