Ⅰ期临床试验的信息化管理系统应用

Application of information management system for phase Ⅰ clinical trial

Ⅰ期临床试验涉及到的健康受试者、试验药品、生物样本是试验过程中最需严格管理的关键因素,直接关系到临床研究的质量。在严查临床研究数据的新形势下,如何保证研究数据的真实性、规范性及完整性是临床试验的关键所在。信息化管理系统为提高临床试验效率和质量提供了有力的保障。本文就我院试验常用的信息化管理系统应用进行总结。

Healthy subjects,test drugs and biological samples are the key factors in phase Ⅰ clinical trial,they are directly related to the quality of the trial. Under the new situation of strict check of clinical research data,how to ensure the authenticity,standardization and integrity of research data is the key to clinical trials. The information management system provides a powerful guarantee for improving the efficiency and quality of clinical trials. Therefore,we summarized the application of the commonly used information management systeminourhospital.