• Title/Summary/Keyword: Education of persons conducting clinical trial workers

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

  • Lee, Yoon Jin;Jang, Hye Yun;Lee, Yu-Mi
    • The Journal of KAIRB
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    • v.3 no.2
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    • pp.19-27
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    • 2021
  • 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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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) (실시간 비대면 임상시험 종사자 교육(경희대학교병원) 설문 조사 결과 분석을 통한 향후 임상시험 종사자 교육의 지향점과 전망)

  • Kang, Su Jin;Maeng, Chi Hoon;Lee, Sun Ju
    • The Journal of KAIRB
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    • v.3 no.1
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    • pp.11-18
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    • 2021
  • Purpose: The purpose of this study is to investigate a satisfaction survey of untact education and platforms that can be used for untact education to provide recommendations on future development of Education of Persons Conducting Clinical Trials. Methods: Online survey was distributed among students who have taken Untact Education of Persons Conducting Clinical Trials. The result was separated according to topic and descriptive statistics was used for analysis. The satisfaction survey used 10-point scale. Results: Of the 1,720 students who received the survey, 1,347 (78.3%) responded to the lecture satisfaction survey. The satisfaction level for broadcasting program (Kakao TV), an untact educational platform for the education of clinical trial workers at Kyung Hee University Medical Center, was relatively high with 8.09±1.99 points. Average score respondents recommending Kyung Hee University Untact Education of Persons Conducting Clinical Trials was 8.03±1.83 and customer recommendation score (Net Promotor Score) was 27.1%. Satisfaction level of the preferred training time was divided into weekday-morning (8-11 AM) (8.16±1.75), weekday-afternoon (12-4 PM) (7.73±2.07), weekday-evening (5-9 PM) (7.78±2.22), and weekend-morning (9-11 AM) real-time untact education (8.48±1.76) and analyzed. There was a noticeable difference between weekend-morning and weekday-afternoon (p<0.0001) and weekend-morning and weekday-evening (p=0.0001) real-time untact education. When asked about conducting education after COVID-19 pandemic ends, 79.2% (1,012 of 1,279) of the respondents answered that they prefer real-time untact education while 20.8 % (266 of 1,279) preferred face-to-face education. Conclusion: Online education, without time and space constraint, is expected to be the mainstream market in Korea for Education of Persons Conducting Clinical. Kyung Hee University Untact Education of Persons Conducting Clinical has achieved above average satisfaction using Kakao TV. Kyung Hee University Real-time Untact Education of Persons Conducting Clinical Net Promotor Score is 27.1%, which is above industry average, communication with trainees should be considered to improve Net Promotor Score.

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