clinical-trial-protocol-skill
anthropics/healthcareOfficial collectionScience & research
clinical-trial-protocol-skill is a skill in anthropics/healthcare, last changed 15 Jun 2026. It can run shell commands, reach the network, name web addresses and bundle scripts — read the findings before installing.
Generate clinical trial protocols for medical devices or drugs. This skill should be used when users say "Create a clinical trial protocol", "Generate protocol for [device/drug]", "Help me design a clinical study", "Research similar trials for [intervention]", or when developing FDA submission documentation for investigational products.
At a glance
What it can touch
How much a skill can do, not whether it is risky.
Pattern check
Nothing flagged
That isn't proof the skill is harmless.
Commit c7ed150 · 1 Nov 2026
How the check worksPattern check: nothing flagged
That isn't proof the skill is harmless.
Install
Each tab says whether it installs commit c7ed150, the one we checked, or the latest version.
OpenCode also looks in .agents/skills/ and ~/.agents/skills/, so use the Any agent steps.
Goose also looks in .agents/skills/ and ~/.agents/skills/, so use the Any agent steps.
Windsurf (Devin Desktop) also looks in .agents/skills/ and ~/.agents/skills/, so use the Any agent steps.
Zed also looks in .agents/skills/ and ~/.agents/skills/, so use the Any agent steps.
Roo Code also looks in .agents/skills/ and ~/.agents/skills/, so use the Any agent steps.
Factory Droid also looks in .agents/skills/ and ~/.agents/skills/, so use the Any agent steps.
Junie also looks in .agents/skills/ and ~/.agents/skills/, so use the Any agent steps.
Amp also looks in .agents/skills/ and ~/.agents/skills/, so use the Any agent steps.
No install command here reaches Kiro. Copy the skill's folder into .kiro/skills/ in your project, or ~/.kiro/skills/ for all your projects. anthropics/healthcare/plugins/healthcare/skills/clinical-trial-protocol (opens in a new tab)
Antigravity also looks in .agents/skills/, so the Any agent steps reach it with This project. For All projects, see where Antigravity looks.
Cline also looks in .claude/skills/, so the Claude Code steps reach it with This project. For All projects, see where Cline looks.
Claude Code
Pinned to commit c7ed150, the one we checked.
From your project's root folder:
tmp="$(mktemp -d)" &&git clone -q --depth 1 --filter=blob:none --no-checkout https://github.com/anthropics/healthcare.git "$tmp" &&git -C "$tmp" fetch -q --depth 1 origin c7ed150d376bdd13219eb0bfeb4203e12da85516 &&git -C "$tmp" sparse-checkout set -- plugins/healthcare/skills/clinical-trial-protocol &&git -C "$tmp" checkout -q c7ed150d376bdd13219eb0bfeb4203e12da85516 &&mkdir -p .claude/skills &&mkdir .claude/skills/clinical-trial-protocol-skill &&cp -R "$tmp"/plugins/healthcare/skills/clinical-trial-protocol/. .claude/skills/clinical-trial-protocol-skill/ &&rm -rf "$tmp"If Claude Code was already running and this created the skills folder, run /reload-skills.
Or install the healthcare plugin it ships in. Installs the latest version, not the one we checked. Installs everything in the plugin, including any hooks, MCP servers and scripts our check doesn't cover.
claude plugin marketplace add anthropics/healthcare --scope project &&claude plugin install healthcare@healthcare --scope projectClaude apps
Pinned to commit c7ed150, the one we checked.
Skills in the Claude apps belong to your account rather than to a project.
Make clinical-trial-protocol-skill.zip, with the skill folder at the top level:
tmp="$(mktemp -d)" &&git clone -q --depth 1 --filter=blob:none --no-checkout https://github.com/anthropics/healthcare.git "$tmp" &&git -C "$tmp" fetch -q --depth 1 origin c7ed150d376bdd13219eb0bfeb4203e12da85516 &&git -C "$tmp" sparse-checkout set -- plugins/healthcare/skills/clinical-trial-protocol &&git -C "$tmp" checkout -q c7ed150d376bdd13219eb0bfeb4203e12da85516 &&out="$(mktemp -d)" &&cp -R "$tmp"/plugins/healthcare/skills/clinical-trial-protocol "$out"/clinical-trial-protocol-skill &&(cd "$out" && zip -qr - clinical-trial-protocol-skill) > clinical-trial-protocol-skill.zip &&rm -rf "$tmp" "$out"In Claude, open Customize > Skills, select +, then + Create skill > Upload a skill, and choose clinical-trial-protocol-skill.zip.
On Free, Pro and Max plans, turn on Code execution and file creation (Create and edit files in newer settings) under Settings > Capabilities.
Codex
Pinned to commit c7ed150, the one we checked.
From your project's root folder:
tmp="$(mktemp -d)" &&git clone -q --depth 1 --filter=blob:none --no-checkout https://github.com/anthropics/healthcare.git "$tmp" &&git -C "$tmp" fetch -q --depth 1 origin c7ed150d376bdd13219eb0bfeb4203e12da85516 &&git -C "$tmp" sparse-checkout set -- plugins/healthcare/skills/clinical-trial-protocol &&git -C "$tmp" checkout -q c7ed150d376bdd13219eb0bfeb4203e12da85516 &&mkdir -p .agents/skills &&mkdir .agents/skills/clinical-trial-protocol-skill &&cp -R "$tmp"/plugins/healthcare/skills/clinical-trial-protocol/. .agents/skills/clinical-trial-protocol-skill/ &&rm -rf "$tmp"Codex picks up new skills on its own; restart it if this one does not appear.
Cursor
Pinned to commit c7ed150, the one we checked.
From your project's root folder:
tmp="$(mktemp -d)" &&git clone -q --depth 1 --filter=blob:none --no-checkout https://github.com/anthropics/healthcare.git "$tmp" &&git -C "$tmp" fetch -q --depth 1 origin c7ed150d376bdd13219eb0bfeb4203e12da85516 &&git -C "$tmp" sparse-checkout set -- plugins/healthcare/skills/clinical-trial-protocol &&git -C "$tmp" checkout -q c7ed150d376bdd13219eb0bfeb4203e12da85516 &&mkdir -p .cursor/skills &&mkdir .cursor/skills/clinical-trial-protocol-skill &&cp -R "$tmp"/plugins/healthcare/skills/clinical-trial-protocol/. .cursor/skills/clinical-trial-protocol-skill/ &&rm -rf "$tmp"Copilot & VS Code
Pinned to commit c7ed150, the one we checked.
From your project's root folder:
tmp="$(mktemp -d)" &&git clone -q --depth 1 --filter=blob:none --no-checkout https://github.com/anthropics/healthcare.git "$tmp" &&git -C "$tmp" fetch -q --depth 1 origin c7ed150d376bdd13219eb0bfeb4203e12da85516 &&git -C "$tmp" sparse-checkout set -- plugins/healthcare/skills/clinical-trial-protocol &&git -C "$tmp" checkout -q c7ed150d376bdd13219eb0bfeb4203e12da85516 &&mkdir -p .github/skills &&mkdir .github/skills/clinical-trial-protocol-skill &&cp -R "$tmp"/plugins/healthcare/skills/clinical-trial-protocol/. .github/skills/clinical-trial-protocol-skill/ &&rm -rf "$tmp"In a running Copilot CLI session, run /skills reload.
Or install it with gh skill, which also installs the commit we checked. Needs GitHub CLI 2.90 or later.
gh skill install anthropics/healthcare plugins/healthcare/skills/clinical-trial-protocol/SKILL.md@c7ed150d376bdd13219eb0bfeb4203e12da85516 --agent github-copilot --scope projectGemini CLI
Pinned to commit c7ed150, the one we checked.
From your project's root folder:
tmp="$(mktemp -d)" &&git clone -q --depth 1 --filter=blob:none --no-checkout https://github.com/anthropics/healthcare.git "$tmp" &&git -C "$tmp" fetch -q --depth 1 origin c7ed150d376bdd13219eb0bfeb4203e12da85516 &&git -C "$tmp" sparse-checkout set -- plugins/healthcare/skills/clinical-trial-protocol &&git -C "$tmp" checkout -q c7ed150d376bdd13219eb0bfeb4203e12da85516 &&mkdir -p .gemini/skills &&mkdir .gemini/skills/clinical-trial-protocol-skill &&cp -R "$tmp"/plugins/healthcare/skills/clinical-trial-protocol/. .gemini/skills/clinical-trial-protocol-skill/ &&rm -rf "$tmp"In a running session, run /skills reload.
Or use Gemini CLI’s own installer. Installs the latest version, not the one we checked.
gemini skills install https://github.com/anthropics/healthcare.git --path plugins/healthcare/skills/clinical-trial-protocol --scope workspaceAny agent
Pinned to commit c7ed150, the one we checked.
OpenCode, Goose, Windsurf (Devin Desktop), Zed, Roo Code, Factory Droid, Junie, Amp and Antigravity read .agents/skills in a project.
From your project's root folder:
tmp="$(mktemp -d)" &&git clone -q --depth 1 --filter=blob:none --no-checkout https://github.com/anthropics/healthcare.git "$tmp" &&git -C "$tmp" fetch -q --depth 1 origin c7ed150d376bdd13219eb0bfeb4203e12da85516 &&git -C "$tmp" sparse-checkout set -- plugins/healthcare/skills/clinical-trial-protocol &&git -C "$tmp" checkout -q c7ed150d376bdd13219eb0bfeb4203e12da85516 &&mkdir -p .agents/skills &&mkdir .agents/skills/clinical-trial-protocol-skill &&cp -R "$tmp"/plugins/healthcare/skills/clinical-trial-protocol/. .agents/skills/clinical-trial-protocol-skill/ &&rm -rf "$tmp"Or use the skills CLI from skills.sh. Installs the latest version, not the one we checked. The skills CLI reports installs to skills.sh unless you set DISABLE_TELEMETRY=1.
npx skills@1.7.4 add anthropics/healthcare --skill clinical-trial-protocol-skillWhat it can touch
From the files and frontmatter at commit c7ed150. This is how much a skill can do, not whether it is risky.
Pattern check
Pattern check: nothing flagged · commit c7ed150 · 1 Nov 2026
We checked every text file in this skill, at commit c7ed150 on 1 Nov 2026, against 45 published patterns such as download-and-run commands, hidden text and credential access. We don't run the skill, we don't read the web pages it points to, and we can't judge everything its instructions might lead an agent to do. In published tests, pattern checks like this one missed most malicious skills. Read the skill before you install it — especially anything it asks you to download or run.
How the check worksReport an incorrect finding
Outside links we did not follow
- https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia/
- https://www.ecfr.gov/cgi-bin/text-idx?SID=007006046b07c9fc5244ec13ef4a77bb&mc=true&node=pt21.1.11&rgn=div5
- https://www.ecfr.gov/cgi-bin/text-idx?SID=6d82202a67ba5bd44148d99f4aaf7198&mc=true&node=pt21.1.50&rgn=div5
- https://www.ecfr.gov/cgi-bin/text-idx?SID=bae2d66180fd49cb11f40a935cd760a7&mc=true&node=pt21.1.54&rgn=div5
- https://www.ecfr.gov/cgi-bin/text-idx?SID=64724709940d94a34270c77fdb8d307f&mc=true&node=pt21.1.56&rgn=div5
- http://www.ecfr.gov/cgi-bin/text-idx?SID=90f8b344173d4c43e0c515d0a0cbc4de&mc=true&node=pt21.1.58&rgn=div5
- http://www.ecfr.gov/cgi-bin/text-idx?SID=90f8b344173d4c43e0c515d0a0cbc4de&mc=true&node=pt21.4.210&rgn=div5
- http://www.ecfr.gov/cgi-bin/text-idx?SID=90f8b344173d4c43e0c515d0a0cbc4de&mc=true&node=pt21.4.211&rgn=div5
- https://www.ecfr.gov/cgi-bin/text-idx?SID=27a0c0825d11663283856731fb14c8d2&mc=true&node=pt21.5.312&rgn=div5
- https://www.ecfr.gov/cgi-bin/text-idx?SID=0f8fa3b740966b3d21d5501233e2b493&mc=true&node=pt21.8.812&rgn=div5
Show 40 more
- https://www.gpo.gov/fdsys/pkg/CFR-2016-title42-vol1/pdf/CFR-2016-title42-vol1-part11.pdf
- http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
- http://www.fda.gov/ICECI/EnforcementActions/default.htm
- http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm155713.htm
- http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126572.pdf
- http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm127073.pdf
- https://www.fda.gov/downloads/Drugs/.../Guidances/ucm073122.pdf
- http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm328691.pdf
- https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM536750.pdf
- http://www.fda.gov/downloads/Drugs/Guidances/UCM269919.pdf
- http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM333969.pdf
- http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM292334.pdf
- http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm477584.pdf
- http://www.hhs.gov/hipaa/for-professionals/privacy/
- https://www.hhs.gov/hipaa/for-professionals/special-topics/research/index.html
- http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM464506.pdf
- http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073246.pdf
- http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073113.pdf
- http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073137.pdf
- http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/E9__R1__Final_Concept_Paper_October_23_2014.pdf
- https://www.iso.org/obp/ui/%20-%20iso:std:iso:14155:ed-2:v1:en
- http://grants.nih.gov/grants/policy/coc/index.htm
- https://www.federalregister.gov/documents/2016/09/21/2016-22129/clinical-trials-registration-and-results-information-submission
- http://grants.nih.gov/grants/policy/coi/
- https://grants.nih.gov/grants/funding/children/children.htm
- http://grants.nih.gov/grants/funding/women_min/women_min.htm
- http://grants.nih.gov/policy/sharing.htm
- http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm
- https://gds.nih.gov/03policy2.html
- http://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.2_availability_of_research_results_publications__intellectual_property_rights__and_sharing_research_resources.htm
- https://www.gpo.gov/fdsys/pkg/FR-2016-09-21/pdf/2016-22379.pdf
- http://publicaccess.nih.gov/policy.htm
- https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html
- http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-061.html
- http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html
- http://www.hhs.gov/ohrp/policy/consentckls.html
- http://www.hhs.gov/ohrp/policy/ictips.html
- http://www.hhs.gov/ohrp/assurances/
- http://www.hhs.gov/ohrp/regulations-and-policy/index.html
- http://www.hhs.gov/ohrp/regulations-and-policy/guidance/reviewing-unanticipated-problems/index.html
Format check
Each agent reads SKILL.md a little differently. We check the file against each one's published rules; we don't run the skill in any agent.
Agent Skills specFails
The open format from agentskills.io, held to what the strictest agents enforce, so one folder loads everywhere.
- Error
The name "clinical-trial-protocol-skill" doesn't match its folder "clinical-trial-protocol". The spec requires them to match. N4
Fix: Set name: clinical-trial-protocol, or rename the folder to clinical-trial-protocol-skill.
- Warning
The body is 501 lines; the spec suggests under 500. B1
Fix: Move detailed sections into reference files and link to them from SKILL.md.
- Note
There is no license field, so readers can't tell whether they may reuse the skill. O2
Fix: Add license: with an SPDX name such as MIT or Apache-2.0, or the name of a bundled licence file.
- Note
Reference files over 100 lines with no table of contents at the top: references/00-initialize-intervention.md (201 lines), references/01-research-protocols.md (415 lines), references/02-protocol-foundation.md (837 lines), references/03-protocol-intervention.md (742 lines), references/04-protocol-operations.md (1889 lines) and 1 more. B5
Fix: Add a short list of the sections at the top of each.
- Error
Claude CodePasses
Claude Code reads its own extra fields, ignores unknown ones, and still loads a skill whose frontmatter is broken, without its fields.
- Note
The name "clinical-trial-protocol-skill" doesn't match its folder "clinical-trial-protocol". Claude Code shows the skill as /clinical-trial-protocol-skill, and the folder name also invokes it. N4
Fix: Set name: clinical-trial-protocol, or rename the folder to clinical-trial-protocol-skill.
- Note
The body is 501 lines; the spec suggests under 500. Claude Code's docs say the same. B1
Fix: Move detailed sections into reference files and link to them from SKILL.md.
- Note
Reference files over 100 lines with no table of contents at the top: references/00-initialize-intervention.md (201 lines), references/01-research-protocols.md (415 lines), references/02-protocol-foundation.md (837 lines), references/03-protocol-intervention.md (742 lines), references/04-protocol-operations.md (1889 lines) and 1 more. B5
Fix: Add a short list of the sections at the top of each.
- Note
Claude apps & API uploadFails
Uploading to claude.ai or the Claude API, or packaging with Anthropic's script, accepts only the six spec fields and stops on anything else.
- Error
The name "clinical-trial-protocol-skill" doesn't match its folder "clinical-trial-protocol". claude.ai refuses an upload whose folder name doesn't match the skill name. N4
Fix: Set name: clinical-trial-protocol, or rename the folder to clinical-trial-protocol-skill.
- Note
The description is 338 characters. The claude.ai Help Center says 200 at most, though Anthropic's API docs and validator allow 1,024. D4
Fix: If the claude.ai upload refuses it, trim the description to 200 characters.
- Note
The body is 501 lines; the spec suggests under 500. Anthropic's guidance says the same. B1
Fix: Move detailed sections into reference files and link to them from SKILL.md.
- Note
Reference files over 100 lines with no table of contents at the top: references/00-initialize-intervention.md (201 lines), references/01-research-protocols.md (415 lines), references/02-protocol-foundation.md (837 lines), references/03-protocol-intervention.md (742 lines), references/04-protocol-operations.md (1889 lines) and 1 more. B5
Fix: Add a short list of the sections at the top of each.
- Error
OpenAI (Codex & API)Passes with warnings
Codex finds SKILL.md by its exact name and needs a description; OpenAI's Skills API checks the frontmatter against the spec and caps uploads.
- Warning
The name "clinical-trial-protocol-skill" doesn't match its folder "clinical-trial-protocol". OpenAI's own upload example uses a differently named folder, but the spec it follows says they must match. N4
Fix: Set name: clinical-trial-protocol, or rename the folder to clinical-trial-protocol-skill.
- Warning
VS Code & CopilotPasses with warnings
VS Code reads skills one folder below .github/skills, .claude/skills or .agents/skills and falls back to the folder name when the name is missing or differs; GitHub's Copilot docs require the exact name SKILL.md.
- Warning
The name "clinical-trial-protocol-skill" doesn't match its folder "clinical-trial-protocol". VS Code uses the folder name, clinical-trial-protocol, instead. N4
Fix: Set name: clinical-trial-protocol, or rename the folder to clinical-trial-protocol-skill.
- Warning
SKILL.md
We only show SKILL.md text here when its licence clearly allows it.
Read SKILL.md on GitHub (opens in a new tab)Files
10 files
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