Clinical study designer

Skill a5c-ai/babysitter/library/specializations/domains/science/biomedical-engineering/skills/clinical-study-designer

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npx -y skills add a5c-ai/babysitter --skill clinical-study-designer

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

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
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