湖南省药物临床试验机构首次检查回顾分析及工作建议
Retrospective analysis and work suggestions for the first examination of drug clinical trials in Hunan
杨泽华 1李丹 2王弼君 1李璟兮 1管志美1
作者信息
- 1. 湖南省药品审核查验中心,长沙 410000
- 2. 中南大学湘雅医院,长沙 410000
- 折叠
摘要
目的 总结分析药物临床试验机构新备案机构在首次检查中发现的突出问题,探讨新机构监管过程中的关注重点.方法 对 2023 年湖南省内新备案机构的首次监督检查发现的问题作出汇总和分析.结果 机构主体责任意识不强,内部质量控制环节明显薄弱;专业科室质量意识较差,对临床试验质量管理不够重视.结论 检查员应关注首次检查重点,制订针对性检查方案,对检查结果进行打分分级,加强对新机构的监督把关.
Abstract
Objective To summarize the obvious problems in the first inspection of the new filing in the drug clinical trial institutions,and to determine the key points in the supervision of the new institutions.Methods The problems in the first supervision and inspection of the new filing institutions of Hunan in 2023 were summarized.Results The responsibility consciousness of some institutions was poor,with weak internal quality control.The quality awareness of clinical departments need improvement and clinical departments didn't pay enough attention to the quality management of clinical trials.Conclusion Enough attention should be paid to the first inspection,focusing on targeted inspection plans,scores and grades of the inspection results,and strengthening the supervision and control of new institutions.
关键词
药物临床试验机构/首次备案检查/工作建议Key words
drug clinical trial organization/first record inspection/work suggestion引用本文复制引用
出版年
2024
NETL
NSTL
万方数据