clinical-study-designer

# 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 - Statistical analysis plan development - Randomization strategy - Blinding methodology - Interim analysis planning - Adaptive design support ## Usage Guidelines ### When to Use - Designing clinical trials - Calculating sample sizes - Developing protocols - Planning statistical analyses ### Prerequisites - Clinical objectives defined - Target population identified - Comparator strategy determined - Regulatory pathway established ### Best Practices - Select design appropriate for objectives - Ensure adequate statistical power - Plan for missing data - Include clinically meaningful endpoints ## Process Integration This skill integrates with the following processes: - Clinical Study Design and Execution - Clinical Evaluation Report Development - AI/ML Medical Device Development - Post-Market Surveillance System Implementation ## Dependencies - PASS software - nQuery - FDA IDE guidance - ISO 14155 standard - Statistical analysis tools ## Configuration ```yaml clini...