Discussion on the development and standardized management of professional department in drug clinical trial institutions
10.13699/j.cnki.1001-6821.2015.23.027
- VernacularTitle:药物临床试验机构专业科室建设与规范管理的探索
- Author:
Ming-Ying LU
1
;
Tian-Xiang ZHANG
;
Cai-Xia ZHANG
;
Zu-Yi YUAN
Author Information
1. 西安交通大学 第一附属医院 临床药理机构办公室
- Keywords:
drug clinical trial institution;
professional department;
standardized management
- From:
The Chinese Journal of Clinical Pharmacology
2015;(23):2360-2361
- CountryChina
- Language:Chinese
-
Abstract:
The development and standardized management of professional department is the core of the national drug clinical trial institution development and quality control. Combined with the practice and exploration of the development of drug clinical trial institution in large comprehensive hospitals, this paper states main elements and basic ideas of standardized management of professional department in detailed from the following several aspects: the basic hardware, the formation of good clinical practice ( GCP ) team, the system construction of professional department and the training of investigator.
