Quality management and indicator system for clinical trials of medical devices
10.12092/j.issn.1009-2501.2023.01.007
- Author:
Jiahui DAI
1
;
Sijia SUN
1
;
Xuefeng XIE
1
;
Xuefeng XIE
2
;
Jiahui DAI
3
;
Sijia SUN
3
;
Xuefeng XIE
3
Author Information
1. Pharmacy College of Anhui Medical University
2. Anhui Provincial Drug Regulatory Scientific Research Center
3. lnflammation and lmmune Mediated Diseases Laboratory of Anhui Province
- Publication Type:Journal Article
- Keywords:
clinical trials;
indicator system;
medical devices;
quality management
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2023;28(1):51-58
- CountryChina
- Language:Chinese
-
Abstract:
AIM: Exploring medical device clinical trial quality management indicator system to continuously improve medical device clinical trial quality system construction. METHODS: Through literature research and Delphi method, we summarized the risks of medical device clinical trials in various aspects such as quality management, clinical trial data, and clinical trial research personnel construction, analyzed the risks and proposed a clinical trial quality management index system, as well as corresponding quality improvement measures. RESULTS: To establish an appropriate medical device clinical trial quality evaluation management tool for quality risk monitoring and management, and to support and help the construction of a medical device clinical trial quality management system. CONCLUSION: To identify risks in various aspects of clinical trials and establish a preliminary assessment index system to provide a reference for the evaluation of the effectiveness of clinical trial quality management.
