clinical-trial-protocol-skill

clinical-trial-protocol-skill is a skill for Claude Code, Codex from Agent-Threat-Rule/agent-threat-rules. It costs 70 tokens per session (4,686 once invoked), scanned A, original, MIT.

A guided workflow for creating clinical trial protocols for medical devices or drugs. A clinical trial protocol is the plan that explains how a medical study will be run, and the workflow can also research similar trials and regulatory guidance.

In plain words
What is it for?
Use it to develop a study plan, research comparable trials, and prepare documentation for a possible FDA submission.
Why use it?
Designing a medical study requires structured plans and supporting evidence. This workflow helps gather that material before producing protocol or regulatory documentation.

Skill for Claude CodeCodex

Written for no agent in particular: nothing here depends on one.

Good fit Use it to develop a study plan, research comparable trials, and prepare documentation for a possible FDA submission.

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Install with agentmods
npx agentmods add skills/agent-threat-rule/agent-threat-rules/clinical-trial-protocol
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 Agent-Threat-Rule/agent-threat-rules --skill clinical-trial-protocol
Clone the repo
git clone --depth 1 https://github.com/Agent-Threat-Rule/agent-threat-rules

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.

agentmods badge for clinical-trial-protocol-skill

README.md
[![agentmods](https://agentmods.dev/badge/skills/agent-threat-rule/agent-threat-rules/clinical-trial-protocol/github.svg)](https://agentmods.dev/skills/agent-threat-rule/agent-threat-rules/clinical-trial-protocol)
Your own site
<a href="https://agentmods.dev/skills/agent-threat-rule/agent-threat-rules/clinical-trial-protocol"><img src="https://agentmods.dev/badge/skills/agent-threat-rule/agent-threat-rules/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.

agentmods 80×15 button for clinical-trial-protocol-skill

Your own site · 80×15
<a href="https://agentmods.dev/skills/agent-threat-rule/agent-threat-rules/clinical-trial-protocol"><img src="https://agentmods.dev/badge/skills/agent-threat-rule/agent-threat-rules/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 original No closer match found 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.

ModelPer sessionOnce 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 7d 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 7d ago.

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

Copies of this mod

3 near-identical copies found in the catalogue:

data/skills-sh/skills/anthropics/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:

  1. Display the welcome message FIRST (shown in "Startup: Welcome and Confirmation" section below)
  2. Ask user to confirm they're ready to proceed - Wait for confirmation (yes/no)
  3. Jump directly into Full Workflow Logic - Automatically run subskills sequentially
  4. 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

  1. 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

  1. Research Similar Protocols - Find similar trials, FDA guidance, and published protocols
  2. Protocol Foundation - Generate protocol sections 1-6 (foundation, design, population)
  3. Protocol Intervention - Generate protocol sections 7-8 (intervention details)
  4. Protocol Operations - Generate protocol sections 9-12 (assessments, statistics, operations)
  5. 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

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.

  1. 7d 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 Agent-Threat-Rule/agent-threat-rules (389 stars, last pushed yesterday), licensed MIT. 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. No closer match exists in the catalogue, so it is treated as the original; first seen 2026-09-05.

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