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.)
npx skills add mohitagw15856/pm-claude-skills --skill clinical-trial-protocol --agent claude-code
Same command for any agent — swap --agent for codex, cursor, copilot.
Weekly change comes from our own snapshots, not the repository page — it measures attention, not adoption.
# 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 Given "a phase II trial of drug X for condition Y", **produce the full synopsis anyway** — infer a defensible design, endpoints, and eligibility appropriate to the phase and condition, and clearly label every inferred choice as a draft assumption for the study team and statistician to confirm. Never fabric
- Working from a brief
- Required Inputs
- Output Format
- Clinical Trial Protocol Synopsis: [title]
- Quality Checks
- Anti-Patterns
- Based On
What does the clinical-trial-protocol skill do?
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.)
How do I install it?
Run `npx skills add mohitagw15856/pm-claude-skills --skill clinical-trial-protocol --agent claude-code` — it drops the skill into your project so the agent can pick it up. Swap the --agent value for codex, cursor or copilot if you use one of those.
Where does this skill come from?
From mohitagw15856/pm-claude-skills, a repository with 1,255 stars. We read it straight from the repository tree rather than a submitted listing, so what you see here is what is actually published.
Is a popular skill a good skill?
Not necessarily. Stars measure attention, not adoption — a repository can trend for a week and be abandoned. That is why we show the weekly change from our own snapshots next to the total, instead of a single flattering number.