Individual skill
tooluniverse-clinical-trial-protocol
Generate a full clinical trial protocol document (ICH E6(R2)/FDA-style) for a drug or medical device, including background, objectives/endpoints, study design, population/eligibility, intervention details, assessment schedule, statistical analysis plan with sample-size justification, safety monitoring, and regulatory/ethical sections. Use when users say "generate a clinical trial protocol", "draft a protocol for [drug/device]", "write up the study design as a protocol document", "create an FDA submission protocol", "help me write section X of a trial protocol", or "calculate the sample size for this trial". Produces a stakeholder-ready Markdown deliverable, not a feasibility score.
skills/tooluniverse-clinical-trial-protocol/SKILL.md
Source commit 5598a9fc97e32964fe9b703818e7d0747142f179
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- Network or broad shell
- Last checked
- Nov 5, 2026
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- Repository stars (not skill ratings)
- 1,777
- Repository last updated
- Nov 7, 2026
- License
- Apache-2.0
Observed agent integration: No specific integration evidence. Standard SKILL.md installation does not imply verified compatibility.
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SKILL.mdcore · 8,031 bytesSKILL.mdcore · 8,031 bytesreferences/protocol_sections_guide.mddoc · 4,641 bytesreferences/regulatory_pathway_notes.mddoc · 3,112 bytesscripts/sample_size_calculator.pyruns · 11,093 bytestemplates/protocol_template.mddoc · 3,115 bytes
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# Clinical Trial Protocol Generation
Turns a trial concept into an actual protocol DOCUMENT, grounded in real precedent-trial and regulatory-database lookups plus a genuine statistical sample-size calculation.
**This skill is a downstream step, not a replacement for `tooluniverse-clinical-trial-design`.** That skill answers "is this trial feasible, and what should endpoint/population/comparator/effect-size/duration/regulatory-pathway be?" (a 0-100 feasibility score with evidence grading). This skill takes those six answers — freshly run or already available from a prior `tooluniverse-clinical-trial-design` report — and drafts the actual protocol sections around them. **Do not re-derive feasibility scoring, endpoint selection reasoning, or regulatory-pathway strategy here — call `tooluniverse-clinical-trial-design` for that and consume its output.**
## When to Use This Skill
- "Write me a clinical trial protocol for [drug/device]"
- "Generate an FDA submission protocol for our Phase 2 study"
- "Draft the statistical analysis plan / sample size section"
- "I have the feasibility assessment — now turn it into a protocol document"
- "What sample size do I need for a [proportion/continuous/survival] endpoint?"
