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

clinical-study-designer:
  study-designs:
    - randomized-controlled
    - single-arm
    - crossover
    - registry
    - real-world-evidence
  hypothesis-types:
    - superiority
    - non-inferiority
    - equivalence
  endpoint-types:
    - primary
    - secondary
    - exploratory

Output Artifacts

• Protocol documents
• Statistical analysis plans
• Sample size calculations
• Informed consent templates
• CRF designs
• Randomization schemes
• Study synopses
• IDE submission components

Quality Criteria

• Design appropriate for clinical question
• Sample size adequately powered
• Endpoints clinically meaningful
• Protocol comprehensive
• SAP statistically rigorous
• Documentation supports regulatory acceptance