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".
| Stands For.. | Overview | |
|---|---|---|
T | Type of Variable | The most common types are dates, number, coded variables (e.g., 0 = No, 1 = Yes;). |
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) |
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
df
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 | ||
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
*Event created and forms completed as needed