J Korean Soc Clin Pharmacol Ther.  2012 Dec;20(2):182-194.

Results of 2012 KoNECT Certification Program of the Human Resource Project

• Seong SJ
• Lim MS
• Oak S
• Lee J
• Park SM
• Park J
• Seo JJ
• Lee HW
• Shin SG
• Park MS
• Yoon YR

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.

Keyword

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

MeSH Terms

Certification
Cytidine Triphosphate
Humans
Korea
Quality Improvement
Surveys and Questionnaires
Silanes
Cytidine Triphosphate
Silanes

Figure

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

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  Figure 2 Comparison of the evaluation results between groups.

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  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.

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  Figure 4 The preferred number of examination per year.

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

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