임상시험연구 교과기반 학습성과 평가

Abstract

Objectives The purpose of this study is to evaluate the awareness of ethical perspective and clinical research coordinator's roles in an entry-level clinical trial research course based on the course-embedded assessment tied with the program learning outcomes of the bachelor's degree among nursing students.
 Methods Three professional clinical coordinators affiliated with Korea National Enterprise for Clinical Trials (KoNECT) and two nursing professors developed the course based on Good Clinical Practice guidelines in clinical trials. Eighty-three nursing students enrolled and completed this course. Three evaluation criteria were rated in the course-embedded assessment: Completion of the course by getting certificate from the KoNECT(70%), attendance (10%), reflection journal report (20%). Additionally, learners responded two surveys on the satisfaction with education and awareness of ethical roles in clinical trial research. Data were analyzed using the SPSS 23.0 program. The difference in ethical awareness of clinical trial research according to general characteristics was analyzed using t-test and ANOVA with Scheffé's multiple comparison. Importance-Performance analysis(IPA) and thematic analysis were used for ethical perspective and the clinical research coordinator's roles.
 Results All students completed the clinical trial research course by getting the KoNECT certificates, and 94% of students reported that they were satisfied with the course. IPA analysis showed that nursing students recognized all the ethical roles of clinical trial research nurses as more important and more performing. Thematic analysis exhibited that the roles of CRC had four main themes: expertise and responsibility as clinical trial specialists, decision-making based on ethical principles, sufficient education and explanation for the voluntary participation of subjects, and the convergent capability underlying clinical trial research.
 Conclusions Based on these findings, the entry-level clinical trial research course was useful for developing awareness of ethical roles and CRC's roles, and provided a new opportunity to map out nursing students' career path.