摘要
ARO-CRO合作运行模式可以较好地兼顾ARO的专业性和CRO的执行力,目前多用于管理多中心临床研究。借鉴此方式,中国中医科学院西苑医院临床药理研究所与CRO公司通过组建项目运行管理协作组、建立顺畅的沟通及反馈机制等方式,在方案制定、伦理审查、药品管理、启动培训、质量控制与质量保证、中期会议、数据管理、中心关闭以及结果发表等方面分工协作,共同推进临床试验的顺利开展,为建立符合中药临床研究特色的项目运行管理模式进行有益探索。
Currently,running and managing a multi-center clinical trial by ARO-CRO mode is recommended as it can effectively balance ARO＇s professionalism and CRO＇s execution. Referring to this mode,the institution of clinical pharmacology of Xiyuan Hospital,CACMS,and CRO collaboratively established a project management team,set up an effective communication and feedback mechanism,and collaborated in protocol design,ethical review,medicine management,initiation training,quality control and quality assurance,midterm conference,data management,site close,and result publishing,etc. to push the smooth progress of clinical trials. This mode is a helpful exploration for establishing operation management mode that conforms to the characteristics of clinical research of traditional Chinese medicine.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2016年第7期775-778,786,共5页
Chinese Journal of New Drugs
基金
国家"重大新药创制"科技重大专项(2012ZX09303-010-002)
国家中医药管理局中医药行业科研专项(201207001-02)
中国中医科学院自主选题(ZZ0908022)
关键词
中药临床研究
项目管理
学术研究组织
合同研究组织
TCM clinical research
project management
academic research organization
contract research organization
