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     Learn About Data Definition Standards (see here

Determine Forms

    For non-standardized Standardized forms (e.g., SF-36) have a predefined data definition.  For all other variables, the main factors that determine what variables to put on a form are:

  • Time  - and Collection Methods (see image)
    • What variables are collected together at specific time points?
      • Note: Forms can be shared across studies (e.g., Demographics, Contact Information)
    Collection Methods -
    • Are all the variables on a forms ALWAYS collected together?  If not, often best to separate time-related groups of variables (e.g., rare vs. common lab values)
    • Image Added
  • Domain - What variables belong to a given content domain (e.g., surgical vs. imaging variables)?
  • Practical -
    • Create Once - Forms are created ONCE and then used at one or more study visits. 
    • Image Added
    • Pre-Defined Fields - Exclude any fields that are pre-defined in Studytrax:
      • Reference ID
        • Global ID (e.g., SSN, MRN, bogus auto-generated)
      • Project ID
        • Study specific (i.e., screening ID)
      • Randomization ID
      • Name (i.e., First, Last, Middle Initial)
      • Site 

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