Data Definition Standards

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 things 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…)

· 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

Definition

Export – Can values be exported in dataset?

Exportable

Missing Values – Will values be assigned as “Missing” (e.g., Missing = -9)?

No missing value definition set up if not specified

Required

Must a value be entered?

Yes

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?

Form

Skip logic / condition

Pregnancy Test

Hide form for males

Demographic Data

Show text box if ‘other’ is selected for Race

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