clinical-reports

Generates clinical reports including CARE-compliant templates for multiple medical documentation types.

4|1|Updated Apr 8, 2026

Search Tags:#validation #reporting #fda #clinical #hipaa #ich-e3 #care-guidelines

Ready to run

npx skills add https://github.com/ARAVINDAN20/Claude-Research-Paper-OS --skill clinical-reports-aravindan20

💬 Prompt for ChatGPT / Claude Chat▼

Please help me install this Agent Skill.
Skill: clinical-reports
Source: https://github.com/ARAVINDAN20/Claude-Research-Paper-OS/tree/main/.claude/skills/claude-scientific-writer/.claude/skills/clinical-reports
Command: npx skills add https://github.com/ARAVINDAN20/Claude-Research-Paper-OS --skill clinical-reports-aravindan20

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill includes scripts (resource) and references (resource) and assets (resource) components.

What problem does it solve?

Clinical-reports provides a complete framework for producing high-quality clinical documents across CARE case reports, diagnostic/radiology/pathology/lab reports, clinical study reports, and patient documentation, with built-in templates, regulatory guidance, and validation tools to ensure privacy and compliance.

Core Features & Use Cases

Four major report types: case reports, diagnostic reports, clinical trial reports, and patient documentation
8 comprehensive reference guides, 12 professional templates, and 8 validation scripts
HIPAA privacy, FDA regulatory requirements, ICH-GCP alignment, and ALCOA data integrity practices
Seamless integration with existing Claude skills for medical writing, peer review, and literature management
Real-world workflows for publishing, clinical documentation, and regulatory submissions
Supports YAML frontmatter conformance in SKILL.md and on-demand loading from scripts/, references/, and assets/

Quick Start

Load the clinical-reports skill in Claude Code and generate a case report template using the built-in generator.

Frequently Asked Questions about clinical-reports

High-intent search queries and answers about installing and using this skill.

FAQPage Schema

How do I generate HIPAA compliant clinical study reports?▼

To generate HIPAA compliant clinical study reports, this framework applies automatic de-identification to patient data and aligns with ICH-GCP standards. It produces CSR and SAE documents validated for regulatory submissions using built-in templates.

Can I use built-in templates for diagnostic radiology and pathology reporting?▼

Yes, you can use built-in templates for diagnostic radiology and pathology reporting. The framework provides twelve professional templates covering diagnostic, lab, CARE case reports, and SOAP/H&P documentation for clinical and research contexts.

What is the best way to validate clinical reports for FDA regulatory submissions?▼

The best way to validate clinical reports for FDA submissions is running the eight included validation scripts. These scripts enforce ALCOA data integrity practices and verify HIPAA de-identification, ensuring your documentation meets regulatory requirements.

Does this clinical reporting framework support CARE case report guidelines?▼

Yes, this clinical reporting framework fully supports CARE case report guidelines. It generates compliant case reports alongside clinical study reports and patient documentation, applying HIPAA privacy rules and ICH-GCP alignment for publication readiness.

How do I create SOAP and H&P notes for clinical documentation?▼

You create SOAP and H&P notes for clinical documentation by loading the framework and selecting the patient documentation template. It structures subjective, objective, assessment, and plan data while applying HIPAA de-identification for privacy compliance.

What are the limitations of automated clinical report generation for regulatory submissions?▼

Automated clinical report generation requires manual review before regulatory submission despite built-in validation scripts. While templates enforce ICH-GCP and ALCOA practices, final FDA compliance verification and HIPAA de-identification accuracy must be confirmed by clinical professionals.