摘要
中医单病种诊疗方案的临床研究在干预措施、效应指标、研究对象等方面均存在研究质量保证的难点,给随机对照试验设计基本原则的落实带来困难。数据管理系统的多用户设计,将承担不同研究任务的研究者分为5种,分配不同的操作权限,有效保证了隐蔽分组和盲法原则的体现。多用户设计策略可用于多种技术模式的数据管理系统平台,具有可推广性。
There are some difficulties in intervention measure, effect index and study object during the quality control of traditional Chinese medical clinical trial for single disease. So it is difficult to follow the fundamental of clinical trial design. The multi -user design on data management system define five researchers according to the different study task, and the different user has different operation power. Then allocation concealment and blind can be insured. The muhi - user design can be used on different data management system based on different technology, and should be popularized.
出处
《中华中医药学刊》
CAS
2011年第9期2052-2053,共2页
Chinese Archives of Traditional Chinese Medicine
基金
浙江省中医药重点项目研究计划(2009ZA004)
关键词
中医临床研究
中医单病种
数据管理
设计
Traditional Chinese Medical Clinical Trial
Single Disease in Traditional Chinese Medical
Data Manage-ment
Design
