多中心药物临床试验机构研究护士培训体系的构建

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Construction of training system for research nurses in multicenter drug clinical trial institutions

WANG Jingjing， ZHU Xu， YU Shuyan

Huashan Hospital， Fudan University， Shanghai 200040 China

*Corresponding Author  WANG Jingjing， E⁃mail：821021316@qq.com

Abstract  Objective：To construct a training system for research nurses in multicenter drug clinical trial institutions.Methods：Literature retrieval and analysis were conducted to draft the initial training system for research nurses in multicenter drug clinical trial institutions.Two rounds of expert consultation were carried out，and based on the feedback received，the final version of training system for research nurses in multicenter drug clinical trial institutions was developed.Results：The constructed training system for research nurses in multicenter drug clinical trial institutions included 6 first⁃level indicators（theoretical knowledge ability，professional practical ability，program implementation ability，communication and collaboration ability，overall management ability，professional development ability），19 second⁃level indicators，and 58 third⁃level indicators.The questionnaire return rates for both rounds of expert consultations were 100.00%，with expert authority coefficients of 0.919 for both rounds.The coefficients of variation were ranged from 0.05 to 0.23 and ranged from 0.00 to 0.21，respectively，while Kendall's W were 0.113 and 0.205（both P<0.001）.Conclusions：The constructed training system for research nurses in multicenter drug clinical trial institutions had certain scientificity，innovation，and practicality.

Keywords    multicenter clinical trial; research nurse; Delphi method; training system; nursing

摘要  目的：构建多中心药物临床试验研究护士培训体系。（剩余6616字）