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Attribute | What’s Needed | Default Used if no information provided |
|---|---|---|
Variable Name | Descriptive Name | |
Unique code (no spaces/special characters [underscore ok]) | ||
Variable Type | Numeric – What is the range (min / max)? Units? | No range, no unit |
Calculation - How calculated? What if missing some values? | All values required for a calculation | |
Text - How many characters needed?
| Unlimited for questions like "Describe", "Comments" | |
Date – What is acceptable range? | Any valid date can be entered | |
Document – How many files and how large? | ||
Picklist (Coded list of value/label pairs, such as 0 = Male, 1 = Female). - What are the values and labels for all options? - do you want values displayed for data entry? - Can more than one option be selected? | 0=No, 1=Yes Other lists would start with 0 and increment by 1 Values are not displayed Only one option can be selected | |
Other | Exportable – Can values be exported in dataset? | Exportable |
Missing Values – Will value/label pairs are defined as “Missing” (e.g., Missing = -9)? | No missing value definition set up if not specified | |
Required - Must a value be entered? | Yes | |
| Skip Patterns - When is the variable/form either shown / hidden? | Always visible | |
| Target User - Will subjects or staff fill out the form? | Staff |
A good data definition provides ALL the characteristics forms (questionnaires, CRFs) and associated variables. What is needed is good old "TLV".
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