研究护士在临床试验全程管理中的作用

    The Role of Study Nurses in the Whole-Process Management of Clinical Trials

    • 摘要: 研究护士是随着临床试验行业发展而产生的一种职业,目前大多数的医院没有专人全程管理临床试验项目,导致临床试验质量无法得到保证。作为国内最早借鉴国外先进经验启用研究护士及落实相关研究护士制度的医院之一,本文总结十几年来研究护士参与临床试验全程管理实践及取得成效,供同行参考。

       

      Abstract: In the development of clinical trials, study nurse is a newly emerging professional that greatly assist investigators to manage the daily and routine jobs of clinical research coordination. However, most of the hospitals have no dedicated personels to help manage clinical trials, resulting in the unguaranteed quality of clinical trials. Drawing on the experience of abroad clinical trial research institutions, Guangdong Provincial People's Hospital is one of the first hospitals that start recruitment of study nurses and implement the participation and regulation system of study nurses. In this study, we summarized the management practice and achievements of the participation of the study nurses in clinical trials over the past ten years for peer reference.

       

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