[논문]의약품 임상시험 종사자 교육 이수자의 지식 수준, 태도, 교육 선택 요인 분석

이윤진; 장혜윤; 이유미

[국내논문] 의약품 임상시험 종사자 교육 이수자의 지식 수준, 태도, 교육 선택 요인 분석
An Analysis on the Knowledge Levels, Attitudes, and Factors Affecting the Choices of Those Who Completed the Education of Persons Conducting Clinical Trial Workers 원문보기

The journal of KAIRB = 대한기관윤리심의기구협의회지, v.3 no.2, 2021년, pp.19 - 27

이윤진 (계명대학교 동산병원 임상연구보호센터) , 장혜윤 (계명대학교 동산병원 임상연구보호센터) , 이유미 (경북대학교 의과대학 예방의학교실)

Abstract ▼ AI-Helper

Purpose: This study aimed to analyze the knowledge levels, attitudes, and factors affecting the choices on the education of the participants who completed their education of persons conducting clinical trial workers, and to assess the problems of the current education system for clinical trial workers, leading to improvements. Methods: Clinical trial workers (including principal investigators/subinvestigators, members of the Institutional Review Board [IRB], clinical research coordinators) who were affiliated to one of the 4 university hospitals running their own clinical trial center and IRB in Daegu and completed their education of persons conducting clinical trial workers were the subjects of this study. One hundred seven online questionnaires were answered from 2021-04-02 to 2021-04-17. Descriptive statistics and Pearson correlation analysis were used to analyze the acquired data. Independent t-test and 1-way analysis of variance were used to analyze the differences in the knowledge levels and attitudes following the characteristics of the education participants. Results: The baseline characteristics of the 107 participants were as follows: the majority of the participants were female (72.0%), were in their 30s (36.4%), had a nursing major (29.0%), were clinical research coordinators (63.6%), had never experienced a principal investigator (79.4%), had participated 3 or more educations (58.9%), had completed their maintenance course (55.1%), had 5 or more years of clinical trial experiences (34.6%). The fields on which participants had low levels of objective knowledge were "types and preparations on audits of clinical trials," "regulations on clinical trials (Pharmaceutical Affairs Act, Korea Good Clinical Practice)." The difficulties that the participants faced were on "annual educations" and "lack of information regarding the educations." Factors that showed significant differences in objective knowledge were sex (p=0.02), number of educations (p=0.004), the curriculum of 2020 (p=0.001). Age (p=0.004), having experienced a principal investigator (p=0.006), number of educations (p<0.001), the curriculum of 2020 (p<0.001), clinical trial career (p=0.001) were factors that significantly affected subjective knowledge. Attitudes toward the education were positively correlated with objective knowledge (r=0.20, p=0.04) and subjective knowledge (r=0.32, p=0.001). Major sources through which information on educations was acquired were "institutional notices," and major factors affecting the choices on the education were "when the education took place" and "where the education took place." "Within the affiliated institution," "Online classes (recorded)" and "IRB and review processes" were each the most preferred place, mode, and content of the education. Conclusion: Knowledge levels varied largely among participants who completed their education of persons conducting clinical trial workers, depending on their characteristics such as the number of educations. Participants also complained about their lack of information on educations. The quality of education may be improved if clinical trial organizations are designated as education facilities. Education programs must be developed considering the knowledge level and demand of the participants. Furthermore, as offline classes may be impossible due to pandemics such as the coronavirus disease 2019, the development of diverse and sophisticated online classes is looked forward to.

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참고문헌 (14)

Ministry of Food and Drug Safety, Korea National Enterprise for Clinical Trials. Current status of domestic clinical trials [Internet]. Cheongju (Korea): Ministry of Food and Drug Safety; 2021 May [cited 2021 Jul 28]. Available from: https://www.koreaclinicaltrials.org/kr/contents/datainfo_data_01_tab02/view.do/.
Kim IS. A study on improvements of the present education system for persons conducting clinical trials [thesis]. Seoul: Ewha Womans University; 2018. p. 124.
Education of persons engaged in clinical trials, system supplementation required. Dailymedi [Internet]. 2017 Mar 17 [cited 2021 May 25]. Available from: http://www.dailymedi.com/detail.php?number816860&thread25r01.
Kim JS. An investigation into the IRB members' and investigators' perceptions of Institutional Reivew Boards [thesis]. Seoul: Yonsei University; 2006. p. 83.
Lee GE. Knowledge and attitude of social behavioral researchers on Institutional Review Board (IRB) Review [thesis]. Seoul: Yonsei University; 2017. p. 92.
Regulation: education of persons engaged in clinical trials and designation of Institution offering education on clinical trials of 2019, Article 9 (Online Education) [Internet]. Cheongju (Korea): Ministry of Food and Drug Safety; 2019 Jan [cited 2021 May 25]. Available from: https://www.mfds.go.kr/brd/m_211/view.do?seq14302.
Ministry of Food and Drug Safety. Operational guideline of human research protection program [Internet]. Cheongju (Korea): Ministry of Food and Drug Safety; 2021 [cited 2021 May 24]. Available from: https://www.mfds.go.kr/brd/m_210/view.do?seq12203.
Ministry of Food and Drug Safety. Current status of clinical trial education implementation institution designation [Internet]. Cheongju (Korea): Cheongju (Korea): Ministry of Food and Drug Safety; 2021 Jun [cited 2021 Jul 15]. Available from: https://nedrug.mfds.go.kr/pbp/CCBBQ02.
Kim JY. Analysis of the currently operating educational programs of legally licensed training institutes to set up a Standard Education Program for Clinical Trial Employee in Korea [thesis]. Gimhae (Korea): Inje University; 2018. p. 60.
Kang SJ, Maeng CH, Lee SJ. Future direction and prospect for education of persons conducting clinical trials through survey analysis of real-time untact education of persons conducting clinical trials (Kyung Hee University Hospital). J KAIRB 2021;3:11-8.
Jung IS, Kwon YK, Cho YS, Lee EJ. Research ethics camp and consultation for university students. Final report. Seoul (Korea): National Research Foundation of Korea; 2013. Report No: 2013S1A4A1056171.
Declaration of Helsinki: Article 23 [Internet]. Fortaleza (Brazil): World Medical Association; 2013 Oct [cited 2021 May 25]. Available from: http://www.nibp.kr/xe/info4_5/28325
Regulation: Life Ethics and Safety Act of 2020, Article 10 (Organization and operation of IRB, etc.) [Internet]. Sejong (Korea): Ministry of Health and Welfare; 2020 Sep [cited 2021 May 25]. Available from: https://www.law.go.kr/LSW/lsInfoP.do?efYd20200912&lsiSeq220891#0000.
Seo KH. Development of clinical trial worker's education program - focus on 'clinical research coordinatorr's education program [thesis]. Cheongju (Korea): Chungbuk University; 2019. p. 78.

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[국내논문] 의약품 임상시험 종사자 교육 이수자의 지식 수준, 태도, 교육 선택 요인 분석
An Analysis on the Knowledge Levels, Attitudes, and Factors Affecting the Choices of Those Who Completed the Education of Persons Conducting Clinical Trial Workers 원문보기

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[국내논문] 의약품 임상시험 종사자 교육 이수자의 지식 수준, 태도, 교육 선택 요인 분석 An Analysis on the Knowledge Levels, Attitudes, and Factors Affecting the Choices of Those Who Completed the Education of Persons Conducting Clinical Trial Workers 원문보기

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[국내논문] 의약품 임상시험 종사자 교육 이수자의 지식 수준, 태도, 교육 선택 요인 분석
An Analysis on the Knowledge Levels, Attitudes, and Factors Affecting the Choices of Those Who Completed the Education of Persons Conducting Clinical Trial Workers 원문보기