临床试验辅助管理系统的设计与初步实践

在临床试验的实施过程中,电子化管理可有效实现规范有效的管理以及质量控制并提高工作效率和水平,但国内目前相关电子管理系统的应用较少。为此,本临床试验机构自主研发了一个“临床试验辅助管理系统”,应用计算机网络和数据库技术初步实现临床试验的电子化管理。本文阐述了该系统中研究者信息管理、项目管理、标准操作规程管理等三大功能模块的设计要点及其应用,并就系统的深入开发利用进行了探讨。

Design and preliminary implementation of the CTAM (Clinical Trials Assistant Management)system

Electronic management system can help to accomplish normalization management and quality control of clinical trials significantly,as well as improve efficiency and levels. However domestic electronic management systems are applied rarely by far. In this respect, our clinical trials institution has developed a Clinical Trials Assistant Management System (CTAM) independently, and implement the electronic management for clinical trials based on internet and database technology preliminarily.This article described main points and application of the three function modules in the system,including researcher information management, project management and standard operating procedure management.In the end,further development and application of the management system are discussed.