Four dimensions of receiving overseas clinical trial data about drug and medical devices / 中国临床药理学与治疗学
Chinese Journal of Clinical Pharmacology and Therapeutics
; (12): 835-840, 2020.
Article
em Zh
| WPRIM
| ID: wpr-855821
Biblioteca responsável:
WPRO
ABSTRACT
China has started to accept the overseas clinical trial data about drug and medical devices, and the data in accordance with the requirements can be used to register in China. To do this work well, we should consider four key dimensions: data acceptance principle, data quality and reliability, data evaluation usability and data international difference. Among them, the authenticity, integrity, accuracy and traceability of data are the main factors to determine the quality reliability of data. Receiving data from overseas clinical trials about drug and medical devices will be conducive to the establishment of international mutual recognition system for clinical trial data, and to enhance the importance of data management in domestic clinical trials, and to promote the formation of quality management system on clinical trial data.
Texto completo:
1
Base de dados:
WPRIM
Idioma:
Zh
Revista:
Chinese Journal of Clinical Pharmacology and Therapeutics
Ano de publicação:
2020
Tipo de documento:
Article