Discussion on Management Model of Medical Devices for Clinical Trials.
10.3969/j.issn.1671-7104.2020.01.020
- Author:
Bo CHEN
1
;
Jianyuan WU
1
;
Hanning HU
1
;
Xiaoqiu YANG
2
;
Jianying HUANG
1
Author Information
1. Clinical Trial Center, Zhongnan Hospital of Wuhan University, Wuhan, 430071. ##Email#.
2. Scientific Department, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200127. ##Email#.
- Publication Type:Journal Article
- Keywords:
centralization;
management model;
medical devices clinical trials;
medical devices used for clinical trials
- MeSH:
Clinical Trials as Topic;
Equipment and Supplies/standards*;
Indicators and Reagents/standards*;
Reproducibility of Results;
Research Design/standards*
- From:
Chinese Journal of Medical Instrumentation
2020;44(1):88-91
- CountryChina
- Language:Chinese
-
Abstract:
By analyzing the main problems existing in the current management of medical devices for clinical trials, this study proposes a feasible management model and specific requirements for acceptance, distribution, storage and recovery combining with the characteristics of medical consumable equipment and diagnostic reagent, which provides a favorable guarantee for the authenticity and reliability of clinical trials.
