Management practice of Investigator-Initiated Trials in the new period
10.3760/cma.j.cn113565-20230207-00023
- VernacularTitle:新时期研究者发起的临床研究管理实践
- Author:
Qi ZHU
1
;
Mengshi LI
;
Jing JIN
;
Jinyuan GAO
;
Qian XUE
Author Information
1. 海军军医大学第一附属医院 长海医院临床研究中心，上海 200433
- Keywords:
Investigator-Initiated Trial;
Clinical research management system;
Information management;
Whole process management
- From:
Chinese Journal of Medical Science Research Management
2023;36(4):308-311
- CountryChina
- Language:Chinese
-
Abstract:
Objective:In the context of China′s increasing standardized management requirements of clinical research, this article aims to explore the management methods of investigator-initiated trials in the new period, to provide possible reference for other medical institutions dedicated to clinical research.Methods:According to the requirements set forth by the＂Administrative Measures for Investigator-Initiated Trials in Medical and Health Institutions (Trial)", combined with the hospital management practice, experiences regarding the research management system construction and implementation, management system construction and its implementation effects are summarized and analyzed.Results:By exploring and summarizing the connotation of high-quality clinical research under the New Policy, tailored clinical research management system in our hospital was developed and implemented. And the hospital′s clinical research capability and level have been greatly improved, which enhancing the hospital academic influence, as well as its competence for serving the development of national and regional clinical research.Conclusions:Along with the rapid progress of clinical research, hospitals need to assure the compliance of national laws and regulations, and develop appropriate and applicable institutional management measures to empower the conduct of high quality clinical research.
