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  • Data collection schedule
  • Forms (a.k.a., CRFs, questionnaires)
  • Data entry
    • Subjects
    • Staff
    • Data import
  • Study design and methods (e.g., randomization)
  • Administrative issues such as:
    • Sites
    • Users  and roles
    • Training materials
  • Reporting
    • Subject-level (here)
    • Dataset-level (here)
  • Datasets and planned analyses (here

 

Example Part of Project Setup Document example