Page Comparison

...

     Document your data definition using the spreadsheet here. NOTE: on the image that appears, click the down arrow (upper right) to download the spreadsheetspreadsheet sent by Studytrax.  Learn how to complete the spreadsheet here.

Leverage Standards

     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):

...

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 

...

• • • • , 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

     When sending us a form, 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

...

     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).