Our website detected that you are using a browser (Internet Explorer) that we no longer support. Please use the following browsers instead: Chrome, Firefox, Edge, or Safari.

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
Epidemiology
Concussion/Mild TBI
Moderate/Severe TBI: Rehabilitation
Acute Hospitalized
General (For all diseases):
Supplemental
Keywords
Labels