Investigator-Initiated Trials management measures to study the implementation of the whole process management of new requirements and implementation suggestions
10.3760/cma.j.cn113565-20241024-00279
- VernacularTitle:IIT管理办法对研究实施全流程管理的新要求及实施建议
- Author:
Honglei NIAN
1
;
Jihong LI
;
Jiyin ZHOU
Author Information
1. 首都医科大学附属北京世纪坛医院伦理委员会办公室，北京 100038
- Publication Type:Journal Article
- Keywords:
Investigator-Initiated Trials;
Scientific review;
Scientific research management
- From:
Chinese Journal of Medical Science Research Management
2025;38(2):114-119
- CountryChina
- Language:Chinese
-
Abstract:
Objective:As the " Administrative Measures for Conducting investigator-initiated Clinical Research in Medical and Health Institutions" promulgated, to explore the key points and difficulties in the management of Investigator-Initiated Trials(IIT) in healthcare institutions, and provide basis for promoting the standardization and high-quality management of IIT.Methods:On the basis of policy text research , through literature investigation and working practice, this paper analyzes new requirements of the Management Measures for clinical trials management and puts forward implementation suggestions.Results:The Administrative Measures put forward new requirements for the implementation and management of clinical trials from the aspects of scientific review and ethical review, and carried out intervention research beyond the scope, clinical research management committee responsibilities. Medical and carried institutions need to strengthen the management of the whole process of clinical trials implementation.Conclusions:Medical and health institutions can strengthen clinical trials management by building the organizational structure of clinical trials whole-process management, hierarchical risk management, taking scientific review as the starting point, opening up all aspects of project management, focusing on process management, and strengthening quality control and quality assurance.
