目的   通过分析广州某三甲医院临床试验用药品规范管理体系构建前后试验用药品超温次数及质控发现缺陷项数量变化情况，为药物临床试验规范开展提供参考。方法   结合某医院临床试验用药品管理实践，以试验用药品超温次数、质控发现缺陷项数量占项目比为评价指标，使用卡方检验进行比较。结果   某医院实施临床试验用药品规范管理体系后，发生试验用药品超温次数由实施前的9次下降至3次，呈明显下降趋势，2018—2020年试验用药品管理方面质控发现缺陷项数量占项目比为70.25%，2021—2023年占项目比为18.90%，实施前后组间比较差异有统计学意义（P＜0.001）。结论   构建临床试验用药品规范管理体系，可以减少试验用药品超温次数和试验用药品管理方面质控发现缺陷项数量，从而保证药物临床试验的质量。

       Objective   To analyze the changes in the number of excessive temperature incidents and the proportion of quality control issues in drug management before and after the establishment of construction and practice of standardized management system in a tertiary hospital in Guangzhou，to provide a reference for drug clinical trials standard development．Methods  Based on the management practice of investigational medicinal products from a hospital，the number of excessive temperature incidents and the proportion of quality control issues in drug management were taken as evaluation index and compared using chi-square tests．Results  After implementing the standardized management system for investigational drugs，the number of temperature exceeding incidents decreased from 9 times to 3 times，showing an obvious decreasing trend，and from 2018 to 2020，the  proportion of quality control issues in drug management accounted for 70.25%，while from 2021 to 2023，it accounted for 18.90%．There was a statistically significant difference between the groups before and after the implementation（P＜0.001）．Conclusions  The establishment of  standardized management  system for investigational medicinal  products can  reduce the  number of excessive temperature incidents and the proportion of quality control issues in drug management，and ensure the quality of drug clinical trials．