Journal Article

Building Quality in Clinical Trials With Use of a Quality Systems Approach

Cynthia F. Kleppinger and Leslie K. Ball

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 51, issue Supplement_1, pages S111-S116
Published in print August 2010 | ISSN: 1058-4838
Published online August 2010 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/653058
Building Quality in Clinical Trials With Use of a Quality Systems Approach

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There is an increasing focus on having quality systems in place during the planning stages of clinical trials. Such systems require the development and implementation of standards for each step. Although this is not imposing something totally new on clinical research, a systematic approach will produce a more reliable and useful end product—high-quality data obtained without compromising the protection of human subjects' rights and welfare. A suggested quality system with standards for each step is addressed in this article.

Journal Article.  3352 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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