构建妇儿专业药物临床试验管理模式

Construction of Professional Medicine Clinical Trial Management Mode for Women and Children

完善的临床试验机构管理体系是保障药物临床试验质量的前提,目前我国还没有公认的完善的药物临床试验质量管理体系。文章通过介绍柳州市妇幼保健院药物临床试验管理模式,旨在进一步规范药物临床试验行为,提高药物临床试验水平,保证临床试验结果科学、可靠,同时为妇儿专业药物临床试验的研究者和管理者提供参考。

Perfect clinical trial organization management system is the premise to ensure the quality of drug clinical trials.At present,there is no recognized perfect quality management system of drug clinical trials in China.This paper introduces the management mode of drug clinical trials in Liuzhou Maternal and Child Health Care Hospital,aiming to further standardize the behavior of drug clinical trials,improve the level of drug clinical trials,ensure the scientific and reliable results of clinical trials,and provide reference for researchers and managers of drug clinical trials of women and children.