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     Learn About Data Definition Standards (see here) 

Determine Forms

    In cases where the forms are NOT predefined Standardized forms (e.g., a standardized depression measure), determine the variables on a form via a combination of Temporal and Conceptual considerations (see example image):

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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?
    The data definition should note the variables that may be exceptions
  • • Note: Forms can be shared across studies (e.g., Demographics, Contact Information)
  • Are all the variables on a forms ALWAYS collected together?  If not, often best to separate time-related groups of variables (e.g.,
  labs values that are rarely ordered)Conceptual
  • rare vs. common lab values)
  • Image Added
• Domain - What variables belong to a given content domain (e.g., surgical vs. imaging variables)?  As a rule of thumb, forms should be broken down no further than about 5 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.
  , separating "Surgical Characteristics" into "Intraoperative" vs. "Perioperative" Characteristics) 

      Determining Forms Example 

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• • • • , SSN, MRN, bogus auto-generated)
    • Project ID
      • Study specific (i.e., screening ID)
    • Randomization ID
    • Name (i.e., First, Last, Middle Initial)
    • Site 

Mark It UP

     The best preparation for completing the data definition spreadsheet is to mark all forms with the data definition characteristics.

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