Risk based quality management in clinical trials
10.12092/j.issn.1009-2501.2020.10.016
- VernacularTitle: 基于风险的临床试验质量管理
- Author:
Yongfang WANG
1
Author Information
1. Yantai Zhenghai Bio-Tech Co., Ltd.
- Publication Type:Journal Article
- Keywords:
Clinical trial;
Quality management;
Risk
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2020;25(10):1195-1200
- CountryChina
- Language:Chinese
-
Abstract:
Based on the relevant provisions of the Standard for Good Clinical Practice, combining with the published at home and abroad about the quality of the quality risk management, risk-based quality management, risk management, and other related regulations, this paper summarizes the whole process of clinical trial risk-based quality management as well as the relevant regulations and suggestions for each process from the perspective of the sponsor. The aim is to provide theoretical basis for the next step of conducting risk-based quality management.
