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     Document your data definition using the spreadsheet spreadsheet sent by Studytrax.  Learn how to complete the spreadsheet here. 

Leverage Standards

     Learn About Data Definition Standards (see here) 

Mark It UPDetermine Forms

       When sending us a form, mark it up with the data definitionStandardized 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)
  • 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)
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• 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. 
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  • 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 

Mark It UP

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

      Example Marked Up Form

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     Document which forms are collected with each study event by completing the Data Collection Schedule (see Data Collection Schedule.doctab on the "NewStudyStartup" spreadsheet (provided by Studytrax staff).