臨床研究コーディネーターの熟達度評価尺度の開発

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  • Development of a Scale that Evaluates the Level of Expertise of Clinical Research Coordinators

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<p>Background: There is a lack of information to create an effective instruction strategy for clinical research coordinators (CRCs). This study aimed to develop a scale that evaluates the level of expertise of CRCs.</p><p>Methods: The original scale was developed including 96 items based on items reviewed by several researchers and the results of a pilot survey. The original scale was distributed to 12 CRCs who attended a training program at an academic society to investigate its test-retest reliability. The original scale was also distributed to another group of CRCs at medical institutes or site management organizations in order to perform exploratory factor analysis and confirmatory factor analysis.</p><p>Results: The interclass correlation coefficient of the whole scale was 0.957 through the first survey of 12 CRCs. Exploratory factor analysis by the maximum-likelihood approach with promax rotation indicated 4 factors, i.e., knowledge, attitude, management skill and basic, from 90 items. Cronbach's α of the whole scale was 0.984, and those of the subscales were 0.943〜0.979. Regarding fit indexes, chi-square value was 35732.138 (p<0.01), Goodness of Fit Index (GFI) was 0.449, Adjusted GFI (AGFI) was 0.423, and Root Mean Square Error of Approximation (RMSEA) was 0.091 from the results of confirmatory factor analysis.</p><p>Conclusion: The scale that evaluates the level of expertise of CRCs that we developed is reliable and valid although there was an issue regarding fitness of the model.</p>

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  • 臨床薬理

    臨床薬理 50 (5), 221-227, 2019-09-30

    一般社団法人 日本臨床薬理学会

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