【摘要】 如何促进新药临床研究的规范化,保障临床研究结果的真实性、科学性,是目前新药临床试验质量管理的重点。笔者总结近几年从事新药临床试验项目管理工作的经验,从法规指南的学习、立项评估、工作团队创建、方案实施的培训、原始数据记录、质量监控、研究协调员的使用及试验药物的管理等方面浅谈做好新药临床试验项目管理的工作体会。更多还原

【Abstract】 How to promote the standardization of new drug clinical researches and guarantee the authenticity and scientificity of the results of clinical studies,is currently the focus of quality management of new drug clinical trials.In this paper,authors summarized the working experience of clinical trial project management in recent years from the points of laws and guide learning,project evaluation,work team creating, implementation training,original data recording,quality control,the use of research coordinator,the management of test drug and so on.更多还原