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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2024, Vol. 29 ›› Issue (4): 455-459.doi: 10.12092/j.issn.1009-2501.2024.04.014

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Investigation and analysis of the current status of clinical research nurses

CHEN Liming1, ZHANG Haiyan2, HUANG Fan3, ZHAO Wenyan1, DING Rui1, CAO Cai4, FANG Yi1   

  1. 1Research Ward of Clinical Trial Institutions at Peking University People's Hospital, Beijing 101109, China; 2Nursing Department of Peking University People's Hospital, Beijing 100044, China; 3School of Pharmacy, Peking University, Beijing 100083, China; 4Zhongguancun Jiutai Drug Clinical Trial Technology Innovation Alliance, Beijing 100081, China
  • Received:2023-12-20 Revised:2024-01-29 Online:2024-04-26 Published:2024-03-25

Abstract:

AIM: To investigate and analyze the current situation and needs of clinical research nurses in China, in order to provide scientific basis for constructing a training system for research nurses, promoting standardized training, and achieving standardized management for them. METHODS: A self-made questionnaire was used to investigate 102 research nurses from nearly 70 well-known clinical trial institutions in China. The contents of the questionnaire mainly included the general information, professional experience and work content of the research nurses, the sense of accomplishment and training needs of clinical trial work. RESULTS: Among the 102 research nurses surveyed, 92.15% have a bachelor's degree or above; 53.92% of those have intermediate or higher professional titles; 74.51% of them are part-time research nurse. Among professional experiences, 19.61% have more than 10 years of clinical trial experience; 47.06%, 40.20%, and 21.17% of surveyed research nurses were authorized to participate in clinical trial drug management, sample management, and quality control; 70.59% of research nurses have a high sense of achievement in their daily work. In terms of education and training needs, clinical trial related laws and regulations, standardized training for clinical trial protocol implementation, and good clinical practice (GCP) are the three most important aspects. CONCLUSION: Clinical research nurses in China have a relatively high level of education and nursing experience, but there is still a large gap in the amount of professional full-time clinical research nurses in China. Due to the rapid development of innovative drugs and devices, as well as the urgent need to improve the clinical research system, it is necessary to establish a training, assessment, and evaluation system for research nurses that is in line with China's national conditions in order to improve the professional level of research nurses, and improve the quantity and quality of clinical trial research on innovative drugs and devices in China.

Key words: clinical trial research, clinical research nurse, training, cultivation

CLC Number: