Analysis and Discussion of Problems Founded in Quality Control of Medical Device Clinical Trials.
10.3969/j.issn.1671-7104.2022.05.021
- Author:
Yu LIU
1
;
Mingying LU
1
;
Xia LIU
1
;
Caixia ZHANG
1
Author Information
1. Drug Clinical Trial Institution Office, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061.
- Publication Type:Journal Article
- Keywords:
clinical trial;
medical device;
quality control
- MeSH:
Quality Control;
Research Design
- From:
Chinese Journal of Medical Instrumentation
2022;46(5):578-581
- CountryChina
- Language:Chinese
-
Abstract:
The quality control problems of 49 institutional level medical device clinical trials in hospital from 2016 to 2021 were summarized, and the causes of the problems were analyzed from the perspective of all parties involved in the clinical trial. The improvement measures were discussed, which including improving the management system, strengthening the training of researchers and optimizing the selection method, strengthening the responsibility and regulation consciousness of applicants, and formulating the selection basis of applicants and so on. All the above aims to ensure the quality of clinical trials and provide reference for clinical trial managers and implementers.
