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Basic structure of a research protocol

 
  1. Version number and date
  2. Title of the study
  3. Sponsor, funder and investigator(s)
  4. Summary
  5. Background review
  6. Study aim, objectives and outcome measures
  7. Methodology
    • Study design
    • Location / setting
    • Inclusion and exclusion criteria
    • Sample size calculation
    • Recruitment methods
    • Details of intervention(s) and/or procedures
    • Data collection methods and timeline
    • Data analysis methods
  8. Scientific limitations of the study
  9. Ethical considerations
    • Risks of the study and measures to minimise them
    • Potential benefits of the study
    • Confidentiality measures
    • Ethics approval
  10. Plan for publication / dissemination of result
  11. References
  12. Appendices