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This meeting is scheduled AFTER all the forms, study design and methods have been finalized.  The implementation meeting involves cover the details of the Project Setup document (see example image below) so as to gather all the study requirements including:

  • 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

Image Removedcovers plans for training, testing, data sets (see here), and reports (see Subject and Workbench reports).


Preparation To-Do's List

  • Review Studytrax features to be covered (see links above)

Agenda

Getting Organized

  • Review questions
  • Finalize testing plan
  • Gather study-related documents, plan training materials
  • Organize reporting related needs
    • Within Subject (here)
    • Across Subjects (here)
  • Determine needed datasets for reporting and analyses (here