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This meeting is scheduled AFTER all the forms, study design and methods have been finalized.  StudyTRAX staff organize the details of the study requirements into a setup plan using a semi-structured, interview-type document called the "Project Setup Document" (see example image below).  Items covered include:

  • 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 Page from 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