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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)
- 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)
- What variables are collected together at specific time points?
- 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.
- 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
- Reference ID
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