中国临床研究护士管理专家共识
Expert consensus on clinical research nurse management in China.
作者信息
Ge Jieying, Liu Yanfei, Gan Bin, Liu Yuhong, Liu Xiaohong, Qiao Jie, Zhao Qing, Chang Ting, Wang Jing, Xing Juying
机构信息
State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou, China.
Fudan University Shanghai Cancer Center, Shanghai, China.
出版信息
Asia Pac J Oncol Nurs. 2023 Jun 5;10(9):100254. doi: 10.1016/j.apjon.2023.100254. eCollection 2023 Sep.
OBJECTIVE
With the rising number of clinical trials conducted in China, the role of Clinical Research Nurses (CRNs) within clinical trial organizations has become increasingly crucial. However, in the absence of industry guidelines, the management of CRNs lacks clarity. This study aims to address this gap by establishing a consensus on CRN management.
METHODS
The IACRN-Shanghai Chapter assembled a panel of experts to develop a consensus on the management of clinical research nurses. This consensus was formulated through an extensive literature review, expert evaluations, and collaborative conference discussions.
RESULTS
The consensus document offers a comprehensive professional definition of CRNs and provides detailed insights into their management. It covers aspects such as job settings, qualifications, responsibilities, training, assessment, workload management, staffing allocation, performance evaluation, and career progression.
CONCLUSIONS
Establishing a professional definition for CRNs creates a standardized reference point for clinical trial institutions to effectively manage these professionals. Consistency in CRNs' roles, training, staffing, and corresponding assessments is essential for promoting their sustainable and healthy development within the field of clinical research.
目的
随着在中国开展的临床试验数量不断增加，临床研究护士（CRNs）在临床试验机构中的作用变得越来越关键。然而，在缺乏行业指南的情况下，CRNs的管理尚不明确。本研究旨在通过就CRN管理达成共识来填补这一空白。
方法
国际临床研究护士协会上海分会组建了一个专家小组，以就临床研究护士的管理达成共识。该共识是通过广泛的文献综述、专家评估和协作会议讨论形成的。
结果
该共识文件提供了CRNs的全面专业定义，并对其管理提供了详细见解。它涵盖了工作设置、资质、职责、培训、评估、工作量管理、人员配置、绩效评估和职业发展等方面。
结论
为CRNs建立专业定义为临床试验机构有效管理这些专业人员创造了一个标准化的参考点。CRNs在角色、培训、人员配备和相应评估方面的一致性对于促进他们在临床研究领域的可持续和健康发展至关重要。
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