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What is a clinical trial protocol?

Published online by Cambridge University Press:  11 April 2011

Andrea Cipriani and
Corrado Barbui
Andrea Cipriani*
Affiliation:
Department of Medicine and Public Health, Section of Psychiatry and Clinical Psychology, University of Verona (Italy)
Corrado Barbui
Affiliation:
Department of Medicine and Public Health, Section of Psychiatry and Clinical Psychology, University of Verona (Italy)
*
Dr. A. Cipriani, Department of Medicine and Public Health, Section of Psychiatry and Clinical Psychology, University of Verona, Piazzale L.A. Scuro 10, 37134 Verona (Italy). Fax: +39-045-8027498 E-mail: andrea.cipriani@univr.it
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Abstract

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Trial protocols are documents that describe the objectives, design, methodology, statistical considerations and aspects related to the organization of clinical trials. Trial protocols provide the background and rationale for conducting a study, highlighting specific research questions that are addressed, and taking into consideration ethical issues. Trial protocols must meet a standard that adheres to the principles of Good Clinical Practice, and are used to obtain ethics approval by local Ethics Committees or Institutional Review Boards.

Keywords

study protocoloutcomerandomized controlled trialrating scalestatistics

Information

Type
ABC of Methodology
Information
Epidemiology and Psychiatric Sciences , Volume 19 , Issue 2 , June 2010, pp. 116 - 117
Copyright
Copyright © Cambridge University Press 2010

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