Chapter

The Anatomy of Trials

Curtis L. Meinert

in An Insider’s Guide to Clinical Trials

Published in print May 2011 | ISBN: 9780199742967
Published online September 2011 | e-ISBN: 9780199897278 | DOI: http://dx.doi.org/10.1093/acprof:oso/9780199742967.003.0005
The Anatomy of Trials

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This chapter describes the elements of a clinical trial. These include the required documents (i.e., study protocol, consent forms, institutional review board approvals, investigator's brochure, manual of operations/handbooks, and data forms/case report forms); funding, trial initiation, single- vs. multicenter trials; sponsor-investigator roles; organization/governance; and meetings.

Keywords: clinical trials; documents; funding; sponsors; investigators; governance; meetings

Chapter.  2946 words. 

Subjects: Medical Statistics and Methodology

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