University of Vermont

University of Vermont Clinical Research Center

Protocol Development

The exact format of the protocol is not specified.  However, it should include the following elements:

  • Abstract
  • Hypotheses
  • Specific aims
  • Background and study rationale
  • Methods section
  • Power/sample size calculations and statistical analysis plan
  • Human Subjects section, including efforts to include minorities, women, and children.  (See IRB Research Manual for complete information.)
  • Data Safety Monitoring Plan

Last modified September 15 2008 10:39 AM

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