Construction and application of clinical trial quality management based on dedicated team and information mode
10.3760/cma.j.cn111325-20241213-01052
- VernacularTitle:基于专职团队及信息化模式的临床试验质量管理实践
- Author:
Dandan YANG
1
;
Rong SHAO
1
;
Yin HU
1
;
Wei ZHANG
1
;
Bo JIANG
1
Author Information
1. 浙江大学医学院附属第二医院临床药理中心，杭州 310009
- Publication Type:Journal Article
- Keywords:
Quality control;
Informatization;
Clinical trial;
Quality management;
Institution of clinical trial
- From:
Chinese Journal of Hospital Administration
2025;41(7):536-540
- CountryChina
- Language:Chinese
-
Abstract:
The quality of clinical trials is critical to ensuring the safety and rights of participants, and ensuring the reliability of trial data. It directly affects the scientific validity of research conclusions and the effectiveness of regulatory decisions. This study aimed to establish an efficient quality management system to enhance the overall quality of clinical trials. Our hospital had established a dedicated quality control team, and developed a quality management module which was integrated to the clinical trial management system. Since February 2021, the hospital had fully digitized the electronic management of quality control processes, and achieved closed-loop management throughout the entire clinical trial by using this system. Key measures of the system included formulating tailored quality control plans, optimizing the design of quality control checklists, and refining quality control feedback mechanisms to improve management efficiency. In 2024, the annual quality control workload had reached 807 activities, with a completion rate of 93% and a timeliness rate of 91%. These outcomes demonstrate that the system could effectively improve the management quality and efficiency of pharmaceutical and medical devices clinical trials. The system could provide insights and practical references for the standardized implementation and quality assurance of clinical trials.
