How to Plan and Design a Clinical Research Project

  • A. A. Zin
  • A. Gullo
  • W. A. Zin


Scientific research is in fact the systematic process of collecting and analyzing data in order to increase the available knowledge on a specific field of interest. To start with it is mandatory that a protocol be established and understood by all personnel involved in the research. This protocol must be approved by an Institutional Review Board (IRB) before the research starts off. The research protocol is a formal written document specifying the study design and the manner in which it will be conducted. It is the blueprint of the study and serves as a guideline throughout the implementation and analysis phases. It details procedures to be followed yielding valid results. The research protocol fulfils scientific, ethical, and organizational requirements so that the study may be conducted efficiently and according to the plan, thus standardizing the procedures for research personnel to follow. The purpose of the study and the setting will determine which professionals will be consulted about the development of the research protocol. Subject area experts, epidemiologists, and/or statisticians can be included.


Null Hypothesis Descriptive Study High Tidal Volume Clinical Research Project Nonexposed Group 
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Suggested Reading

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Copyright information

© Springer-Verlag Italia 2009

Authors and Affiliations

  • A. A. Zin
    • 1
  • A. Gullo
    • 2
  • W. A. Zin
    • 3
  1. 1.Fernandes Figueira InstituteOswaldo Cruz FoundationRio de JaneiroBrazil
  2. 2.Department and School of Anesthesia and Intensive CareCatania University-HospitalCataniaItaly
  3. 3.Carlos Chagas Filho Institute of BiophysicsFederal University of Rio de JaneiroRio de JaneiroBrazil

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