임상약리학회지 (Journal of Korean Society for Clinical Pharmacology and Therapeutics)

대한임상약리학회 (Korean Society for Clinical Pharmacology and Therapeutics)
권호 표지

한국 임상연구코디네이터의 담당업무와 시험자가 인식하는 적절업무

Current Tasks and Appropriate Tasks of Clinical Research Coordinators in Korea

  • 투고 : 2011.09.28
  • 심사 : 2011.12.23
  • 발행 : 2011.12.30
⟨ 이전 논문 다음 논문 ⟩

초록

Background: This study was aimed to investigate current tasks done by clinical research coordinators (CRCs) and appropriate tasks of CRCs perceived by investigators, and to classify tasks for CRCs into four categories such as standard, recommended, considered and limited tasks. Methods: The participants were 533 CRCs and 114 investigators who have employed CRCs. Data were collected with self-administrated questionnaire including general characteristics and 32 possible tasks of CRCs from August to November, 2010. Data was analyzed using SPSS win (version 18.0) with descriptive statistics. Results: There were 24 tasks being done by more than half of CRCs, and 15 tasks by more than 75 % of CRCs among 32 possible tasks. The most common task done by CRCs was 'collecting data based on the protocol' and the next was 'scheduling of subjects'. More than half of investigators perceived that all tasks but budgeting appropriate to be done by CRCs, and 18 tasks by more than 75 % of investigators. 13 tasks were classified as standard tasks, 14 as recommended tasks, four as considered tasks, and one as limited task. Conclusion: Standard and recommended tasks for CRCs in Korea have been drawn based on the current tasks done by CRCs and appropriate tasks of CRCs perceived by investigators. It is recommended that investigators utilize this results when they delegate tasks to CRCs and appropriate educational programs could be provided so that CRCs perform standard and recommended tasks proficiently.

키워드

과제정보

연구 과제 주관 기관 : 보건복지부

참고문헌

  1. Bowen K, Rice L. Who is a clinical research nurse? Establishing guidelines and standards of practice for a growing profession. Res Nurse, 1998;4(4):1-4.
  2. Fedor CA. A trend in nursing. Monitor, 2009:23(5):19-21.
  3. Davis AM, Hull SC, Grady C, Wilford BS, Henderson GE. The invisible hand in research : The study coordinators' critical role in human subjects protection. J Law Med & Ethics, 2002;30(3):411-419. https://doi.org/10.1111/j.1748-720X.2002.tb00410.x
  4. Fedor CA. The coordinator's forum part 16: CRCs and CRAs creating a united front to promote integrity in research. Clin Res, 2004;4(5):24-25.
  5. Whalen MD, Fedor C. Clinical research coordinators: Careers and trends. Monitor, 2005; 19(4):23-25.
  6. Kang HS, Kim WO, Jeong IS, Baik JM. The working conditions and clinical trial practice of Research nurses. J Kor Clin Nurs Res, 2004;9(2):41-55. (Korean)
  7. Jeong IS, Kang HS, Kim WO, Kim SY, Baik JM. Jeong SK, Kim HJ, Yang HJ, Kim YH, Choi JY, Shin IS, Shin MJ. The working conditions, job satisfaction and intention to turnover among clinical research coordinators. J Kor Assoc of Clin Res Coordin, 2009;3(1):14-21. (Korean)
  8. Ocker BM, Plank DM. The research nurse role in all clinic-based oncology research setting. Cancer Nurs, 2000;23(4):286-292. https://doi.org/10.1097/00002820-200008000-00005
  9. 신상구. 국내 신약개발 임상 인프라. 제 1회 신약.의료기기개발.임상시험분과 심포지움 자료집, 서울, 2010:59-75.
  10. 정인숙. 임상시험 질확보 및 일자리 창출을 위한 CRC 운용에 대한 현황분석 및 운용전략 연구. 국가임상시험사업단, 서울, 2010.
  11. Adams J. The role of research nurse. Nurs Times, 1994;90(36):70-72.
  12. Saunders C. Job description and performance evaluations. Res Nurse, 1999;5(6):1-22.
  13. Ehrenberger HE, Lillington L. Development of a measure to delineate the clinical trials nursing role. Oncol Nurs Forum, 2004;31(3):E64-E68. https://doi.org/10.1188/04.ONF.E64-E68
  14. Tomomo O, Hiroyuki F, Masahiro U, Mariko H, Kenichi M. Current status understanding and education contents analysis with the aim of constructing education system for clinical research coordinator. Jpn J Clin Pharmacol, 2008;39(5):181-186. https://doi.org/10.3999/jscpt.39.181
  15. Association of Clinical Research Professionals (ACRP). CRC certificate guide.http://www.acrpnet.org/PDF/CRC_Guide.pdf [Online] (last visited on 28 September 2011).
  16. Fisk B, Beier J. Study nurses in Deutschland. Pflege, 2007;20(5):293-299. https://doi.org/10.1024/1012-5302.20.5.293
  17. 전현희. 피험자 동의도 안 받고 진행되는 무감독 임상시험(보도자료). http://www.withjeon.net/IceCream/board.php?ice_code=s2_2&mode=view&bbs_no=221[Online] (last visited on 9 December 2011).