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 postrectification
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.
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.
ZHOU Ke, SUN Hai-ning,
YU Xiu-chun. Investigation on the Quality of Adverse Event Monitoring in Medical Instrument
Clinical Trials. China Medical Devices, 2016, 31(11): 129-132.