A good data definition provides a complete description of ALL the characteristics associated with a variable, form, or study event. 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!!
You love your variables as much as we do, so give each variable some good old TLV and Mark It Up before sending 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