Clinical Trials: Rethinking How We Ensure Quality

被引：15

作者：

Landray, Martin J. ^{[1
,2
]}

Grandinetti, Cheryl ^{[3
]}

Kramer, Judith M. ^{[4
]}

Morrison, Briggs W. ^{[5
]}

Ball, Leslie ^{[3
]}

Sherman, Rachel E. ^{[3
]}

机构：

[1] Univ Oxford, Clin Trial Serv Unit, Oxford OX3 7LF, England

[2] Univ Oxford, Epidemiol Studies Unit CTSU, Oxford OX3 7LF, England

[3] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[4] Duke Translat Med Inst, Durham, NC USA

[5] AstraZeneca, Wilmington, DE USA

来源：

DRUG INFORMATION JOURNAL | 2012年 / 46卷 / 06期

关键词：

clinical trial; good clinical practice; monitoring; quality assurance;

D O I：

10.1177/0092861512464372

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

[No abstract available]

引用

页码：657 / 660

页数：4

共 5 条

[1] Clinical trials bureaucracy: unintended consequences of well-intentioned policy
Califf, Robert M.
[J]. CLINICAL TRIALS, 2006, 3 (06) : 496 - 502
[2] International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2005, ICH HARM TRIP GUID Q
[3] Morrison B, 2011, RESULTS RECOMMENDATI
[4] U. S. Department of Health and Human Services Food and Drug Administration, 2011, GUID IND OV CLIN INV
[5] US Food and Drug Administration, 2010, PHARM QUAL 21 CENT R