Abstract

Objectives Project-based learning engages students in practical activities related to course contents and has been demonstrated to improve academic performance. Nurses play a particularly important role in promoting clinical trial research as a new professional workforce. An entry-leveled educational course was developed to learn the future professional workforce roles in clinical trial research for nursing students. This study evaluated the effectiveness of a clinical trial research course on the importance and performance of the clinical research coordinators' role, students' recognized achievement, and cooperative self-efficacy.
 Methods Five professional clinical coordinators and two nursing professors developed the four projects on the clinical research processes and roles based on Good Clinical Practice guidelines. Thirteen junior students divided into 4 small groups completed a new project-based clinical research course composed of 8 sessions of clinical field work, discussion, reflection, portfolio, and presentation from September to October 2022. Students responded questionnaires on the importance-performance clinical trial nurses' roles, recognized achievement, and cooperative self-efficacy, and reported the reflective journal on the class. The students' class evaluation data was retrieved and analyzed using importance-performance analysis (IPA) and Wilcoxon signed rank test.
 Results Compared to baseline scores, protocol assessment (z=-2.59, p=.010), protocol planning (z=-1.96, p=.050), and subject recruitment (z=-2.16, p=.031) increased among the 8-section of clinical trial coordinator's roles. Additionally professional role recognition increased after the class (z=-2.25, p=.025). IPA analysis exhibited that nursing students recognized the 8-section clinical trial nurses' roles as more important and more performing. The mean score of nursing students' recognized achievement was high (4.96 points out of 5 points), and cooperative self-efficacy was high (4.37 points out of 5 points) after completing a clinical trial research course.
 Conclusions An entry-leveled educational course on the clinical trial research using project-based learning may expand the possibility of a new professional career for nursing students.

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