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clinical-study-designer

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Clinical study design skill for medical device trials including IDE studies and post-market studies

library/specializations/domains/science/biomedical-engineering/skills/clinical-study-designer/SKILL.md

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# Clinical Study Designer Skill

## Purpose

The Clinical Study Designer Skill supports design of clinical studies for medical devices, including IDE studies, post-market studies, and registries, ensuring scientific rigor and regulatory acceptance.

## Capabilities

- Study design selection (RCT, single-arm, registry)
- Endpoint definition guidance
- Sample size calculation (superiority, non-inferiority, equivalence)
- Protocol template generation
- Informed consent template generation
- CRF design assistance
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