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臨床試験等の推進や研究活動において活躍する専門的人財に対する支援―日本臨床試験学会(JSCTR)認定GCP エキスパート® 取得者の意識調査―
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JPY
Abstract
Background The contributions of highly experienced experts are key to conducting clinical trials efficiently and successfully. From 2011 to 2021 the Japanese Society of Clinical Trials and Research(JSCTR)certified 198 Good Clinical Practice(GCP)Experts who met the relevant criteria. However, GCP Experts’ attitudes have never been investigated and their expectations never clarified. We aimed to survey GCP Experts’ attitudes and to take measures to help these experts to contribute to the academic activities of JSCTR. Methods We used team discussions to design a questionnaire form, which JSCTR Certification System Committee members then helped us to finalize. We sent the questionnaire to 180 GCP Experts and received responses from 112(62.2%). We proposed advice and recommendations for JSCTR in accordance with the survey results. Results The motivation for 98 respondents (87.5%)to obtain GCP Expert certificates was self‒enlightenment. Respondents illustrated their ideal model of a GCP Expert by using free‒form input, which we classified into categories such as“leadership”,“ highly experienced”, “knowledgeable”, and“good at teaching”. Sixty‒three respondents(56.3%)said they needed JSCTR’s support to build a platform for information sharing among GCP Experts. Potential types of JSCTR support for GCP Experts would be preparing social‒networking platforms and offering key roles in JSCTR’s academic activities to GCP Experts. Conclusions We surveyed GCP Experts’ attitudes. The Experts were motivated toward self‒enlightenment and needed information sharing with other experts. Increasing the opportunities for GCP Experts to collaborate and interact with each other should help them to work more efficiently and productively.
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