Application of ISO9001 Quality Management Standards in the Construction of Clinical Drug Trial Institution
- VernacularTitle:ISO9001质量管理标准在药物临床试验机构建设中的应用
- Author:
Zehong HUANG
;
Shenren CHEN
;
Minghua ZHUANG
;
Ping LIN
- Publication Type:Journal Article
- Keywords:
ISO9001 quality management standards;
Clinical drug trial;
Institution construction
- From:
China Pharmacy
2005;0(14):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To guarantee the quality of the clinical drug trial and to ensure the interests of the subjects.ME- THODS:The basic principles,procedures and methods of ISO9001quality management standards were applied in the whole construction of clinical drug trial institution.RESULTS&CONCLUSION:The construction of clinical drug trial institution based on the ISO9001quality management standards was in conformity with the principle of Good Clinical Practice,which was helpful for the guarantee of the quality of clinical drug trial and the interests the subjects.
