如何开展研究者发起的临床研究监督检查——北京经验介绍
How to conduct supervision and inspection for Investigator-Initiated Trials:Insights from Beijing
李会娟 1苑杰 1武阳丰1
作者信息
- 1. 北京大学临床医学高等研究院北京大学临床研究所,北京 100191
- 折叠
摘要
目的 立足我国临床研究高质量发展的需求,构建一套省级研究者发起的临床研究监督检查方案.方法 以国家卫生健康委员会下发的《医疗卫生机构开展研究者发起的临床研究管理办法(试行)》为依据,运用专家经验、文献查阅等方法提出了北京市研究者发起的临床研究监督检查方案.结果 该方案包括监督检查队伍组建与培训、监督检查项目遴选原则和方法、监督检查内容、工作流程、问题发现分类与严重程度判定标准以及对被查项目进行分类处理的规定.结论 该实施方案为保障研究者发起的临床研究高质量实施提供了宝贵经验,但其实施尚处于试点探索阶段,实施效果有待未来实践检验.
Abstract
Objective To establish a provincial-level supervision and inspection protocol for Investigator-Initiated Trials(IIT)based on the need for high-quality development of clinical research in China.Methods Through literature analysis com-bined with personal work experience,this study proposed a system of clinical research supervision and management in Beijing based on the"Administrative Measures for the Conduct of Investigator-Initiated Trials by Health Care and Medical Institutions(Trial)"issued by the National Health Commission.Results This article detailed the formation and training of supervisory in-spectors,the principles and methods for selecting projects for supervisory inspection,the content of supervisory inspection,workflow,the classification and severity assessment of identified issues,as well as guidelines for the classification and handling of inspected projects.Conclusions This protocol provides valuable experience for ensuring the implementation of high-quality IIT,but its implementation is still in the pilot exploration stage,and its impacts will be evaluated in the next implementation practices.
关键词
临床研究/监督管理/指标体系Key words
Clinical research/Supervisory management/Index system引用本文复制引用
基金项目
首都卫生发展科研专项(首发2022-2G-4253)
出版年
2024
NETL
NSTL
万方数据