Kang Hyun Sook, Son Haeng Mi, Lim Nan Young, Cho Kyung Sook, Kwon Sung Bok, Yi Yeo Jin, Park Young Sook, Lee Eun Hee, Kim Joo Hyun, Han Hye Ja, Baik Jung Mi, Jeong Younhee
College of Nursing Science, East-West Nursing Research Institute, Kyung Hee University, Seoul, Korea.
J Korean Acad Nurs. 2012 Dec;42(7):1027-38. doi: 10.4040/jkan.2012.42.7.1027.
This study was done to analyze the job of clinical research coordinators (CRCs).
Through the "developing a curriculum (DACUM)" workshop, the definition of CRCs' role was described and CRCs' duties and tasks were identified. Finally, the developed duties and tasks were validated for importance, difficulty, and frequency.
A CRC is defined as the one who coordinates and performs tasks related to clinical research/trials among investigators, participants, and sponsors according to the Good Clinical Practice at institutions conducting clinical trials. Twelve duties and 78 tasks were identified on the DACUM chart which represented the importance, difficulty, and frequency of tasks represented as A, B, and C respectively. Based on determinant coefficient (DC) of the task, the highest ranked task was confirming the eligibility of participants for research (DC=8.03) and the lowest was inventory management for clinical study materials (3.95).
In this study, the job of a CRC was analyzed through the DACUM process and it was found that CRCs were doing various duties and tasks. Based on these results, it is suggested that it is necessary to develop CRC education programs considering the career ladder of CRCs.
本研究旨在分析临床研究协调员(CRC)的工作。
通过“开发课程(DACUM)”研讨会,描述了CRC的角色定义,确定了CRC的职责和任务。最后,对所制定的职责和任务在重要性、难度和频率方面进行了验证。
CRC被定义为在进行临床试验的机构中,根据良好临床规范,在研究者、参与者和申办者之间协调并执行与临床研究/试验相关任务的人员。在DACUM图表上确定了12项职责和78项任务,分别用A、B和C表示任务的重要性、难度和频率。根据任务的决定系数(DC),排名最高的任务是确认参与者的研究资格(DC = 8.03),最低的是临床研究材料的库存管理(3.95)。
在本研究中,通过DACUM流程分析了CRC的工作,发现CRC承担着各种职责和任务。基于这些结果,建议有必要根据CRC的职业发展阶梯制定CRC教育计划。