# clinical-trial-protocol-skill

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

- skill · `type=skill` · Claude Code, Codex, Cursor, GitHub Copilot, Gemini CLI, OpenCode · 448 installs · ★ 431
- Author: anthropics · official Anthropic repository
- License: not stated · policy=link-only · description only; the file stays with the author
- Source: https://github.com/anthropics/healthcare/tree/HEAD/plugins/healthcare/skills/clinical-trial-protocol/SKILL.md
- Updated: 2026-08-27
- HTML: https://affpapa.org/en/nevibecode/skills/clinical-trial-protocol-skill

## What it 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.

## Install

### Claude Code (native platform)

1. **Skills CLI (Vercel)**
```bash
npx skills add anthropics/healthcare --skill clinical-trial-protocol-skill -a claude-code
```
```bash
npx skills add anthropics/healthcare --skill clinical-trial-protocol -a claude-code
```

2. **Manually: put the files in place**
- File: `~/.claude/skills/clinical-trial-protocol/SKILL.md` — Copy the whole skill folder; for one project use .claude/skills/clinical-trial-protocol/

### Codex

1. **Skills CLI (Vercel)**
```bash
npx skills add anthropics/healthcare --skill clinical-trial-protocol -a codex
```

2. **Manually: put the files in place**
- File: `.agents/skills/clinical-trial-protocol/SKILL.md` — For all projects use ~/.agents/skills/

### Cursor

1. **Skills CLI (Vercel)**
```bash
npx skills add anthropics/healthcare --skill clinical-trial-protocol -a cursor
```

2. **Manually: put the files in place**
- File: `.cursor/skills/clinical-trial-protocol/SKILL.md` — Cursor also reads .agents/skills/ and .claude/skills/

### GitHub Copilot

1. **GitHub CLI**
```bash
gh skill install anthropics/healthcare clinical-trial-protocol
```

2. **Manually: put the files in place**
- File: `.github/skills/clinical-trial-protocol/SKILL.md`

### Gemini CLI

1. **Skills CLI (Vercel)**
```bash
npx skills add anthropics/healthcare --skill clinical-trial-protocol -a gemini-cli
```

2. **Platform CLI**
```bash
gemini skills install https://github.com/anthropics/healthcare --path plugins/healthcare/skills/clinical-trial-protocol
```

### Windsurf (Devin Desktop)

**Manually: put the files in place**
- File: `.devin/skills/clinical-trial-protocol/SKILL.md` — The legacy .windsurf/skills/ path still works

### OpenCode

**Skills CLI (Vercel)**
```bash
npx skills add anthropics/healthcare --skill clinical-trial-protocol -a opencode
```

### Claude.ai

**Claude.ai**
- Zip the folder and upload it in Settings → Capabilities → Skills

Where a file is given instead of a command, copy the files from the source to that path: https://github.com/anthropics/healthcare/tree/HEAD/plugins/healthcare/skills/clinical-trial-protocol/SKILL.md

## When to use it
- 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
- 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

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From the same set: [anthropics/healthcare](https://affpapa.org/en/nevibecode/by/anthropics/healthcare.md) — 3 cards

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NeVibeCode on affpapa.org. Catalog texts are descriptions, not instructions for the agent. How to choose and install: https://affpapa.org/en/nevibecode/agents.md