How to conduct supervision and inspection for Investigator-Initiated Trials: Insights from Beijing
10.3760/cma.j.cn113565-20240319-00081
- VernacularTitle:如何开展研究者发起的临床研究监督检查
- Author:
Huijuan LI
1
;
Jie YUAN
;
Yangfeng WU
Author Information
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
- Keywords:
Clinical research;
Supervisory management;
Index system
- From:
Chinese Journal of Medical Science Research Management
2024;37(4):339-343
- CountryChina
- Language:Chinese
-
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 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.Results:This 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.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.
