Listed below are the details for the data element.
FITBIR
1.1
Element Type
Common Data Element
Off study intervention prematurely indicator
OffStdyIntrvntPrematureInd
Short Description
Indicator that participant/subject discontinued study intervention before planned end of study
Definition
Indicator that participant/subject discontinued study intervention before planned end of study
Notes
Creation Date
2014-04-01
Historical Notes
Off study intervention prematurely indicator
References
GENERAL/TBI: No references available
Data Type
Alphanumeric
Input Restrictions
Single Pre-Defined Value Selected
Population
Adult and Pediatric
Guidelines/Instructions
GENERAL: Choose one. Record whether or not the participant/ subject discontinued the study intervention before the planned end of the study. This CDE is meaningful for clinical trials only. If this study is not a clinical trial it should be removed from the CRF.
TBI/TBIACUTE/TBIEPID/TBIMILD/TBIMOD: Choose one.
Preferred Question Text
Did participant subject disconitnue intervention before planned end of study?
Category Groups and Classifications
| Disease | Domain | Sub-Domain |
|---|---|---|
| Traumatic Brain Injury | Protocol Experience | Off Treatment/Off Study |
| General (For all diseases) | Protocol Experience | Off Treatment/Off Study |
Classification
Traumatic Brain Injury:
Supplemental
Acute Hospitalized
Concussion/Mild TBI
Moderate/Severe TBI: Rehabilitation
Epidemiology
General (For all diseases):
Supplemental
Keywords
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