Clinical Trial Protocol Skill

Generates clinical trial protocols for medical devices or drugs through a structured five-step workflow that starts with intervention details, researches similar trials and FDA guidance, then builds out protocol sections covering study design, population criteria, intervention specifics, and operational procedures. Built around a waypoint system that saves progress as JSON and markdown files, so you can stop and resume without losing work. Includes a research-only mode if you just need competitive analysis and regulatory pathway intel without the full protocol. Requires the clinical trials MCP server to search ClinicalTrials.gov and pull trial details. The architecture is thoughtfully modular, each step isolated in its own subskill file, and it even includes a Python script for statistical sample size calculations. This is serious regulatory documentation work, not a quick template filler.

Install to Claude Code

npx -y skills add anthropics/healthcare --skill clinical-trial-protocol-skill --agent claude-code