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Common Data Element: Off study intervention prematurely other text

Listed below are the details for the data element.

FITBIR
1.1
Element Type
Common Data Element
Off study intervention prematurely other text
OffStdyIntrvntPrematurOTH
Short Description
The free-text field related to 'Off study intervention prematurely reason' specifying other text. Primary reason participant/subject discontinued study intervention before planned end of study
Definition
The free-text field related to 'Off study intervention prematurely reason' specifying other text. Primary reason participant/subject discontinued study intervention before planned end of study
 
Notes
This Common Data Element is meaningful for clinical trials only. If this study is not a clinical trial it should be removed from the CRF.
Creation Date
2014-06-05
Historical Notes
References
GENERAL/TBI: No references available

Data Type
Alphanumeric
Input Restrictions
Free-Form Entry
Maximum Character Quantity
4000
External Schema Permissible Value Mapping
Population
Adult and Pediatric
Guidelines/Instructions
GENERAL: Choose most appropriate answer. Choose one. Specify the participant's/ subject's primary reason for intervention discontinuation. If the primary reason for interventions discontinuation is "Adverse Event" then an Adverse Event CRF must be completed for this participant/subject. 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 all that apply.
Preferred Question Text
Other, specify
Category Groups and Classifications
DiseaseDomainSub-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
Concussion/Mild TBI
Acute Hospitalized
Moderate/Severe TBI: Rehabilitation
Moderate/Severe TBI: Rehabilitation
Epidemiology
Epidemiology
Acute Hospitalized
Concussion/Mild TBI
Concussion/Mild TBI
Epidemiology
Epidemiology
Moderate/Severe TBI: Rehabilitation
Epidemiology
Concussion/Mild TBI
Moderate/Severe TBI: Rehabilitation
Concussion/Mild TBI
Epidemiology
Moderate/Severe TBI: Rehabilitation
Concussion/Mild TBI
Concussion/Mild TBI
Moderate/Severe TBI: Rehabilitation
Acute Hospitalized
Acute Hospitalized
Acute Hospitalized
Epidemiology
Epidemiology
Concussion/Mild TBI
Acute Hospitalized
Acute Hospitalized
Moderate/Severe TBI: Rehabilitation
Acute Hospitalized
Moderate/Severe TBI: Rehabilitation
General (For all diseases):
Supplemental
Keywords
Labels