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Learn About Data Definition Standards (see here)
Determine Forms
In cases where the forms are NOT predefined For non-standardized forms (e.g., a standardized depression measureSF-36), the main factors that determine the what variables to put on a form via a combination of Temporal and Conceptual considerations (see example image)are:
- Temporal Time - 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)
- 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., labs values that are rarely orderedrare vs. common lab values)
- Conceptual 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.
- Pre-Defined Fields - Exclude any fields that are pre-defined in Studytrax:
- Reference ID
- Global ID (e.g.
- Reference ID
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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