Glossary Definition

A planned measurement described in the protocol that is used to determine the effect of interventions on participants in a clinical trial. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include Primary Outcome Measure and Secondary Outcome Measure. (See also Primary and Secondary Outcome Measures data element and Outcome Measure basic results data element on