Quality control within the Asthma Clinical Research Network

被引:15
作者
Martin, RJ
Kephart, DK
Dyer, AM
Fahy, J
Kraft, M
机构
[1] Natl Jewish Med & Res Ctr, Denver, CO 80206 USA
[2] Penn State Univ, Coll Med, Dept Hlth Evaluat Sci, Hershey, PA USA
[3] Univ Calif San Francisco, San Francisco, CA 94143 USA
来源
CONTROLLED CLINICAL TRIALS | 2001年 / 22卷 / 06期
关键词
clinical center performance; training; certification; site visits; manual of operations;
D O I
10.1016/S0197-2456(01)00164-7
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
Quality control and assurance are very important issues for multicenter clinical investigation. Although such investigation usually states that those factors are part of the investigation, at best this occurs to a minimal extent. Indeed, to ensure the best possible investigatory results with the least amount of variance between centers, the Asthma Clinical Res arch Network (ACRN) instituted strict written criteria that were continually overviewed. This article describes the ACRN's quality control of: clinic procedures and equipment, training and certification of study personnel, site visit evaluations, and the procedures of bronchoscopy and sputum induction. The examples given in this report demonstrate how various aspects of our investigation are performed. (C) Elsevier Science Inc. 2001.
引用
收藏
页码:207S / 221S
页数:15
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