| Element Name | StudyEndPoint |
|---|---|
| Parent Element(s) | StudyEndPoints |
| Element XPath(s) | /ODM/Study/MetaDataVersion/Protocol/StudyEndPoints/StudyEndPoint |
| Element Textual Value | None |
| Usage |
|
| Attributes | OID, Name, Type |
| Child Elements | Description? FormalExpression* |
| Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rules |
|---|---|---|---|---|
| OID | oid | Required | Unique identifier for the StudyEndPoint element | The OID attribute for the StudyEndPoint must be unique within the Study. |
| Name | name | Required | Human 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) | Optional | The type of end point | Simple: 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.
Example
StudyEndPoint
<StudyEndPoint OID="SEP.WEIGHT_LOSS" Name="Weight loss end point">
<Description>
<TranslatedText xml:lang="en" Type="text/plain">Absolute change from baseline weight at 1 year</TranslatedText>
<FormalExpression Context="ODMPath">
StudyEventData.where(StudyEventOID='SE.VISIT1').ItemGroupData.where(ItemGroupOID='IG.VITALS').ItemData.where(ItemOID='IT.WEIGHT).Value
- StudyEventData.where(StudyEventOID='SE.VISIT_1_YEAR').ItemGroupData.where(ItemGroupOID='IG.VITALS').ItemData.where(ItemOID='IT.WEIGHT).Value</FormalExpression>
</Description>
</StudyEndPoint>