Chapter

The study plan

Curtis L. Meinert and Susan Tonascia

in Clinical Trials

Published in print September 1986 | ISBN: 9780195035681
Published online September 2009 | e-ISBN: 9780199864478 | DOI: http://dx.doi.org/10.1093/acprof:oso/9780195035681.003.0011

Series: Monographs in Epidemiology and Biostatistics

The study plan

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The basic elements of the plan for any trial is set long before the first patient is enrolled. The nature of the test treatment and outcome measure will be specified in the funding proposal. Specifics relating to the execution of the study plan may not be addressed until the trial has been funded. This chapter details the items that must be addressed in developing a study plan and treatment protocol for the trial.

Keywords: clinical trials; study plan; treatment plan; study population

Chapter.  3715 words. 

Subjects: Public Health and Epidemiology

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