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| 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. |
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