电子数据采集(electronic data capture,EDC)可以提高临床试验效率、保障数据质量、缩短研究周期、降低研究成本。随着互联网的普及和临床试验行业对EDC认识的提高,临床试验电子化趋势将不可避免。本文首先介绍了临床试验数据管理的现状及EDC的概念,然后对应用EDC系统带来的益处和面临的困难进行了分析,最后对药品研发者应用EDC系统提供了建议。
Automated generation of a World Wide Web-based data entry and check program for medical applications[J] T. Kiuchi;S. Kaihara Computer Methods and Programs in Biomedicine 1997,
Automated generation of a World Wide Web-based data entry and check program for medical applications[J] T. Kiuchi;S. Kaihara Computer Methods and Programs in Biomedicine 1997,