J Korean Soc Clin Pharmacol Ther. 2012 Dec;20(2):182-194. Korean.
Published online Dec 31, 2012.
Copyright © 2012 Korean Society for Clinical Pharmacology and Therapeutics
Original Article

Results of 2012 KoNECT Certification Program of the Human Resource Project

Sook Jin Seong,1,2 Mi-sun Lim,1 Suna Oak,3 Joomi Lee,1,2 Sung Min Park,1,2 Jeonghyeon Park,1,2 Jeong Ju Seo,1,2 Hae Won Lee,1 Sang-Goo Shin,3 Min Soo Park,3,4 and Young-Ran Yoon1,2,3
    • 1Clinical Trial Center, Kyungpook National University Hospital, Daegu, Republic of Korea.
    • 2Department of Biomedical Science, Kyungpook National University Graduate School, Daegu, Republic of Korea.
    • 3KoNECT, Korea National Enterprise For Clinical Trials, Republic of Korea.
    • 4Department of Clinical Pharmacology, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
Received November 22, 2012; Revised December 10, 2012; Accepted December 14, 2012.

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.

Keywords
Clinical trial professionals; Certification program of the human resource; Physician investigator; Clinical research coordinator; Clinical research associate

Figures

Figure 1
The number of clinical trials approved in Korea (KFDA, 2011).

Figure 2
Comparison of the evaluation results between groups.

Figure 3
The reasons for application. 1: Improvement of the task, 2: Opportunity for employment, 3: Identify for the level of knowledge 4: Recommendation of institution, 5: Etc.

Figure 4
The preferred number of examination per year.

Figure 5
The level of difficulty of the certification examination.s

Tables

Table 1
Qualifications for application

Table 2
General characteristics of applicants (n=220)

References

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    1. Korea Food & Drug Administration, National Institute of Toxicological Research. Clinical trial researchers - specialized materials for participants in clinical trials. 2008.
    1. Park MS. In: Enforcement of the proposed clinical trial professionals certification scheme. 2011.
    1. KoNECT Press release. [last visited on 21 November 2012].

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