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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 point

Simple: measures the change of a single outcome that is meaningful in the context of the disease being studied. ODM-52 - Getting issue details... STATUS
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.

Level(Primary | Secondary | Exploratory)Optional Level for the Study Endpoint

These are defined in concordance with the ICH M11 Clinical electronic Structured Harmonised Protocol Specification

Primary endpoint(s) are typically efficacy measures that address the main research question [1]

Secondary endpoints are generally not sufficient to influence decision-making alone, but may support the claim of efficacy by demonstrating additional effects or by supporting a causal mechanism. [2] 

Exploratory endpoints (where nominated) typically capture outcomes that occur less frequently or which may be useful for exploring novel hypotheses. [1]

 [1] US Department of Health and Human Services F . 2017. Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER): Multiple Endpoints for Clinical Trials: Guidance for Industry. (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/multiple-endpoints-clinical-trials-guidance-industry)

[2] Biomarkers EndpointS and other tools (BEST) http://www.ncbi.nlm.nih.gov/books/NKB338448/

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