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Original Article

The Role of Clinical Research Nurses at Regional Clinical Trials Centers

Journal of Korean Academy of Nursing Administration 2010;16(3):348-359.
Published online: September 30, 2010

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Correspondence: Do, SeonJu, Medical Department, Janssen Koream LS Yongsan Tower, Hangangno 2-ga, Yongsan-gu, Seoul 140-702, Korea. CP.: 82-11-9577-3100, dooo80@snu.ac.kr
• Received: September 15, 2010   • Revised: September 27, 2010   • Accepted: September 28, 2010

Copyright © 2010 Korean Academy of Nursing Administration

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  • Purpose
    This study aimed to evaluate the performance of Clinical Research Nurses (CRNs) and the importance of their roles at the Regional Clinical Trial Centers (RCTCs).
  • Method
    A questionnaire focused on the role of CRNs was crafted by a researcher and the content validity was verified by a panel of experts on clinical research. The subjects of this study were 91 CRNs and Clinical Research Coordinators (CRCs), who were Korean registered nurses working at nine RCTCs. 77 subjects yielded valid data were analyzed using descriptive analysis, the Mann-Whitney U test, Spearman's rank order correlation coefficient, and Kruskal-Wallis test.
  • Results
    The performance of CRNs and the recognition in the importance of their roles were statistically significant different in age, education, CRN careers, positions, employment status and the phase of clinical trial. The role of direct caregiver was performed most often by CRNs. The role of coordinator of care and research (pre-study) was considered the most important role but performed the least frequent.
  • Conclusions
    The role of CRNs can easily be differentiated from CRCs who are not registered nurses. The domains of CRNs should be clearly identified and established. Moreover, research should be carried out on CRN training programs to cultivate competence in CRNs.
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Table 1
The general characteristics of the experts (N=9)
jkana-16-348-i001.jpg
Table 2
The characteristics of the Regional Clinical Trials Centers(RCTCs) (N=9)
jkana-16-348-i002.jpg
Table 3
The demographic characteristics of the subjects (N=77)
jkana-16-348-i003.jpg
Table 4
The work-related characteristics of the subjects(1) (N=77)
jkana-16-348-i004.jpg
Table 5
The work-related characteristics of the subjects(2) (N=77)
jkana-16-348-i005.jpg

BE test: Bioequivalence test, PMS: Postmarketing Surveillance

Table 6
The difference between performance and importance of four roles
jkana-16-348-i006.jpg
Table 7
The correlation between performance and importance of four roles
jkana-16-348-i007.jpg

Figure & Data

References

    Citations

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    • Role Performance and Related Factors of the Clinical Research Coordinator
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    J Korean Acad Nurs Adm. 2010;16(3):348-359.   Published online September 30, 2010
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    The Role of Clinical Research Nurses at Regional Clinical Trials Centers
    The Role of Clinical Research Nurses at Regional Clinical Trials Centers

    The general characteristics of the experts (N=9)

    The characteristics of the Regional Clinical Trials Centers(RCTCs) (N=9)

    The demographic characteristics of the subjects (N=77)

    The work-related characteristics of the subjects(1) (N=77)

    The work-related characteristics of the subjects(2) (N=77)

    BE test: Bioequivalence test, PMS: Postmarketing Surveillance

    The difference between performance and importance of four roles

    The correlation between performance and importance of four roles

    Table 1 The general characteristics of the experts (N=9)

    Table 2 The characteristics of the Regional Clinical Trials Centers(RCTCs) (N=9)

    Table 3 The demographic characteristics of the subjects (N=77)

    Table 4 The work-related characteristics of the subjects(1) (N=77)

    Table 5 The work-related characteristics of the subjects(2) (N=77)

    BE test: Bioequivalence test, PMS: Postmarketing Surveillance

    Table 6 The difference between performance and importance of four roles

    Table 7 The correlation between performance and importance of four roles

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