Checklist of what to include in a protocol

• General information
• Background  information
• Trial objective and purpose
• Trial design
• Selection and withdrawal of subjects
• Treatment of subjects
• Assessment of efficacy
• Assessment of safety
• Statistics
• Direct access to source data/documents
• Quality control and quality assurance
• Ethics
• Data handling and record keeping
• Financial and insurance matters
• Publication policy 
• Supplements.

From the  ICH - Guideline for Good Clinical Practice, 1996.

This page was last updated on September 2008.