Abstract
Background
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 certification examinations and questionnaire survey are presented.
Methods
Data including the examination results and questionnaire 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 certification 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.
References
1. KFDA Press release. last visited on 21 November 2012. http://www.kfda.go.kr/index.kfda?mid=56&seq=16432&cmd=v. [Online].
2. Korea National Enterprise For Clinical Trials (KoNECT). Current state of clinical trials in Korea. last visited on 21 November 2012. http://www.konect.or.kr/bbs/board/boardView.action?bbsId=19&thisPage=1&searchField=&searchWord=&bcId=1127 [Online].
3. Kim KH, Kim KS, Choe B, Kim YI. The study of education and qualification for the maintenance of clinical research associate (CRA) professionalism. J Korean Soc Clin Pharmacol Ther. 2011. 19(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. J Korean Soc 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. J Korean Soc 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. Korea Food & Drug Administration, National Institute of Toxicological Research. Clinical trial researchers - specialized materials for participants in clinical trials. 2008.
8. Park MS. Enforcement of the proposed clinical trial professionals certification scheme. 2011.
9. KoNECT Press release. last visited on 21 November 2012. Available from; http://www.konect.or.kr/bbs/board/boardView.action?bbsId=2&header=07&sub=02&bcId=1335&thisPage=1&searchField=&searchWord= [Online].
10. KoNECT. last visited on 21 November 2012. Available from; http://www.konect.or.kr/bbs/board/boardView.action?bbsId=1&bcId=1254&thisPage=6&searchField=bcTitle&searchWord= [Online].