Results of 2012 KoNECT Certification Program of the Human Resource Project

국가임상시험사업단 주도 2012 임상시험 전문인력 인증시험 시범사업 시행결과

  • Seong, Sook Jin (Clinical Trial Center, Kyungpook National University Hospital) ;
  • Lim, Mi-Sun (Clinical Trial Center, Kyungpook National University Hospital) ;
  • Oak, Suna (KoNECT, Korea National Enterprise For Clinical Trials) ;
  • Lee, Joomi (Clinical Trial Center, Kyungpook National University Hospital) ;
  • Park, Sung Min (Clinical Trial Center, Kyungpook National University Hospital) ;
  • Park, Jeonghyeon (Clinical Trial Center, Kyungpook National University Hospital) ;
  • Seo, Jeong Ju (Clinical Trial Center, Kyungpook National University Hospital) ;
  • Lee, Hae Won (Clinical Trial Center, Kyungpook National University Hospital) ;
  • Shin, Sang-Goo (KoNECT, Korea National Enterprise For Clinical Trials) ;
  • Park, Min Soo (KoNECT, Korea National Enterprise For Clinical Trials) ;
  • Yoon, Young-Ran (Clinical Trial Center, Kyungpook National University Hospital)
  • 성숙진 (경북대학교병원 임상시험센터) ;
  • 임미선 (경북대학교병원 임상시험센터) ;
  • 옥선아 (국가임상시험사업단) ;
  • 이주미 (경북대학교병원 임상시험센터) ;
  • 박성민 (경북대학교병원 임상시험센터) ;
  • 박정현 (경북대학교병원 임상시험센터) ;
  • 서정주 (경북대학교병원 임상시험센터) ;
  • 이혜원 (경북대학교병원 임상시험센터) ;
  • 신상구 (국가임상시험사업단) ;
  • 박민수 (국가임상시험사업단) ;
  • 윤영란 (경북대학교병원 임상시험센터)
  • Received : 2012.11.22
  • Accepted : 2012.12.14
  • Published : 2012.12.31

Abstract

Backgroung: In recent years, clinical trials have considerably increased and relevant education programs to clinical trials have been developed and implemented since 2008 in Korea. To enhance the quality as well as global competitiveness of clinical trial professionals (CTPs), a certification program of the human resource is needed. Accordingly, in Korea the first and the second certification examinations were implemented in February and October 2012, respectively. In this paper, introduction of the certification program of the human resource is described, and results of the cerification examinations and questionnaire survey are presented. Methods: Data including the examination results and questionaire survey was collected by cooperative officials in Korea National Enterprise for Clinical Trials. Applicants who were selected eligible for examination by the steering committee were asked to complete questionnaires provided with the test papers on the day of the certification examination. Results: In the first certification examination, a total of 221 eligible participants completed the examination. 99.5% of the participants responded the questionnaire survey. In the second examination, a total of 223 applicants participated. The examination consisted of 50 multiple-choice questions with cut-off score of 70 per cent score. 176 & 194 CTPs passed the first & second examinations respectively. Conclusion: This paper that described the results of the two cerification tests and questionnaire surveys might be helpful in establishment and activation of the certification program in the future. Quality improvement of CTPs and international competitiveness of clinical trial in Korea can be anticipated by the certification program.

Keywords

Acknowledgement

Supported by : 보건복지부, 국가임상시험사업단

References

  1. KFDA Press release. http://www.kfda.go.kr/ index.kfda?mid=56&seq=16432&cmd=v. [Online] (last visited on 21 November 2012)
  2. Korea National Enterprise For Clinical Trials (KoNECT). [통계] 한국의 임상시험 현황. http://www.konect.or.kr/bbs/board/boardView.action?bbsId= 19&thisPage= 1&searchField=&sear chWord=&bcId=1127 [Online] (last visited on 21 November 2012)
  3. Kim K, Kim K, Choe B, Kim Y. The study of education and qualification for the maintenance of clinical research associate (CRA) professionalism. J Korean Soc Clin Pharmacol Ther, 2011;I9(2):130-143. (Korean)
  4. Choi N, Kim H, Lee S, Jung S, Kim O, Park K, Park B. Current status and preferred model of clinical trial education and certification program for investigators: A questionnaire survey, Kor J Clin Pharmacol Ther, 2005;13(2):186-194 (Korean)
  5. Jeong I, Kang H, Kim W. Current status of educational experience and preferred educational and certification program of clinical research nurses : A questionnaire survey, Kor J Clin Pharmacol Ther, 2005;13(2):195-207. (Korean)
  6. Park KH, Kim YM, Jang HW, Kim OJ, Park BJ. Current status and preferred model of clinical trial education and certification program for clinical trial pharmacists: A questionnaire survey, Kor J Clin Pharmacol Ther, 2005;13(2): 208-220. (Korean)
  7. 식품의약품안전청, 국립독성연구원. 임상시험 관련자를 위한 전문교재 - 임상시험연구자. 2008.
  8. 박민수. 임상시험 전문인력 인증제도 시행안. 임상개발 역량 강화를 위한 KFDA, KoNECT, KSCD 공동 워크숍 발표 자료, 2011
  9. KoNECT Press release. Available from; http://www.konect.or.kr/bbs/board/boardView.action?bbsId=2&header=07&sub=02&bcId= 1335&thisPage= l&searchField=&search Word= [Online] (last visited on 21 November 2012)
  10. KoNECT. Available from; http://wwwkonect. or.kr/bbs/boardView.action?bbsId= 1&bcld= 1254&thisPage=6&searchField=bcTitle&searchWord= [Online] (last visited on 21 November 2012)