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  • Interventional. Studies in human beings in which individuals are assigned by an investigator based on a protocol to receive specific interventions. Subjects may receive diagnostic, therapeutic or other types of interventions. The assignment of the intervention may or may not be random. The individuals are then followed and biomedical and/or health outcomes are assessed.
  • Non-Interventional. Studies in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study.

The non-interventional category includes observational and ancillary/correlative studies:

  • Include Page
    Observational Study Definition - Include v4.4
    Observational Study Definition - Include v4.4
  • Include Page
    Ancillary-Correlative Definition - Include v4.4
    Ancillary-Correlative Definition - Include v4.4