Can I resume a protocol generation if I stop midway?

Yes, the skill uses a waypoint-based design that saves progress in a local directory, allowing you to resume exactly where you left off.

What interventions does this skill support?

The skill is specifically designed to generate protocols for both medical devices and pharmaceutical drugs.

How does it handle statistical calculations?

The skill includes a validated Python script that uses scipy and numpy to perform accurate statistical power analysis and sample size calculations.

Does this skill require external data access?

Yes, it requires a clinical trials MCP server and utilizes direct FDA database URLs to ensure research is based on current regulatory data.

Clinical Trial Protocol Architect

Name: Clinical Trial Protocol Architect
Author: anthropics

byanthropics

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147

生产力与工作流

Generates comprehensive clinical trial protocols for medical devices and drugs using automated research and statistical validation.

关于

This skill automates the complex process of designing clinical studies by integrating FDA regulatory research, clinical trial database analysis, and NIH-standard protocol generation. It features a modular, waypoint-based architecture that allows users to research similar trials, calculate statistical sample sizes, and generate production-ready documentation for investigational products. By streamlining the path from intervention concept to full protocol draft, it significantly reduces the manual effort required for high-stakes regulatory submissions and study design.

主要功能

147 GitHub stars
Modular, waypoint-based workflow for process persistence and resumption
Automated research of similar clinical trials via MCP integration
NIH-standard protocol generation for drugs and medical devices
Direct FDA database lookup for regulatory pathways and guidance
Validated statistical sample size calculations using Python scripts

使用场景

Conducting competitive research on existing clinical trial protocols and FDA guidance
Generating standardized FDA submission documentation for investigational products
Designing an early-phase clinical trial for a new medical device

关于

主要功能

147 GitHub stars
Modular, waypoint-based workflow for process persistence and resumption
Automated research of similar clinical trials via MCP integration
NIH-standard protocol generation for drugs and medical devices
Direct FDA database lookup for regulatory pathways and guidance
Validated statistical sample size calculations using Python scripts

使用场景

Conducting competitive research on existing clinical trial protocols and FDA guidance
Generating standardized FDA submission documentation for investigational products
Designing an early-phase clinical trial for a new medical device