随着信息技术的发展,电子化逐渐成为临床试验数据管理的主要模式。在电子化数据管理条件下,临床试验的数据呈现“动态”的过程,传统的“静态”质量控制方法不能适应这一过程。在临床试验电子化数据管理实践的基础上,建立“试验前-试验中-试验后”全过程的质量控制模式。该模式通过对临床试验的全部环节进行动态质量控制,最大限度地消除了临床试验的偏倚因素,提高临床试验的质量和效率。 With the development of information technology, electronic has gradually become the main mode of clinical trial data management. Under the condition of electronic data management, the data of clinical trials show a “dynamic” process, and the traditional “static” quality control methods can not adapt to this process. On the basis of the practice of electronic data management in clinical trials, a quality control mode of “whole process before test - test - after test” is established. The model through the dynamic control of all aspects of clinical trials, to minimize the bias of clinical trials to improve the quality and efficiency of clinical trials.