关键词: 多中心临床试验, 协作单位, 组织管理, MISPS-TCM 项目

Abstract: Selection of cooperative unit directly influences the progress and quality of clinical trial, so the lead group or responsible unit must strictly monitor.Selecting cooperative unit must consider such aspects as the origin, regionalism and race of subjects, related results of clinical epidemiologic survey, the quantity of cooperative unit required, the condition of cooperative unit to be selected, the attitude to this study of cooperative unit, and so on. The organization and management to cooperative unit must be reinforced and the problems appeared during practice must be dealt with in time, for example, adjusting some cooperative unit, thinking highly of the role of sub-centers, monitoring cooperative hospitals and so on.

Key words: multicenter clinical trial, cooperative unit, organization andmanagement, MISPS-TCM Program