Discussions on risk-based quality management of investigator initiated trials
10.3760/cma.j.cn111325-20220225-00158
- VernacularTitle:基于风险的研究者发起的临床研究过程质量管理探讨
- Author:
Wenwen LYU
1
;
Tingting HU
;
Jiayuan JIANG
;
Weituo ZHANG
;
Tiantian QU
;
Enlu SHEN
;
Jiacheng DUAN
;
Tienan FENG
;
Biyun QIAN
Author Information
1. 上海交通大学医学院临床研究中心，上海 200025
- Keywords:
Total quality management;
Scientific research management;
Investigator initiated trials;
Risk-based quality management;
Process management
- From:
Chinese Journal of Hospital Administration
2022;38(7):525-529
- CountryChina
- Language:Chinese
-
Abstract:
Effective supervision of the clinical research management department can guarantee and improve the quality of the investigator initiated trials(IIT). The authors analyzed relevant clinical research regulations and literature and summarized the current situation of risk-based IIT project process quality management. On such basis, they determined the risk-based IIT project process quality management method in combination with the previous research of the research group.From 2021 to 2022, this method was used to implement process quality management for 353 IIT projects in Shanghai′s tertiary hospitals. More than 3 000 risk points were identified through centralized supervision, and then on-site supervision was carried out to correct the problems found. As proven by the results, the method could find existing problems in time and define the risk level of the project, and also formulate an individualized risk supervision plan accordingly, so as to effectively ensure the data reliability and scientific results. It is suggested that the clinical research management department implement risk based management for the whole process of IIT projects, increase funding and staffing, and implement hierarchical management for the projects by research types, so as to promote the sustainable development of IITs.
