Improving the management level of clinical trial based on the establishment of drug clinical trial center pharmacy / 中华医学科研管理杂志
Chinese Journal of Medical Science Research Management
; (4): 479-480,封3-封4, 2018.
Article
em Zh
| WPRIM
| ID: wpr-735088
Biblioteca responsável:
WPRO
ABSTRACT
Objective To discuss our drug clinical trial institution's experience and findings during the process of establishing drug clinical trial central pharmacy.Methods Analyze the previous key issues identified during the drug management under different modes,discuss the necessity and feasibility of establishing drug clinical trial central pharmacy.Meanwhile,discuss the planning and construction of hardware including location site of the central pharmacy,equipment and facilities,staff,as well as software such as electronic management system and standard operation procedures.Results After the adoption of central trial pharmacy,space and energy are saved,manpower and material resources are saved,the quality of clinical trials also improved.Conclusions Standardized and unified management of investigational drugs through establishing drug clinical trial central pharmacy,is the strong guarantee for the drug safety of human subject,as well as the accuracy and scientificity of trial results.
Texto completo:
1
Base de dados:
WPRIM
Tipo de estudo:
Prognostic_studies
Idioma:
Zh
Revista:
Chinese Journal of Medical Science Research Management
Ano de publicação:
2018
Tipo de documento:
Article