中国药业2025，Vol.34Issue(11)：13-17,5.DOI:10.3969/j.issn.1006-4931.2025.11.004
思维导图结合案例培训法提升临床试验质量控制能力
Improvement of Clinical Trial Quality Control Ability Through Mind Mapping Combined with Case Training Method
摘要
Abstract
Objective To improve the quality control ability of clinical trial quality controllers.Methods A total of 46 quality controllers appointed or authorized by professional departments were selected as the research subjects,and they were randomly divided into the control group and the experimental group,with 23 controllers in each group.The control group took the routine training method,while the experimental group took the mind mapping combined with case training method.The training effect and quality control ability between the two groups was compared through the assessment of knowledge of laws and regulations,case quality control assessment and questionnaires.Results The scores of the assessment of theoretical knowledge of laws and regulations and the assessment of case quality control in the experimental group were significantly higher than those in the control group(P<0.05).The overall quality control ability in the experimental group was higher than that in the control group,and the scores of compliance of the review of experimental plan,judgment of the rationality of inspection results,feedback and tracking of standardized quality control problems in medical records in the experimental group were significantly higher than those in the control group(P<0.05).Conclusion Mind mapping combined with case training is helpful to improve the training effect of quality controllers,so as to improve the quality control ability of clinical trial quality controllers.关键词
思维导图/案例培训/临床试验/质量控制能力Key words
mind mapping/case training/clinical trials/quality control ability分类
医药卫生引用本文复制引用
董晶,王晓璐,王雅琼,周学锋,朱娜..思维导图结合案例培训法提升临床试验质量控制能力[J].中国药业,2025,34(11):13-17,5.基金项目
山东省中医药科技项目[2019-zyy033] （）
山东省青岛市医疗卫生科研项目[2024-WJKY078]. （）
