Module 1.8 Developing an Assessment Plan

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Module 1.8 provides a comprehensive overview of developing a REMS Assessment Plan and the role it plays in evaluating the effectiveness of a REMS program over time. The module explains required assessment components, including assessment categories, metric selection, data sources, submission timetables, and methodological rigor, with particular emphasis on evaluating ETASU effectiveness. Learners are introduced to key assessment categories—such as program outreach, implementation, knowledge, safe use behaviors, and health outcomes—and how to select appropriate metrics and data sources to measure both process and outcome indicators. The module also addresses FDA expectations for assessment reporting, corrective action frameworks, and use of real-world data, concluding with a practical example of an assessment plan and references to FDA guidance to support compliant and effective REMS evaluations.