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Common Data Element:  Adverse event attribution indicator

Listed below are the details for the data element.

1.2
Element Type
Common Data Element
Adverse event attribution indicator
AdvrsEvntAttrInd
Short Description
Indicator of whether the adverse event was cause by the treatment in question.
Definition
Indicator of whether the adverse event was cause by the treatment in question.
 

Biomedical Terminologies and Standards

Notes
Based on the sponsor's assessment, is there at least a reasonable possibility that the adverse event was caused by use of the investigational agent or device?
Creation Date
Historical Notes
References
No references available

Data Type
Alphanumeric
Input Restrictions
Single Pre-Defined Value Selected
Pre-Defined Values
External Schema Permissible Value Mapping
Population
Adult and Pediatric
Guidelines/Instructions
No instructions available
Preferred Question Text
Category Groups and Classifications
DiseaseDomainSub-Domain
General (For all diseases) Safety Data Adverse Events
Traumatic Brain Injury Disease/Injury Related Events Classification

Classification

Concussion/Mild TBI :
Supplemental
General (For all diseases) :
Supplemental
Epidemiology :
Supplemental
Acute Hospitalized :
Supplemental
Moderate/Severe TBI: Rehabilitation :
Supplemental
Keywords
AE_Mapped , Adverse_Event
Labels
Effective Date
Until Date
Last Change Date
Wed Apr 24 16:43:18 EDT 2024
See Also
AdverseEvntEndDateTime
Submitting Organization Name
NIH/NINDS
Submitting Contact Name
NINDSCDE
Submitting Contact Information
NINDSCDE@emmes.com
Steward Organization Name
NIH/NINDS
Steward Contact Name
NINDSCDE
Steward Contact Information
NINDSCDE@emmes.com
NINDS ID

Change History