A good data definition provides a completion description of ALL the characteristics associated with a variable, form, or study event. Below are some guidelines for each.
Variable Information
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.
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? |
...
...
Coded list (e.g., 0 = Male…)
...
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 |
...
Definition
...
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 |
...
Form (CRF/Questionnaire/Measure) Information
...
...
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
| Skip Patterns - When is the variable/form either shown / hidden? |
Example of Skip Pattern logic
Form | Skip logic / condition |
Pregnancy Test | Hide form for males |
Demographic Data | Show text box if ‘other’ is selected for Race |
Data Collection Forms Schedule
Time | -10d | Day 0 | Day 7 | Day 14 | Day 28 | Month 6 | Month 12 |
|---|---|---|---|---|---|---|---|
Windows | ±10d |
| ±1d | ±2d | ±2d | ±14d | ±14d |
Visit | Screening | Base- line | Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 |
Visit Overview | X | X | X | X | X | X | X |
Study Eligibility | X |
|
|
|
|
|
|
Physical Exam | X | X | X | X | X | X | X |
Demographic Data | X |
|
|
|
|
|
|
Complete Blood Count (CBC) | X |
| X | X | X | X | X |
Electrocardiogram (ECG) | X | X |
|
| X |
|
|
Pregnancy Test | X | X |
|
| X | X | X |
Tuberculosis Test | X |
|
|
|
|
|
|
Vital Signs | X | X | X | X | X | X | X |
Adverse Event (AE) | O | O | O | O | O | O | O |
Protocol Deviation | O | O | O | O | O | O | O |
X = forms required to be filled out for visit
...
| Always visible | ||
| Target User - Will subjects or staff fill out the form? | Staff |