Journal of the Korea Academia-Industrial cooperation Society (한국산학기술학회논문지)

The Korea Academia-Industrial cooperation Society (한국산학기술학회)
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Comparison of the Perceptions between Investigators and Clinical Research Associates in Role Performances of Clinical Research Coordinators

임상연구코디네이터의 역할수행에 대한 연구자와 임상시험모니터요원의 인식비교

  • Ko, Il-Sun (Dept. of Clinical Nursing Science, Yonsei University) ;
  • Hwang, Youn-Sun (Nursing Policy Research Institute, Yonsei University) ;
  • Kim, Ho-Kon (Dept. of Clinical Nursing Science, Yonsei University)
  • 고일선 (연세대학교 간호대학) ;
  • 황윤선 (연세대학교 간호정책연구소) ;
  • 김호곤 (연세대학교 간호대학)
  • Received : 2014.05.22
  • Accepted : 2014.08.07
  • Published : 2014.08.31
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Abstract

The aim of this study was to compare the perceptions of the role performance of a clinical research coordinator (CRC) between the investigators and clinical research associates (CRAs). Data was collected using a structured questionnaire from 39 investigators and 68 CRAs in 4 hospitals from March 7 to November 30, 2011 and analyzed using descriptive statistics and a t-test. The investigators and CRAs were aware of the importance of CRC's role and they all gave the highest values for patients care management. On the other hand, the score of the role performance items showed perceptional differences between investigators and CRAs. Therefore, the development of detailed job descriptions and manuals will be needed to reduce the perceptional differences in the role performance of the CRC.

본 연구는 임상연구코디네이터와 함께 임상시험을 수행하는 연구자 및 임상시험모니터요원이 인식하는 임상연구코디네이터의 역할수행 정도를 비교분석하기 위한 조사연구이다. 본 연구의 자료는 2011년 3월 7일부터 11월 30일까지 4개 병원의 연구자 39명과 임상시험모니터요원 68명을 대상으로 구조화된 설문지를 활용하여 수집하였고, 기술통계와 t-test를 이용하여 분석하였다. 연구자와 임상시험모니터요원 모두 임상시험에서의 임상연구코디네이터의 역할수행이 매우 중요하다고 인식하고 있었고, 그 중에서도 대상자 관리 업무에의 역할 수행 비중이 가장 높다고 인식하고 있었다. 그러나 각 항목별 역할수행 정도에 관해 연구자 집단과 임상시험모니터요원 집단 간 인식 정도를 비교해 보면 차이가 나타났다. 따라서 임상연구코디네이터의 역할수행에 대한 인력 간 인식 차이를 줄일 수 있는 보다 객관적인 임상연구코디네이터의 업무기술 및 지침 개발이 요구된다.

Keywords

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