医院临床试验电子档案的特点及优劣势分析

Analysis of the Characteristics,Advantages and Disadvantages of Electronic Archives of Clinical Trials in Hospitals

首先阐明我国临床试验的数据档案处于纸质和电子形式并存的状态,随着临床试验技术和信息技术的不断进步,临床试验的数据管理呈现电子化的发展趋势。然后列举了电子档案及纸质档案的特点,尤其对电子档案在源数据的可溯源性、账号授权及权限、保密性、文件保存等方面的特点加以阐述。从法规要求和便捷性、可行性方面比较电子数据档案与纸质数据档案的各自优劣,电子数据档案拥有更多优势。最后指明阻碍当前电子数据档案推行的难点,为临床试验电子数据档案推行提出建议。

Firstly,the paper points out that the data archives of clinical trials in China are in both paper and electronic state.With the continuous progress of clinical trial and information technology,the data management of clinical trials presents the trend of electronic development.Then the characteristics of electronic archives and paper archives of clinical trials are enumerated,and especially the traceability of source data,account authorization and access,confidentiality,document preservation are discussed.By comparing the advantages and disadvantages of electronic archives and paper archives from the aspects of regulatory requirements,convenience and feasibility,electronic data archives have more advantages.Finally,it points out the difficulties that hinder the implementation of electronic data archives management at present,and puts forward suggestions for the implementation of electronic data archives of clinical trials.