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논문 기본 정보

자료유형
학술저널
저자정보
정인숙 (부산대학교 간호대학) 최상민 (부산대학교병원 임상시험센터) 윤지향 (부산대학교 간호대학) 윤은화 (부산대학교병원 임상시험센터)
저널정보
대한임상약리학회 임상약리학회지 임상약리학회지 제20권 제1호
발행연도
2012.1
수록면
60 - 73 (14page)

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초록· 키워드

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Background: This study was aimed to investigate the perception on working conditions and utilization of clinical research coordinators (CRCs) among investigators and sponsors. Methods: The participants of this cross-section study were 114 investigators and 138 sponsors including clinical research associates (CRAs) who have worked with CRCs. Data was collected with paper or electronic form of self-administered questionnaires and analyzed with descriptive statistics and ${\chi}^2$ test or t test. Results: Among investigators and sponsors, 56.1% and 95.0% perceived regular full-time positions as proper type of CRC employment, respectively. Those who perceived monthly salary with incentive as proper payment system were 67.5% of investigators and 68.8% of sponsors. The proper salary for 2-year CRCs and 5-year CRCs were significantly higher in sponsors than investigators. Investigators perceived CRCs could handle 3 studies as the same time and 5 studies per year. In regard to the difficulty in utilizing CRCs, 68.4% of investigators perceived lack of experienced CRCs and 84.8% of sponsors did frequent turnover. Those who responded pooling CRCs by hospital or clinical trial centers as a good solution to hire CRCs easily were 81.6% of investigators and 58.0% of sponsors. Conclusion: Almost all investigators and sponsors perceived CRCs were helpful for improving the quality of clinical trials. We recommend each institution or clinical trial centers could introduce the central CRCs' employment and management with proper salary and workload based on the results to maintain experienced CRCs and lessen the turnover of CRCs.

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