Hao Peng, Wu Linda, Liu Yanfei
Clinical Department, WuXi MedKey Med-Tech Development (Shanghai) Co., Ltd, Shanghai, China.
Linda Wu Consulting, Independent Research Consultant, Loma Linda, CA, USA.
J Res Nurs. 2022 Mar;27(1-2):82-98. doi: 10.1177/17449871211067963. Epub 2022 Apr 1.
The clinical trials industry in China has enjoyed robust growth; the demand for qualified personnel to conduct clinical trials with higher quality has increased. The Clinical Research Nurse has emerged as a new workforce in China.
This study aimed to examine the current work status of Clinical Research Nurses in China and to investigate their competencies in knowledge and behavior associated with this profession.
An online survey was analyzed. The current work status of Clinical Research Nurses in China was characterized. In addition, their competencies were self-assessed across nine competency categories and the "contribution to science" domain, based on the International Association of Clinical Research Nurses Scope and Standards of Practice.
A total of 638 eligible questionnaires were included in the final analysis. Of whom, 98.28% (627/638) were females. The mean age was 35 years (range: 22-64 years). Over 80% of whom were working at the largest Chinese cities and the majority (78.2%) held a Bachelor's degree in nursing. The average time of clinical research experience was 5.67 years. Three quarters of the 638 had an annual income of <150,000 Yuan RMB. The average weekly working time was 45.46 h; clinical trial-related work accounted for 62.68% of their workload. There were some gaps between the Clinical Research Nurses' self-assessed competencies in knowledge and behavior, with the widest gaps along the ethical principles, leadership and professional development, protocol compliance, and document management categories.
This is the first large-scale survey of Clinical Research Nurses in China. Our results profile this emerging workforce as a population of young, moderately trained/experienced, predominantly female nurses working in the largest Chinese cities. They performed well on most knowledge/behavior parameters; still, gaps exist. Therefore, there is a pressing need to enhance professional education and training for Clinical Research Nurses in China.
中国临床试验行业发展迅猛；对高素质人员开展更高质量临床试验的需求与日俱增。临床研究护士已成为中国一支新兴的专业队伍。
本研究旨在调查中国临床研究护士的当前工作状况，并探究其在该专业相关知识和行为方面的能力。
对一项在线调查进行分析。描述了中国临床研究护士的当前工作状况。此外，基于国际临床研究护士协会的实践范围和标准，他们对九个能力类别以及“对科学的贡献”领域的能力进行了自我评估。
最终分析纳入了638份合格问卷。其中，98.28%（627/638）为女性。平均年龄为35岁（范围：22 - 64岁）。超过80%的人在中国最大的城市工作，大多数（78.2%）拥有护理学学士学位。临床研究平均工作年限为5.67年。638人中四分之三的年收入低于15万元人民币。平均每周工作时间为45.46小时；与临床试验相关的工作占其工作量的62.68%。临床研究护士在知识和行为方面的自我评估能力之间存在一些差距，在伦理原则、领导力和专业发展、方案依从性以及文件管理类别方面差距最大。
这是中国首次针对临床研究护士的大规模调查。我们的结果显示，这支新兴的专业队伍是一群年轻、接受过适度培训/有一定经验、主要为女性的护士，在中国最大的城市工作。他们在大多数知识/行为参数方面表现良好；然而，差距仍然存在。因此，中国迫切需要加强对临床研究护士的专业教育和培训。
