Development of Clinical Research Management: Enhancement of Nursing Students' Clinical Competency in Handling Clinical Trials

간호대학생의 임상시험실무역량강화를 위한 '임상연구관리' 교과목 개발

Chu, Sang Hui;Jang, Yeonsoo;Yeo, Ki-Sun;Ahn, Ji Hyeon;Kim, Doo Ree

  • Received : 2014.04.23
  • Accepted : 2014.06.09
  • Published : 2014.08.31


Purpose: The aim of this study was to develop a new course entitled 'Clinical Research Management' to enhance nursing students' clinical competency in handling clinical trials. Methods: The goals and content of the existing current education program for clinical research professionals such as clinical research coordinators and clinical research associates provided by the Korea National Enterprise for Clinical Trials were analyzed to identify the core educational concepts. A focus group interview was performed to investigate essential competency levels for the professionals who were to begin their career in the area of clinical trials after graduating from the college of nursing. Through these initial processes, we identified the core competency required for clinical research professionals and the related course content. Goals and objectives based on the specified four competencies were set and confirmed by expertise review. Results: We developed a new course entitled Clinical Research Management, a 16-week elective subject consisting of various teaching and learning strategies based on four core competencies: basic knowledge on clinical trials, communication, risk management, and ethics. Conclusion: The results of this study will contribute to enhancing nursing students' clinical competency, including knowledge, skills, and attitudes relevant to clinical trials.


Clinical trial;Competency-based education;Nursing students


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