CT
Clinical Trial Protocol
🔵 Stable🕐 updated 2026-06-29
🔷 SkillSpec L3
pm-health
Draft a clinical trial protocol synopsis with the elements regulators and IRBs expect. Use when asked to write a clinical trial protocol, a study protocol synopsis, a trial design, or to structure endpoints/eligibility/statistics for an interventional study. Produces a structured protocol synopsis — objectives, design, population with eligibility, interventions, endpoints, statistics, and safety/ethics — for expert review. (For non-clinical/UX research, use research-protocol.)
What to give it
▸Intervention & condition — what's being studied, in whom, and the phase.
▸Objective / question — the primary question the trial must answer.
▸Comparator — placebo, standard of care, or active control; and blinding.
▸Outcome of interest — how benefit (and harm) will be measured.
▸Constraints — known population, setting, and any regulatory context.
✅ The bar it holds itself to
Every skill in this library self-verifies — these are this skill's own quality checks, straight from its definition.
✓The primary objective, primary endpoint, and primary analysis are aligned and consistent
✓There is exactly one primary endpoint, clearly measurable and time-anchored
✓Inclusion/exclusion criteria are explicit and operationally checkable
✓Sample-size basis is stated with its assumptions flagged for the statistician
✓Safety monitoring, reporting, and stopping rules are present
✓Ethics/consent/IRB and GCP elements are included; no efficacy/safety data is invented
⚠️ What it refuses to do
Do not invent prior efficacy/safety data or effect sizes — mark them as placeholders to be set
Do not list multiple "primary" endpoints — pick one and demote the rest to secondary
Do not let objective, endpoint, and analysis drift apart — they must answer the same question
Do not present this as regulatory/statistical sign-off — it's a draft for expert review
Do not omit safety monitoring and stopping rules — a protocol without them isn't approvable
Install
npx pm-claude-skills add --agent claude # or codex · cursor · gemini · hermes
# or one-line MCP (every skill, any client):
claude mcp add pm-skills -- npx -y pm-claude-skills-mcpRelated skills
🔌 Embed this skill
Drop this on your blog, docs, or site — it renders a "Run this skill" card:
<div data-pm-skill="clinical-trial-protocol"></div>
<script src="https://mohitagw15856.github.io/pm-claude-skills/embed.js" async></script>💬 Discussion
Clinical Trial Protocol is one of 750 open-source professional AI agent skills — all SkillSpec L3.
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