Protocol Requirements

The research question and methodology must be presented in sufficient detail to permit evaluation of the scientific merit of the project. The protocol should include:

  • Study purpose and rationale
  • Description of the population to be studied, inclusion and exclusion criteria
  • Sample size (and how sample size was determined)
  • Design and detailed description of methodology
  • Definition of end-point(s)
  • Measurements and measurement instruments
  • Data analysis plan
  • How subjects will be recruited, including advertisements/publicity
  • References