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

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。

ObjectiveTo 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.MethodsThrough literature analysis combined 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.ResultsThis article detailed the formation and training of supervisory inspectors,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.ConclusionsThis 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.