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A good data definition provides a complete description of ALL the characteristics associated with a variable.  We love your variables and what we need to fully appreciate their goodness is good old "TLV" from you.

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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

Tell us about your forms and variables 

Keep It Simple!!

The standard look and feel a is one row per variable layout which is standard practice and always used if possible.

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Mark It UP!!

Give each one of your forms and variables some good-old "TLV" and Mark It Up before sending it to us!

Example Marked Up Form

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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

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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

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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

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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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Does the format / layout matter? (easiest/simplest electronic user-experience)

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Describe any special formatting

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Skip Patterns

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Formatting and Layout

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Will subjects enter the data?  (i.e, need multi-device format)


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

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

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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

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X

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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

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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

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X

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Tuberculosis Test

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X

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Vital Signs

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X

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X

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X

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X

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X

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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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Always visible

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