中国医疗设备2016，Vol.31Issue(11)：129-132,4.DOI:10.3969/j.issn.1674-1633.2016.11.038
医疗器械临床试验不良事件监控质量调查
Investigation on the Quality of Adverse Event Monitoring in Medical Instrument Clinical Trials
周珂 1孙海宁 1于秀淳1
作者信息
- 1. 济南军区总医院 骨病科，山东 济南250031
- 折叠
摘要
Abstract
Objective To promote the standardized management of adverse events in medical instrument clinical trial in the hospital. Methods In view of medical device adverse events, a series of special rectification activities were launched in the department. The pre- and post-rectification awareness of adverse events were investigated by using questionnaire survey. In contrast with the cognitive scoring criteria for medical device clinical trial adverse event, the pre- and post-rectification cognitive scores were compared and analyzed. The post-rectification problem in the implementation of adverse event monitoring was also analyzed. Results The post-rectification cognitive level of adverse events was improved (P<0.001). The score rate of the key points of the investigation was significantly improved (P<0.05). However, the post-rectification average cognitive score was less than 70 points, which indicated a big improvement space. The lowest score was in the subject protection factor, which reflected the researchers’ ignorance of the subjects’ rights and interests. In addition, there were still unstandardized phenomena in the prevention and reporting of adverse events, as well as the protection of the subjects. Conclusion Strengthened clinical trial monitoring of adverse events and constantly-improved safety monitoring system were needed to enhance the quality and level of medical instrument clinical trials.关键词
医疗器械/临床试验/不良事件/监控质量Key words
medical instrument/clinical trial/adverse events/monitoring quality分类
医药卫生引用本文复制引用
周珂,孙海宁,于秀淳..医疗器械临床试验不良事件监控质量调查[J].中国医疗设备,2016,31(11):129-132,4.
