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