药物临床试验机构GCP培训情况分析及改进措施

Analysis and Improvement Measures of GCP Training in Drug Clinical Trial Institutions

摘要: 目的：采用问卷调查的方式对参加GCP培训的学员进行培训效果调研，通过对问卷结果进行收集和整理，分析GCP培训中的教学不足和学员知识掌握的薄弱环节。方法：利用Excel和GraphPad Prism5.0对问卷调查结果的正确率、分数分布等结果进行整理和分析。结果：本次问卷调查共计回收491份问卷，其中有效问卷487份，有效问卷率99.18%。487份问卷中，有87.89%的学员问卷得分在80分以上，仅有2.05%的学员问卷得分不及格。此次培训总体效果良好，但仍存在部分知识点薄弱环节，后期我们将通过优化课程设计，丰富培训形式等措施增加培训的实践性以及互动性，从而进一步提升培训效果。结论：举办相关培训可以有效提高GCP从业人员的理论水平与实践能力，促进GCP事业发展。

Abstract: AIM: Questionnaire survey was used to investigate the training effects of the students who participated in the GCP training. Through collecting and sorting out the questionnaire results, the weak links in the teaching and students’ knowledge mastery in the GCP training were analyzed. METHODS: Excel and GraphPad Prism5.0 were used to analyze the accuracy of the questionnaire results, score distribution and other results. RESULTS: A total of 491 questionnaires were collected, including 487 valid questionnaires, and the valid questionnaire rate was 99.18%. Among the 487 questionnaires, 87.89% of the students scored above 80 points, and only 2.05% of the students failed the questionnaire. Our results showed that the GCP training could substantially improve the quality of personnel of students, whereas there were still some weak links in the knowledge points. Therefore, the course design and training forms should be optimized to increase the practicality and interactivity of the training. CONCLUSION: Relevant training can effectively improve the theo-retical level and practical ability of GCP practitioners, and promote the development of GCP career.