摘要
《药物临床试验质量管理规范》的实施,对临床试验研究的伦理、科学性、规范化、质量及成果产出等各方面要求日渐提高,临床研究协调员(CRC)在临床研究的规范化实施及质量控制方面的关键作用已被高度肯定,但在国内尚属起步阶段。文中以黑龙江中医药大学中医临床科研项目"国家重大科技专项(慢病项目)"为例,重点就CRC职责、引进、管理及创新等方面进行阐述,旨在为同行同类试验研究提供借鉴,为CRC的体制建设提供参考。
Since the implementation of Good Clinical Practice,the demands are increasing on many aspects of clinical trials,such as ethics,science,standardization,quality and achievement output. The key importance of clinical research coordinator( CRC) has been highly affirmed in the standardization and quality control in clinical research. But it is still in the starting stage domestically. In the paper,by taking TCM clinical research project of National Major Scientific Research Project( Chronic Disease) in Heilongjiang University of Traditional Chinese Medicine as the example,the discussion was especially focused on the responsibility,introduction,management and innovation of CRC,aiming to provide the reference of the trials in the same category and field and benefit the mechanical construction of CRC.
出处
《世界中西医结合杂志》
2016年第2期263-266,共4页
World Journal of Integrated Traditional and Western Medicine
基金
科学技术部国家重大科技专项基金资助项目(201107005)
