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Element NameStudyEndPoint
Parent Element(s)StudyEndPoints
Element XPath(s)/ODM/Study/MetaDataVersion/Protocol/StudyEndPoints/StudyEndPoint
Element Textual ValueNone
Usage
  • Optional
  • Cardinality: 0 or more
AttributesOID, Name,
Child ElementsDescription?
AttributeSchema Datatype
or Enumeration
UsageDefinitionBusiness Rules
OIDoidRequiredUnique identifier for the StudyEndPoint elementThe OID attribute for the  StudyEndPoint must be unique within the Study.
NamenameRequiredHuman readable identifier for the StudyEndPoint  element.The Name must be unique within the set of  StudyEndPoints elements for the Study.
Type(Simple,Humane,Surrogate,Composite)OptionalThe type of end pointSimple: TODO
Humane: the point at which pain and/or distress is terminated, minimized or reduced 
Surrogate: a measure of effect of a specific treatment that may correlate with a real clinical endpoint but doesn't necessarily have a guaranteed relationship, e.g. a biomarker
Combined: end point that is a compbination of several measure. Example: a heart attack study may report the incidence of the combined endpoint of chest pain, myocardial infarction, or death.

A study end point reflects an outcome measure of interest that is statistically analyzed to address a particular research question for the study.
It typically specifies the type of assessments made, the timing of those assessments, the assessment tools used, and possibly other details, as applicable, such as how multiple assessments within an individual are to be combined

End points are typically associated with study objectives.

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