药物临床试验机构办公室管理工作实践之沟通

Communication of drug clinical trial institution office management practice

我国药物临床试验必须通过国家食品药品监督管理局和卫生部组织的有资格认定的医疗机构中进行,而药物临床试验机构办公室负责具体管理工作。一项临床试验的顺利实施,不仅需要严格按照方案执行一系列的研究任务之外,也需要机构在试验的全过程中与内部部门和外部单位进行大量的协调工作。因此机构办公室的管理沟通水平与临床试验质量密切相关。

Drug clinical trials in China must be in the State Food and Drug Supervision and Management Bureau and organized by the ministry of health,qualification of medical institutions,and the office of drug clinical trial institution responsible for the specific management. A clinical trial of the smooth implementation,not only need to strictly in accordance with the scheme called for the implementation of a series of research task,also need in the whole process of the experiment with internal departments and external institution done a lot of coordination. Therefore,the level of management communication in institutional offices is closely related to the quality of clinical trials.