Clinical test qualification revelation review the inspection of standardized management agency
10.3760/cma.j.issn.1006-1924.2015.04.022
- VernacularTitle:药物临床试验机构资格认定复核检查工作对机构规范化管理的启示
- Author:
Yan YAN
;
Gang SHI
;
Weiwei GAO
;
Tiannan MEN
- Publication Type:Journal Article
- Keywords:
Drug clinical trial institutions;
Review check;
Standardized management
- From:
Chinese Journal of Medical Science Research Management
2015;28(4):357-360,封4
- CountryChina
- Language:Chinese
-
Abstract:
This article from the clinical trials of the drug inspection agency review practice of view,summarize the key elements of drug clinical trials review examination,the status of agency offices of the daily management and analysis of the problems,the agency's Office to review how the inspection standards as a guide to clinical trial program files,personnel and other standardized management were discussed,with a view of other drugs in clinical trials and routine inspection agency review management to bring new inspiration,clinical trials of drugs for hospitals and fast construction and development agencies to provide a reference.
