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AttributeSchema Datatype
or Enumeration		UsageDefinitionBusiness Rule(s)
OIDoidRequiredUnique identifier for the StudyEndPoint element
  • The 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)Optional

The 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.

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

 [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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