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.