Preparatory steps in executing 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:

Series: Monographs in Epidemiology and Biostatistics

Preparatory steps in executing the study plan

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This chapter outlines the steps required in executing the trial, with emphasis on the steps to be carried out in getting started. Topics discussed include essential approvals and clearances, approval maintenance, developing study handbooks and manuals of operations, testing data collection procedures, developing and testing the data management system, training and certification, and phased approach to data collection.

Keywords: clinical trials; approvals; clearance; data collection; study handbooks

Chapter.  5526 words. 

Subjects: Public Health and Epidemiology

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