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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.
  • 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.
    Jira
    serverIssue Tracker (JIRA)
    serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
    keyODM-52


    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

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