The table below contains the basic elements of the Studytrax data definition and the defaults used if the Studytrax team assists with setup. Use the data definition spreadsheet (DataDictionaryTemplateBasic.xlsx) to ensure forms/CRFs/Questionnaires are set up correctly. Learn more about how to communicate the data definition here.
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
A form's spatial and visual layout can be it's most important validation (see examples here).
Connect Forms And Variables
The standard loo
Connect Forms and Variables
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Form (CRF/Questionnaire/Measure) Information
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Attribute
...
What’s Needed
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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
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Form
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Skip logic / condition
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Pregnancy Test
...
Hide form for males
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Demographic Data
...
Show text box if ‘other’ is selected for Race
Example: Data Collection Forms Schedule
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Time
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-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
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Windows
...
±10dys
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±1day
...
±2wks
...
±1mth
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N/A
...
N/A
...
Visit
...
Screening
...
Baseline
...
Visit 1
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Visit 2
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Visit 3
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*Protocol Deviation
...
*AE
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Visit Overview
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X
...
X
...
X
...
X
...
X
...
Study Eligibility
...
X
...
Physical Exam
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X
...
X
...
X
...
X
...
X
...
X
...
Demographic Data
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X
...
Complete Blood Count (CBC)
...
X
...
X
...
X
...
X
...
Electrocardiogram (ECG)
...
X
...
X
...
X
...
Pregnancy Test
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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
...
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
...