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endpoint-definition-designer

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Designs primary, secondary, and exploratory endpoints for biomedical and clinical research protocols. Always use this skill when a user needs to translate study aims into operational endpoint definitions with event rules, assessment timing, composite logic, interpretability, and protocol-stage auditability. Focus on endpoint precision, feasibility, clinical meaning, ambiguity reduction, and implementation readiness rather than generic study design advice.

When to use

• translating study aims into operational endpoint definitions
• defining primary, secondary, and exploratory endpoints
• specifying event rules and operational triggers
• defining assessment timing and follow-up windows
• defining composite endpoint logic
• pressure-testing primary endpoint choices
• refining draft protocol sections for endpoints
• defining endpoints for biomarker, translational, cohort, or intervention studies

When not to use

• patient-specific clinical outcome prediction
• adjudicating real patient events from live records
• direct treatment recommendations
• non-biomedical endpoint work

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