How to use the Clinical Trial Protocol Draft Generation sample skill with Claude

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Life Sciences
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What is the Clinical Trial Protocol Draft Generation demo skill?

The Clinical Trial Protocol Draft Generation demo skill digests initial documentation about a new medical device or investigational drug, and follows regulatory guidelines to generate an initial phase 2 or 3 trial protocol draft. It does this by:

Searching for relevant FDA guidances to determine classification & pathway
Reviews OpenFDA and ClinicalTrials.gov for predicate devices and similar trials
Uses a statistically significant sample size calculator to the determine treatment arm
Drafts an initial full protocol following the formal FDA/NIH template for IND & IVD protocols

This is a sample skill that gives you a starting point to customize for your own use cases. Be sure to review the README.md file before using the skill.

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Who should use the Clinical Trial Protocol Draft Generation demo skill?

This skill is designed for regulatory affairs professionals at pharmaceutical and medical device companies who need to draft clinical trial protocols and determine their regulatory pathway without writing code from scratch.

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How to access the skill in Claude.ai

For Organization Owners (Team and Enterprise)

Download the ZIP for the clinical-trial-protocol-skill here‍
Review the sample skill thoroughly and make edits and adjustments to fit your organization’s workflows
From Claude.ai, navigate to Admin settings > Capabilities > Skills
Make sure Skills is activated for your organization
Click “Organization skills library”
Click “+Add”
Upload the skill zip file

Learn about provisioning and managing skills for your organization

For Individual Claude Users

Download the ZIP file for clinical-trial-protocol-skill here
Review the sample skill thoroughly and make edits and adjustments to fit your workflow
From Claude.ai, navigate to Settings > Capabilities > Skills (if Skills is not available, contact your team admin)
Click “Upload skill”
Upload the skill zip file

How to access the skill in Claude Code

Command

/plugin marketplace add anthropics/life-sciences

/plugin install clinical-trial-protocol@life-sciences

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Help me develop a unique voice for an audience
Hi Claude! Could you help me develop a unique voice for an audience? If you need more information from me, ask me 1-2 key questions right away. If you think I should upload any documents that would help you do a better job, let me know. You can use the tools you have access to— like Google Drive, web search, etc.—if they’ll help you better accomplish this task. Do not use analysis tool. Please keep your responses friendly, brief and conversational.

Please execute the task as soon as you can—an artifact would be great if it makes sense. If using an artifact, consider what kind of artifact (interactive, visual, checklist, etc.) might be most helpful for this specific task. Thanks for your help!
Improve my writing style
Hi Claude! Could you improve my writing style? If you need more information from me, ask me 1-2 key questions right away. If you think I should upload any documents that would help you do a better job, let me know. You can use the tools you have access to— like Google Drive, web search, etc.—if they’ll help you better accomplish this task. Do not use analysis tool. Please keep your responses friendly, brief and conversational.

Please execute the task as soon as you can—an artifact would be great if it makes sense. If using an artifact, consider what kind of artifact (interactive, visual, checklist, etc.) might be most helpful for this specific task. Thanks for your help!
Brainstorm creative ideas
Hi Claude! Could you brainstorm creative ideas? If you need more information from me, ask me 1-2 key questions right away. If you think I should upload any documents that would help you do a better job, let me know. You can use the tools you have access to— like Google Drive, web search, etc.—if they’ll help you better accomplish this task. Do not use analysis tool. Please keep your responses friendly, brief and conversational.

Please execute the task as soon as you can—an artifact would be great if it makes sense. If using an artifact, consider what kind of artifact (interactive, visual, checklist, etc.) might be most helpful for this specific task. Thanks for your help!

Learn

Explain a complex topic simply
Hi Claude! Could you explain a complex topic simply? If you need more information from me, ask me 1-2 key questions right away. If you think I should upload any documents that would help you do a better job, let me know. You can use the tools you have access to— like Google Drive, web search, etc.—if they’ll help you better accomplish this task. Do not use analysis tool. Please keep your responses friendly, brief and conversational.

Please execute the task as soon as you can—an artifact would be great if it makes sense. If using an artifact, consider what kind of artifact (interactive, visual, checklist, etc.) might be most helpful for this specific task. Thanks for your help!
Help me make sense of these ideas
Hi Claude! Could you help me make sense of these ideas? If you need more information from me, ask me 1-2 key questions right away. If you think I should upload any documents that would help you do a better job, let me know. You can use the tools you have access to— like Google Drive, web search, etc.—if they’ll help you better accomplish this task. Do not use analysis tool. Please keep your responses friendly, brief and conversational.

Please execute the task as soon as you can—an artifact would be great if it makes sense. If using an artifact, consider what kind of artifact (interactive, visual, checklist, etc.) might be most helpful for this specific task. Thanks for your help!
Prepare for an exam or interview
Hi Claude! Could you prepare for an exam or interview? If you need more information from me, ask me 1-2 key questions right away. If you think I should upload any documents that would help you do a better job, let me know. You can use the tools you have access to— like Google Drive, web search, etc.—if they’ll help you better accomplish this task. Do not use analysis tool. Please keep your responses friendly, brief and conversational.

Please execute the task as soon as you can—an artifact would be great if it makes sense. If using an artifact, consider what kind of artifact (interactive, visual, checklist, etc.) might be most helpful for this specific task. Thanks for your help!

Code

Explain a programming concept
Hi Claude! Could you explain a programming concept? If you need more information from me, ask me 1-2 key questions right away. If you think I should upload any documents that would help you do a better job, let me know. You can use the tools you have access to— like Google Drive, web search, etc.—if they’ll help you better accomplish this task. Do not use analysis tool. Please keep your responses friendly, brief and conversational.

Please execute the task as soon as you can—an artifact would be great if it makes sense. If using an artifact, consider what kind of artifact (interactive, visual, checklist, etc.) might be most helpful for this specific task. Thanks for your help!
Look over my code and give me tips
Hi Claude! Could you look over my code and give me tips? If you need more information from me, ask me 1-2 key questions right away. If you think I should upload any documents that would help you do a better job, let me know. You can use the tools you have access to— like Google Drive, web search, etc.—if they’ll help you better accomplish this task. Do not use analysis tool. Please keep your responses friendly, brief and conversational.

Please execute the task as soon as you can—an artifact would be great if it makes sense. If using an artifact, consider what kind of artifact (interactive, visual, checklist, etc.) might be most helpful for this specific task. Thanks for your help!
Vibe code with me
Hi Claude! Could you vibe code with me? If you need more information from me, ask me 1-2 key questions right away. If you think I should upload any documents that would help you do a better job, let me know. You can use the tools you have access to— like Google Drive, web search, etc.—if they’ll help you better accomplish this task. Do not use analysis tool. Please keep your responses friendly, brief and conversational.

Please execute the task as soon as you can—an artifact would be great if it makes sense. If using an artifact, consider what kind of artifact (interactive, visual, checklist, etc.) might be most helpful for this specific task. Thanks for your help!

Write case studies
This is another test
Write grant proposals
Hi Claude! Could you write grant proposals? If you need more information from me, ask me 1-2 key questions right away. If you think I should upload any documents that would help you do a better job, let me know. You can use the tools you have access to — like Google Drive, web search, etc. — if they’ll help you better accomplish this task. Do not use analysis tool. Please keep your responses friendly, brief and conversational.

Please execute the task as soon as you can - an artifact would be great if it makes sense. If using an artifact, consider what kind of artifact (interactive, visual, checklist, etc.) might be most helpful for this specific task. Thanks for your help!
Write video scripts
this is a test

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