Construction of Management Model of Clinical Trial Drugs in Our Hospital
10.6039/j.issn.1001-0408.2015.34.05
- VernacularTitle:我院临床试验用药品管理模式的构建
- Author:
Tao LIU
;
Yi WANG
;
Liting DENG
;
Juanping YE
;
Fangyu ZHANG
;
Hongbing HUANG
- Publication Type:Journal Article
- Keywords:
Clinical trial drugs;
Management model;
Clinical trial pharmacy;
Anti-tumor drugs
- From:
China Pharmacy
2015;(34):4766-4769
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To explore the method for the scientific and standard management of clinical trial drugs. METHODS:By theory analysis and empirical analysis,the management model of clinical trial drugs in our hospital was introduced in terms of software and hardware construction of clinical trial pharmacy,the formulation of drug management system and standard operation procedure,regular quality control and drug information management platform construction,etc. RESULTS:In the experience of our hospital,it could safeguard the safety of drug use in subjects and scientificity and preciseness of drug clinical trial results through the concentrated administration trial drugs by full-time pharmacists according to national laws and regulations,management system and standard operation procedure,and regular quality control inspection by quality control group. CONCLUSIONS:Drug clinical trial institute strictly abide the requirements of Good Clinical Practice,strengthen the management of trial drugs and im-prove information management continuously,which is of important significance to construct standardized,detailed and high-effi-ciency centralized management system of clinical trial drugs.
