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clinical-trial-protocol-skill — Claude Code skill: how to install

Builds clinical trial protocols for medical devices and drugs. It helps research prior studies and draft study sections for FDA submissions.

Install into Claude Code · Skills CLI (Vercel) All methods and platforms ↓
npx skills add anthropics/healthcare --skill clinical-trial-protocol-skill -a claude-code
npx skills add anthropics/healthcare --skill clinical-trial-protocol -a claude-code
Open on GitHub

What clinical-trial-protocol-skill does

The skill uses a waypoint-driven workflow that writes intermediate files into waypoints/ as JSON and Markdown. Because progress is cached on disk, you can stop and resume generation at any time. It supports two execution paths: a research-only search through FDA records and similar studies, or an end-to-end authoring flow covering study design and operations.

Individual subskills from references/ load on demand. This keeps context usage low during long runs. For statistical power and group size estimation, the skill calls scripts/sample_size_calculator.py.

Execution relies on an external clinical trials MCP server alongside Python packages scipy >= 1.11.0 and numpy >= 1.24.0. Without the MCP server and these packages, study queries and power calculations fail.

What it helps with

  • extract relevant clinical trials and FDA database precedents
  • calculate statistical sample sizes for study groups
  • draft structured trial protocol sections for an investigational device
  • document operational schedules and participant eligibility rules

Example prompts for the agent

  • Help me design a clinical study for a novel drug candidate
  • Research similar trials and FDA guidance for pembrolizumab
  • Create a clinical trial protocol draft for an investigational medical device

How to install clinical-trial-protocol-skill

1Skills CLI (Vercel)

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

2Manually: put the files in place

~/.claude/skills/clinical-trial-protocol/SKILL.md

Copy the whole skill folder; for one project use .claude/skills/clinical-trial-protocol/

Step by step, with commands for each platform: How to install skills in Claude Code: five ways

Questions about clinical-trial-protocol-skill

How to install clinical-trial-protocol-skill in Claude Code?

Run npx skills add anthropics/healthcare --skill clinical-trial-protocol-skill -a claude-code in your terminal.

What does clinical-trial-protocol-skill do?

It guides trial design through step-by-step waypoints, querying clinical databases and compiling sections for medical device or drug study protocols.

What prerequisites does this skill require?

It requires a functioning clinical trials MCP server for study lookups, plus Python with scipy >= 1.11.0 and numpy >= 1.24.0 for sample size scripts.

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