Risk based quality management in clinical trials / 中国临床药理学与治疗学
Chinese Journal of Clinical Pharmacology and Therapeutics
;
(12): 1195-1200, 2020.
Article
in Chinese
| WPRIM
| ID: wpr-855771
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Type of study:
Etiology study
Language:
Chinese
Journal:
Chinese Journal of Clinical Pharmacology and Therapeutics
Year:
2020
Type:
Article
Similar
MEDLINE
...
LILACS
LIS