| 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 measures the change of a single outcome that is meaningful in the context of the disease being studied.
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 does not necessarily have a guaranteed relationship (e.g., a biomarker) Combined: end point that is a combination of several measures. Example: A heart attack study may report the incidence of the combined endpoint of chest pain, myocardial infarction, or death. |
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