关键词: 医疗失效模式与效应分析, I期临床试验, 血液样本, 质量管理, 研究者

Abstract: AIM: To explore the application effect of medical failure mode and effect analysis in the blood sample management of phase I clinical trials, and to provide a basis for improving the quality of blood sample management.  METHODS: Convenient sampling was used to draw blood samples from healthy subjects in phase I clinical trials as the research objects. According to whether the medical failure mode and effect analysis method was implemented, they were divided into 3 080 control groups and 3 064 observation groups. The unqualified rate of blood samples, the number of unqualified items, the satisfaction of subjects and the passing rate of the researcher's examination between the two groups were compared. RESULTS: The unqualified rate of blood samples in the control group was 1.95%, and the unqualified rate of blood samples in the observation group was 0.59%. The difference between the two groups was statistically significant (P<0.05).  The number of unqualified items in the blood samples of the observation group was lower than that of the control group, and the difference between the two groups was statistically significant (P<0.05). The satisfaction of subjects in the observation group and the passing rate of the investigator were higher than those in the control group, and the difference between the two groups was statistically significant (P<0.05). CONCLUSION: The implementation of medical failure mode and effect analysis not only provides qualified biological samples for the detection and analysis of drug concentration in clinical trials, but also enhances the standardization and specialization of researchers, and contributes to the improvement of the overall quality of clinical trials.

Key words: analysis of medical failure modes and effects, phase I clinical trial, blood samples, quality management, researcher