A good The table below contains the basic elements of the Studytrax 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; Tell us if more than one option can be selected).
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L
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V
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T - Type of Variable
Use A Spreadsheet
Document your data definition using the spreadsheet here.
Mark It UP
If sending us forms (CRFs), mark up the form with the data definition.
Example Marked Up Form
L - Layout and Logic
Keep It Simple
The standard layout a is one row per variable layout (see here) which is standard practice and always used if possible.
Connect Forms And Variables
The standard loo
Connect Forms and Variables
df
Form (CRF/Questionnaire/Measure) Information
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Attribute
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What’s Needed
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History
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Is the form (or similar form) in another StudyTRAX project?
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Formatting and Layout
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Will subjects enter the data? (i.e, need multi-device format)
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Does the format / layout matter? (easiest/simplest electronic user-experience)
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Describe any special formatting
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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
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Hide form for males
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Demographic Data
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Show text box if ‘other’ is selected for Race
Variable Standards and Defaults
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Attribute
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What’s Needed
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Our Default
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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.
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 |
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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? |
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- 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 |
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Other |
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Exportable – Can values be exported in dataset? | Exportable |
Missing Values – Will |
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value/label pairs are defined as “Missing” (e.g., Missing = -9)? |
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| No missing value definition set up if not specified |
Required |
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- Must a value be entered? | Yes |
Example: Data Collection Forms Schedule
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Time
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-10d
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Day 0
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Day 7
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Month 3
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Month 6
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Protocol Deviation
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Adverse Event
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Windows
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±10dys
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±1day
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±2wks
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±1mth
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N/A
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N/A
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Visit
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Screening
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Baseline
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Visit 1
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Visit 2
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Visit 3
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*Protocol Deviation
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*AE
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Visit Overview
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X
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X
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X
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X
...
X
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Study Eligibility
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X
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Physical Exam
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X
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X
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X
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X
...
X
...
X
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Demographic Data
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X
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Complete Blood Count (CBC)
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X
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X
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X
...
X
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Electrocardiogram (ECG)
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X
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X
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X
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Pregnancy Test
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X
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X
...
X
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Tuberculosis Test
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X
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Vital Signs
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X
...
X
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X
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X
...
X
...
X
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Adverse Event (AE) form
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X
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Protocol Deviation
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X
X = forms required to be filled out for visit
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| Skip Patterns - When is the variable/form either shown / hidden? | Always visible | |
| Target User - Will subjects or staff fill out the form? | Staff |