Journal of Korean Academy of Nursing Administration (간호행정학회지)

Korean Academy of Nursing Administration (한국간호행정학회)
권호 표지

The Role of Clinical Research Nurses at Regional Clinical Trials Centers

지역임상시험센터 임상연구간호사의 역할 구명

  • Received : 2010.09.15
  • Accepted : 2010.09.28
  • Published : 2010.09.30
Download PDF
⟨ Previous Next ⟩

Abstract

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.

Keywords

References

  1. Carpentier, W. S. (1998). Clinical research nurse career ladder. Res nurs, 4(5), 1-13.
  2. Hong, J. H. (2009). South Korea and Japan comparative study of awareness of the clinical trial, researchers. Unpublished master's thesis, Seoul National University. Seoul.
  3. Hwang, Y. S. (2008). Job analysis of clinical research nurse in oncology department. Unpublished master's thesis, Yonsei University. Seoul.
  4. Jang, I. J. (2006). Modanization of Clinical Trial Infrastructure. J Korean Soc Clin Pharmacol Ther, 14(1), 29-32.
  5. Jung, I. S., Kang, H. S., & Kim, W. O. (2005). Current status of educational experience and preferred educational and certification program of clinical research nurses: A questionnaire survey. J Korean Soc Clin Pharmacol Ther, 13(2), 195-207.
  6. Kang, H. S. (2006). Developing the educational system for clinical trials (II). Korea Food & Drug Administration.
  7. Kang, H. S., Jeong, I. S., Choung, S. Y., Shin, S. G., & Kim, W. O. (2004b). Developing the infrastructure for clinical trial in Korea. J Korean Soc Clin Pharmacol Ther, 12(2), 147-162.
  8. Kang, H. S., Kim, W. O., Jeong, I. S., & Baik, J. M. (2004a). The working conditions and clinical trial practice of research nurses. J Korean Clin Nurs Res, 9(2), 42-55.
  9. Kim, J. S. (2008). Job satisfaction of the clinical research nurse. Unpublished master's thesis, Kyung-pook University. Taegu.
  10. Korea Food & Drug Administration & National Institute of Toxicological Research (2005). Training for clinical trial involved (CRC).
  11. Korea Food & Drug Administration (2008). Korea Good Clinical Practice.
  12. Korea Food & Drug Administration (2008). Bioequivalence Guideline.
  13. Korea National Enterprise for Clinical Trials. http://www.konect.or.kr/
  14. Lee, T. H. (2007, January 3) The government's clinical trials industrialization strategy. Digital Bosa. http://www.digitalbosa.co.kr/
  15. Lynn, M. R. (1986). Determination and quantification of content validity. Nurs Res, 35(6), 382-385.
  16. Park, M. S. (2006, May). The role of RCTC to activate early-phase clinical trials. J Korean Soc Clin Pharmacol Ther - Spring symposium, 2006, 19-24.
  17. Rico-Villademoros, F., Hernando, T., Sanz, J., Antonio López- Alonso, A., Salamanca, O., Camps, C., & Rosell, R. (2004). The role of the clinical research coordinator – data manager- in oncology clinical trials. BMC medical research methodology [On-line], 4(6), http://www.pubmedcentral.nih.gov/
  18. Seoul National University Hospital, Clinical Trials Center (2008). Standard operation procedures. Seoul National University Hospital. Seoul.
  19. Shin, J. Y., Shin, Jo, S. J., Yim, H. W., Jung, H. S., Lee, W. C., Park, Y. J., & Park, Y. M. (2007). Job Satisfaction of Clinical Eesearch Coordinators in a University Hospital. J Korean Soc Clin Pharmacol Ther, 15(1), 57-70.
  20. Shin, S. G., & Jang, I. J. (2001). New drug application process. J Korean Soc Clin Pharmacol Ther, 9(2), 126-137.
  21. Song, S. M. (2008). The recognition of KGCP among CRC in an University Hospital located in Seoul. Unpublished master's thesis, Catholic University. Seoul.