The table below contains the basic elements of the Studytrax data definition and the defaults used if the Studytrax team assists with setup.
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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T
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The most common types are dates, number, coded variables (e.g., 0 = No, 1 = Yes;).
...
L
...
V
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Communicating
Use A Spreadsheet
Document your data definition using the spreadsheet here.
Mark It UP
When sending us a form, mark it up with the data definition.
Example Marked Up Form
L - Layout and Logic
Keep It Simple
Forms should use the cleanest, simplest layout possible. Standard practice is to use one-row-per-variable (examples here).
Leverage Visual Validation
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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
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Time
...
-10d
...
Day 0
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Day 7
...
Month 3
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Month 6
...
Protocol Deviation
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Adverse Event
...
Windows
...
±10dys
...
±1day
...
±2wks
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±1mth
...
N/A
...
N/A
...
Visit
...
Screening
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Baseline
...
Visit 1
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Visit 2
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Visit 3
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*Protocol Deviation
...
*AE
...
Visit Overview
...
X
...
X
...
X
...
X
...
X
...
Study Eligibility
...
X
...
Physical Exam
...
X
...
X
...
X
...
X
...
X
...
X
...
Demographic Data
...
X
...
Complete Blood Count (CBC)
...
X
...
X
...
X
...
X
...
Electrocardiogram (ECG)
...
X
...
X
...
X
...
Pregnancy Test
...
X
...
X
...
X
...
Tuberculosis Test
...
X
...
Vital Signs
...
X
...
X
...
X
...
X
...
X
...
X
...
Adverse Event (AE) form
...
X
...
Protocol Deviation
...
X
X = forms required to be filled out for visit
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