Exploration and practice on construction of clinical research integrated management system of a pediatric hospital in Beijing
10.3760/cma.j.cn113565-20240601-00132
- VernacularTitle:北京某儿科医院临床研究一体化管理体系建设探索与实践
- Author:
Yuguang LIANG
1
;
Qian WANG
1
;
Qian DING
1
;
Chunyan GUO
1
;
Meng ZHANG
1
;
Yi ZHANG
1
;
Xiaoling WANG
1
;
Peng GUO
1
Author Information
1. 国家儿童医学中心 首都医科大学附属北京儿童医院临床研究中心，北京 100045
- Publication Type:Journal Article
- Keywords:
Clinical research;
Integrated management;
Improving quality and efficiency
- From:
Chinese Journal of Medical Science Research Management
2025;38(1):69-74
- CountryChina
- Language:Chinese
-
Abstract:
Objective:This study starts from the main problems existing in the current stage of the development of pediatric clinical research in China and focuses on the construction of a clinical research management system. By innovating the platform management model and enhancing personnel skills, we can provide support and assurance for improving the clinical research platform and its sustainable development in the future.Methods:This study established an integrated management platform for Industry-Sponsored Initiated Clinical Research Trial (IST) and Investigator Initiated Clinical Research (IIT) and implement integrated management of IST and IIT projects. At the same time, in response to the weak links in quality management, synchronous training of management and research talents should be implemented to achieve dual improvement in project management quality and platform service efficiency throughout the process.Results:We had optimized the clinical research organization structure, improved the management system, and strengthened the quality supervision of IIT projects by establishing rules and systems to improve the quality and efficiency of project management.Conclusions:Based on analyzing the current situation in China and referring to international experience, we have built a clinical research management platform in line with the development of the hospital, and implemented centralized management of the entire process of IST and IIT projects, strengthened project process quality control, which is expected to provide a reference for peers.
