中国临床药理学杂志Issue(23)：2354-2356,3.DOI:10.13699/j.cnki.1001-6821.2015.23.025
药物临床试验机构办公室项目管理和质量控制能力建设探讨
Exploration of project management and quality control of drug clinical trial institution office
摘要
Abstract
In recent years, the level of the drug clinical trials has been developed rapidly, but the overall level still have some gaps compared with the international mutual recognition, there are still many problems in project management, quality control and other aspects.Our hospital is building a clinical trial platform in line with international standards under the support of the National science and technology major projects for“major new drugs Innovation and development”.This paper summarizes the measures and experiences for project management as well as quality control of drug clinical trial institution office in our hospital.关键词
药物临床试验机构办公室/项目管理/质量控制Key words
drug clinical trial institution office/projectmanagement/quality control分类
医药卫生引用本文复制引用
项玉霞,黄志军,阳国平,袁洪..药物临床试验机构办公室项目管理和质量控制能力建设探讨[J].中国临床药理学杂志,2015,(23):2354-2356,3.基金项目
国家“重大新药创制”科技重大专项、重大疾病新药临床评价研究综合技术平台建设基金资助项目 （）
