Risk management of medical equipment clinical trial
10.7687/j.issn1003-8868.2018.03.087
- VernacularTitle:医疗器械临床试验风险管理的问题及对策
- Author:
Xiao-Yan ZHANG
1
;
Xue-Jun WANG
;
Dan-Dan ZHU
;
Yue-Fei LI
Author Information
1. 内蒙古自治区人民医院医学工程处
- Keywords:
medical equipment;
clinical trial;
risk management;
risk minimization;
continuous improvement
- From:
Chinese Medical Equipment Journal
2018;39(3):87-89,93
- CountryChina
- Language:Chinese
-
Abstract:
Objective To propose a set of management methods for minimized risk and continuous improvement of medical equipment clinical trial.Methods The problems were summarized on pre-trial preparation,design and signing of informed consent,insurance-related issues,supervision and quality control,perception of adverse events,and then some countermeas-ures were put forward accordingly.Results A risk management system was established for medical equipment clinical trial whole-course management.Conclusion Planning,recognition and evaluation have to be implemented over all the links of medical equipment clinical trial risk management,and corresponding countermeasures should be carried out for minimized risk and continuous improvement.
