A good data definition provides a complete description of ALL the characteristics associated with a variable. We love your variables and what we need to fully appreciate their goodness is good old "TLV" from you.
| Stands For.. | More... | |
|---|---|---|
T | Type of Variable | The most common types are dates, number, coded variables (e.g., 0 = No, 1 = Yes; Tell us if more than one option can be selected). |
L | Layout and Logic | Indicate the look and feel of the variable, and when it should be displayed (e.g., only show if subject is a male). |
V | Validation | Indicate the rules that govern the acceptable variable values (acceptable range, units) |
Keep It Simple!!
The standard look and feel a is one row per variable layout which is standard practice and always used if possible (more examples).
Mark It UP!!
Give each one of your forms and variables some good-old "TLV" and Mark It Up before sending it to us!
Example Marked Up Form
Variable Standards and Defaults
Attribute | What’s Needed | Our Default |
|---|---|---|
Variable Name | Descriptive Name |
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| Unique code (no spaces/special characters [underscore ok]) |
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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 things questions like Describe, Comments
|
| Date – What is acceptable range? | Any valid date can be entered |
| Document – How many files and how large? |
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| Coded list (e.g., 0 = Male…) · 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 |
Definition | Export – Can values be exported in dataset? | Exportable |
| Missing Values – Will values be assigned as “Missing” (e.g., Missing = -9)?
| No missing value definition set up if not specified |
Required | Must a value be entered? | Yes |
Form (CRF/Questionnaire/Measure) Information
Attribute | What’s Needed |
|---|---|
History | Is the form (or similar form) in another StudyTRAX project? |
Formatting and Layout | Will subjects enter the data? (i.e, need multi-device format) |
| Does the format / layout matter? (easiest/simplest electronic user-experience) |
| Describe any special formatting |
Skip Patterns | When is the variable/form either shown / hidden?
|
Example: Skip Pattern logic
Form | Skip logic / condition |
Pregnancy Test | Hide form for males |
Demographic Data | Show text box if ‘other’ is selected for Race |
Example: Data Collection Forms Schedule
Time | -10d | Day 0 | Day 7 | Month 3 | Month 6 | Protocol Deviation | Adverse Event |
|---|---|---|---|---|---|---|---|
Windows | ±10dys |
| ±1day | ±2wks | ±1mth | N/A | N/A |
Visit | Screening | Baseline | Visit 1 | Visit 2 | Visit 3 | *Protocol Deviation | *AE |
Visit Overview | X | X | X | X | X |
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Study Eligibility | X |
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Physical Exam | X | X | X | X | X |
| X |
Demographic Data | X |
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Complete Blood Count (CBC) | X |
| X | X | X |
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Electrocardiogram (ECG) | X | X |
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| X |
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Pregnancy Test | X | X |
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| X |
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Tuberculosis Test | X |
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Vital Signs | X | X | X | X | X |
| X |
Adverse Event (AE) form |
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| X |
Protocol Deviation |
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| X |
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X = forms required to be filled out for visit
*Event created and forms completed as needed