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  • Create Eligibility Inclusion and Exclusion Criteria
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Clinical Decision Support

When a clinical trial is designed it is done so with a target population in mind. The desired characteristics of the target population are specified during the study design phase and are referred to as the Eligibility criteria for the trial.

Eligibility criteria for a trial are specified in terms of inclusion and exclusion criteria. If a potential subject meets all of the inclusion criteria and has none of the exclusion criteria then they are an eligible candidate for enrollment.

Examples of inclusion/exclusion criteria used in Eligibility determination follow:

  • Hemoglobin ? 8.5 g/dl
  • ECOG performance status (PS) 0, 1, or 2

Structured Eligibility Criteria: Use Case Decompositions

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