Course Agenda
  • Planning a data collection strategy
  • How to standardize operations and procedures
  • Electronic data capture – Pros & Cons
  • Data management considerations once a study is launched
  • Data management considerations once a study is finished
  • Regulatory compliance around data management
  • Design
          -  Randomization
          -  Blinding
          -  Sample size calculation
  • Analysis
          -  Baseline assessment
          -  Intention-to-treat analysis
          -  Kaplan-Meier estimator and comparison of survival curves
          -  Cox proportional hazards model
  • Reporting