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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?

  • Text variables require a limit (can range from 1 to 255 characters)
  • Memo variables do not have a limit

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

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 LogicIndicate the look and feel of the variable, and when it should be displayed (e.g., only show if subject is a male).

V

ValidationIndicate 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

Image Removed

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).

 Image Removed

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


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

...

Always visible

Target User - Will subjects or staff fill out the form?Staff