What is clinical-trial-protocol-skill?

A guided workflow for creating clinical trial protocols for medicines or medical devices. A clinical trial protocol is the document that explains how a medical study will be designed and run.

Use it to research comparable studies, design a clinical study, and prepare protocol or FDA submission material.

It organizes the research and writing needed for study planning or regulatory documents, including finding similar trials and relevant guidance.

clinical-trial-protocol-skill — Skill for Claude Code and Codex by Sho

Install

Getting it into your agent

One page per mod, every tool's command on it. A separate URL per tool would split the same page into five that compete with each other.

Any agent

npx skills add Shoko-official/Claude-Science-System-Prompts --skill clinical-trial-protocol

Clone the repo

git clone --depth 1 https://github.com/Shoko-official/Claude-Science-System-Prompts

Made for: Claude Code, Codex.

Wrote this? Show the measurements

A badge with what this costs and how it scanned, read live from this page, so it follows the numbers instead of freezing them. Markdown for a README, HTML for a documentation site or a project page.

README.md

[![agentmods](https://agentmods.dev/badge/skills/shoko-official/claude-science-system-prompts/clinical-trial-protocol/github.svg)](https://agentmods.dev/skills/shoko-official/claude-science-system-prompts/clinical-trial-protocol)

Your own site

<a href="https://agentmods.dev/skills/shoko-official/claude-science-system-prompts/clinical-trial-protocol"><img src="https://agentmods.dev/badge/skills/shoko-official/claude-science-system-prompts/clinical-trial-protocol/github.svg" alt="Measured on agentmods" height="20"></a>

Or the 80×15 button, for a site that already has a row of RSS and ATOM ones. Only the verdict fits; the numbers stay here.

Your own site · 80×15

<a href="https://agentmods.dev/skills/shoko-official/claude-science-system-prompts/clinical-trial-protocol"><img src="https://agentmods.dev/badge/skills/shoko-official/claude-science-system-prompts/clinical-trial-protocol.svg" alt="Reviewed on agentmods" width="80" height="20"></a>

Per session 70 Skills are progressive disclosure: only the name and description are preloaded; the body loads when the skill is used.

When invoked 4,686 The whole file, excluding the scripts and references it only reads on demand.

Security scan A 0 findings. A grade says what 26 rules found in the file — not that it is safe.

Origin 100% copy Near-identical to another mod in the catalogue.

Token cost

What it costs to keep this loaded

Counted locally with the o200k_base tokenizer, which is exact for GPT models; Claude uses its own tokenizer and its counts differ. Treat this as one consistent yardstick across the catalogue rather than a bill. Prices are per million input tokens.

Model	Per session	Once invoked
Fable 5.1	$0.00070	$0.04686
Opus 5	$0.00035	$0.02343
Sonnet 5	$0.00014	$0.00937
Haiku 4.5	$0.00007	$0.00469

Measured 12d ago against content hash e60ffb7aaebb, method: parsed. Prices are Anthropic first-party input rates as of 2026-09-12, from the pricing page.

Security

Grade A, and why

clinical-trial-protocol-skill scanned grade A with 0 findings against 26 rules in 11 categories — prompt injection, anti-refusal, data exfiltration, privilege escalation, supply chain, agent snooping, system-prompt leakage, SSRF and excessive agency — measured 12d ago.

The scan reads SKILL.md. This mod also ships 1 executable file (scripts/sample_size_calculator.py), listed below but not scanned — reading those needs a real analyzer, not pattern matching.

A static scan of the body, not an audit. Every finding is printed with the line that produced it so you can judge whether it matters here. A mod is markdown that instructs an agent; that is exactly why what it instructs is worth reading.

Nothing flagged

None of the 26 patterns this scan looks for appear in this file: no shell pipes, no recursive deletes, no credential paths, no hidden text, no instruction-override or anti-refusal phrasing, no agent-config snooping. That is not a guarantee, it is the absence of the things that are checkable.

Origin

This is a copy

100% identical to clinical-trial-protocol-skill — 0 lines differ, which has more behind it and is treated as the original. This page carries a canonical link to it rather than competing with it.

skills/clinical-trial-protocol/SKILL.md · 509 lines

How it starts

The opening of the file, as written. The whole thing — 509 lines — stays where its author put it; the contents beside it link to each section on GitHub.

Clinical Trial Protocol Skill

⚠️ EXECUTION CONTROL - READ THIS FIRST

CRITICAL: This orchestrator follows a SIMPLE START approach:

Display the welcome message FIRST (shown in "Startup: Welcome and Confirmation" section below)
Ask user to confirm they're ready to proceed - Wait for confirmation (yes/no)
Jump directly into Full Workflow Logic - Automatically run subskills sequentially
Do NOT pre-read subskill files - Subskills are loaded on-demand only when their step executes

Why this matters:

Pre-reading all subskills wastes context and memory
Subskills should only load when actually needed during execution
Workflow automatically handles resuming from existing waypoints

Overview

This skill generates clinical trial protocols for medical devices or drugs using a modular, waypoint-based architecture

What This Skill Does

Starting with an intervention idea (device or drug), this orchestrated workflow offers two modes:

🔬 Research Only Mode (Steps 0-1): 0. Initialize Intervention - Collect device or drug information

Research Similar Protocols - Find similar trials, FDA guidance, and published protocols
- Deliverable: Comprehensive research summary as formatted .md artifact

📄 Full Protocol Mode (Steps 0-5): 0. Initialize Intervention - Collect device or drug information

Research Similar Protocols - Find similar trials, FDA guidance, and published protocols
Protocol Foundation - Generate protocol sections 1-6 (foundation, design, population)
Protocol Intervention - Generate protocol sections 7-8 (intervention details)
Protocol Operations - Generate protocol sections 9-12 (assessments, statistics, operations)
Generate Protocol - Create professional file ready for stakeholder review

Architecture

Waypoint-Based Design

All analysis data is stored in waypoints/ directory as JSON/markdown files:

waypoints/
├── intervention_metadata.json           # Intervention info, status, initial context
├── 01_clinical_research_summary.json   # Similar trials, FDA guidance, recommendations
├── 02_protocol_foundation.md            # Protocol sections 1-6 (Step 2)
├── 03_protocol_intervention.md          # Protocol sections 7-8 (Step 3)
├── 04_protocol_operations.md            # Protocol sections 9-12 (Step 4)
├── 02_protocol_draft.md                 # Complete protocol (concatenated in Step 4)
├── 02_protocol_metadata.json            # Protocol metadata
└── 02_sample_size_calculation.json      # Statistical sample size calculation

Read the full file on GitHub · 509 lines

Files

What ships with it

9 files beside SKILL.md in the same directory: the scripts, references and assets a skill reads on demand. Not counted in the per-session cost; read them before you install if any of them is executable.

Changes

What this file has done since we first saw it

Hashed on every crawl. A supply-chain change to an agent config is a question of when, not whether, so the history is kept rather than the latest state alone.

12d ago First seen · 509 lines · 70 tokens per session scan A e60ffb7aaebb

Subscribe to this mod's changes

clinical-trial-protocol-skill is a skill published in the GitHub repository Shoko-official/Claude-Science-System-Prompts (10 stars, last pushed 1mo ago), licensed Apache-2.0. It adds 70 tokens to every session and 4,686 once invoked, about $0.0003 per session on Opus 5. A static security scan graded it A with 0 findings. It is 100% identical to clinical-trial-protocol-skill, differing in 0 lines, and is treated as a copy.

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