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Generate clinical trial protocols and research similar studies for interventions.
Copy the install command and let the AI configure it · recommended for beginners
Please install the "clinical-trial-protocol-skill" skill from askskill: 1. Download https://raw.githubusercontent.com/anthropics/life-sciences/main/clinical-trial-protocol-skill/SKILL.md 2. Save it as ~/.claude/skills/clinical-trial-protocol-skill/SKILL.md 3. Reload skills and tell me it's ready
Create a clinical trial protocol for a novel oral drug for type 2 diabetes, including objectives, study design, eligibility criteria, intervention, endpoints, safety monitoring, and statistical considerations.
A structured draft clinical trial protocol covering key sections for stakeholder review.
Help me design a clinical study protocol for a wearable ECG monitoring device, including population, assessments, operational workflow, and data analysis framework.
A draft clinical study protocol for the device, emphasizing design, assessments, and operational planning.
First research similar clinical trials, FDA guidance, and published protocols for an oncology drug, then compile a research summary.
A compiled research summary of similar trials and regulatory references for later protocol drafting.
Researchers can begin by collecting intervention details and researching similar trials, FDA guidance, and published protocols before a drug or device project starts. This creates a reference summary for later study design.
When a team needs a complete clinical trial protocol, this skill can generate foundation sections, intervention details, and assessments, statistics, and operations in stages, then assemble them into a review-ready file. It applies to both drugs and medical devices.
When developing FDA submission documentation for investigational products, teams can use it to organize similar research and regulatory references first, then produce a more structured protocol draft. This supports stakeholder review and internal collaboration.
The documentation describes a clinical trial protocol generation skill for drugs and medical devices built with a modular, waypoint-based workflow. It supports a research-only mode for similar trials, FDA guidance, and published protocol review, as well as a full protocol mode that develops protocol sections in stages and assembles a review-ready file. It also outlines how intermediate outputs are stored as JSON and Markdown artifacts for reuse across steps.
CRITICAL: This orchestrator follows a SIMPLE START approach:
Why this matters:
This skill generates clinical trial protocols for medical devices or drugs using a modular, waypoint-based architecture
Starting with an intervention idea (device or drug), this orchestrated workflow offers two modes:
🔬 Research Only Mode (Steps 0-1): 0. Initialize Intervention - Collect device or drug information
📄 Full Protocol Mode (Steps 0-5): 0. Initialize Intervention - Collect device or drug information
All analysis data is stored in waypoints/ directory as JSON/markdown files:
waypoints/
├── intervention_metadata.json # Intervention info, status, initial context
├── 01_clinical_research_summary.json # Similar trials, FDA guidance, recommendations
├── 02_protocol_foundation.md # Protocol sections 1-6 (Step 2)
├── 03_protocol_intervention.md # Protocol sections 7-8 (Step 3)
├── 04_protocol_operations.md # Protocol sections 9-12 (Step 4)
├── 02_protocol_draft.md # Complete protocol (concatenated in Step 4)
├── 02_protocol_metadata.json # Protocol metadata
└── 02_sample_size_calculation.json # Statistical sample size calculation
Rich Initial Context Support:
Users can provide substantial documentation, technical specifications, or research data when initializing the intervention (Step 0). This is preserved in intervention_metadata.json under the initial_context field. Later steps reference this context for more informed protocol development.
Each step is an independent skill in references/ directory:
references/
├── 00-initialize-intervention.md # Collect device or drug information
├── 01-research-protocols.md # Clinical trials research and FDA guidance
├── 02-protocol-foundation.md # Protocol sections 1-6 (foundation, design, population)
├── 03-protocol-intervention.md # Protocol sections 7-8 (intervention details)
├── 04-protocol-operations.md # Protocol sections 9-12 (assessments, statistics, operations)
└── 05-generate-document.md # NIH Protocol generation
scripts/
└── sample_size_calculator.py # Statistical power analysis (validated)
Installation:
.mcpb file into Claude DesktopAvailable Tools:
search_clinical_trials - Search by:
condition - Disease or condition (e.g., "pancreatic cancer")
…
It is used to generate clinical trial protocols for drugs or medical devices, and it can also research similar trials, FDA guidance, and published protocols first. The documentation describes both a research-only mode and a full protocol mode.
Based on the provided material, it includes staged steps from intervention initialization and similar-trial research to protocol foundation, intervention content, operations/statistics, and final protocol generation. Research mode produces a research summary, while full mode creates a review-ready protocol file.
The excerpt mainly describes the workflow and file structure, and it does not clearly list installation, API key, or runtime requirements. For specific setup details, see the source repository.
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