中国医学装备2016，Vol.13Issue(3)：115-116,117,3.DOI:10.3969/J.ISSN.1672-8270.2016.03.033
临床试验机构办公室对医疗器械临床试验的质量控制
The quality control of medical devices clinical trials finished by drug clinical research institute office
杨春梅 1袁丹江1
作者信息
- 1. 华中科技大学同济医学院附属荆州医院药物临床试验机构 湖北 荆州 434020
- 折叠
摘要
Abstract
Objective:To ensure the authenticity, scientific and reliability of medical devices clinical trials results.Methods: The drug clinical research institute office set up full-time secondary quality control team, clarified the responsibility, made application form, problem check and track list, subjects’ identity registration form. Using computer network to make 19 medical equipment quality control of clinical trials.Results: Assure the rights and safety of subjects, the validity, accuracy and completeness of clinical trial data and clinical trial results.Conclusion: The drug clinical research institute office, full-time secondary quality control team made strict clinical trial project for the whole process of quality control and ensure the true, scientific and reliable results.关键词
医疗器械临床试验/机构办公室/质量控制Key words
Medical devices clinical trials/Drug clinical research institute office/Quality control分类
医药卫生引用本文复制引用
杨春梅,袁丹江..临床试验机构办公室对医疗器械临床试验的质量控制[J].中国医学装备,2016,13(3):115-116,117,3.
