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Common Data Element: Off study intervention prematurely reason

Listed below are the details for the data element.

FITBIR
1.1
Element Type
Common Data Element
Off study intervention prematurely reason
OffStdyIntrvntPrematurRsn
Short Description
Primary reason participant/subject discontinued study intervention before planned end of study
Definition
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
2014-04-01
Historical Notes
Off study intervention prematurely reason
References
GENERAL/TBI: No references available

Data Type
Alphanumeric
Input Restrictions
Single Pre-Defined Value Selected
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
Reason for premature intervention discontinuation
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
Moderate/Severe TBI: Rehabilitation
Epidemiology
Acute Hospitalized
Concussion/Mild TBI
General (For all diseases):
Supplemental
Keywords
Labels