D Protocol template

  1. Table of contents
  2. List of abbreviations
  3. Abstract
  4. Amendments and Updates
  5. Milestones
  6. Rationale and Background
  7. Study Objectives
    • Primary Hypotheses
    • Secondary Hypotheses
    • Primary Objectives
    • Secondary Objectives
  8. Research methods
    • Study Design
    • Data Source(s)
    • Study population
    • Exposures
    • Outcomes
    • Covariates
  9. Data Analysis Plan
    • Calculation of time-at risk
    • Model Specification
    • Pooling effect estimates across databases
    • Analyses to perform
    • Output
    • Evidence Evaluation
  10. Study Diagnostics
    • Sample Size and Study Power
    • Cohort Comparability
    • Systematic Error Assessment
  11. Strengths and Limitations of the Research Methods
  12. Protection of Human Subjects
  13. Management and Reporting of Adverse Events and Adverse Reactions
  14. Plans for Disseminating and Communicating Study Results
  15. Appendix: Negative controls
  16. References