摘要
为提升我国药物临床试验监管水平,改变监督管理方式、有效控制临床试验过程中的风险、提升新药研发过程中的科学性、安全性、时效性,本院配合研发了药物临床试验质量管理规范信息化监管系统,同时自主研发了机构内药物临床试验机构管理系统。通过建设该系统,搭建多层信息平台,提供全过程动态临床试验信息管理与分析、综合评价、监督管理等功能,更进一步完善临床试验信息化管理体制、机制和组织体系,提高临床试验整体管理和操作水平。
To enhance the level of clinical trial supervision in our country, and change the way of supervision and management to effectively control the risk in the process of clinical trial, and promote science, safety and efficiency in the process of new drug research and development. The drug clinical trials with GCP information supervision system were researched and developed in our hospital, at the same clinical trial institution management system （CTIMS） was created. Multilayer information time, the drug platforms were structured through the construction of CTIMS, which could provide whole process dynamic supervision, management of clinical trial information management, analysis of comprehensive evaluation, and other functions. The management system and organization system, information management system of clinical trial were further perfected. And the overall clinical trial management and operation levels were improved.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2016年第5期339-345,共7页
Chinese Journal of New Drugs and Clinical Remedies
基金
十一五"重大新药创制"科技重大专项课题(2009ZX09301008-007-014)
十二五"重大新药创制"科技重大专项课题(2013ZX09303001)
