Protocol Submission

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