Individual skill

clinical-trial-protocol

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.)

plugins/pm-health/skills/clinical-trial-protocol/SKILL.md

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# Clinical Trial Protocol Skill

A clinical trial protocol stands or falls on a few linked decisions: a clear objective, a design that can answer
it, endpoints that measure it, eligibility that defines who's studied, and a statistical plan that can detect the
effect. This skill drafts a protocol synopsis that makes those decisions explicit and internally consistent, in
the structure IRBs/ethics committees and regulators expect. (For a general academic or UX study, use
[`research-protocol`](../research-protocol/SKILL.md).)

> **Safety & compliance note:** this is a drafting aid for **expert review**, not regulatory, medical, or
> statistical sign-off. Real trials require qualified investigators, a statistician, and IRB/ethics and
> regulatory approval (e.g. GCP, ICH, local law). Do not invent efficacy/safety data; mark assumptions for the
> study team to set.

## Working from a brief