# Trial Protocol

> Draft a clinical trial protocol outline with endpoints, arms, and safety guardrails.

- Skill: `tinyhumansai/trial-protocol` (Agent Skill)
- Install (CLI): `npx skillmds@latest add tinyhumansai/trial-protocol`
- Raw SKILL.md: https://api.skillmd.com/api/skills/tinyhumansai/trial-protocol/raw
- Safety review: pending (external: skill-scanner PASS, skillspector PASS)
- Works with: Claude Code, Claude.ai, OpenAI Codex
- Category: Coding & Dev Tools
- Author: tinyhumansai (https://skillmd.com/u/tinyhumansai)
- Updated: 2026-09-22
- Page: https://skillmd.com/skills/tinyhumansai/trial-protocol

---


# Trial Protocol

Turn a lead candidate into a trial design that can actually answer whether it
works and is safe.

## When to use

- A candidate is ready to move toward the clinic.
- A trial design needs a first structured draft to review.

## Steps

1. **State** the primary question the trial must answer.
2. **Define** the population, inclusion, and exclusion criteria.
3. **Design** the arms, dosing, and randomization.
4. **Choose** the primary and secondary endpoints.
5. **Specify** the safety monitoring and stopping rules.

## Output

A protocol outline: question, population, arms, endpoints, and safety rules,
following the [[Research standards]]. A human researcher owns the lab work.