Comprehensive skill for writing clinical reports including case reports, diagnostic reports, clinical trial reports, and patient documentation. Provides full support with templates, regulatory compliance, and validation tools.

What's Included

📋 Four Major Report Types

Clinical Case Reports - CARE-compliant case reports for medical journal publication
Diagnostic Reports - Radiology (ACR), pathology (CAP), and laboratory reports
Clinical Trial Reports - SAE reports, Clinical Study Reports (ICH-E3), DSMB reports
Patient Documentation - SOAP notes, H&P, discharge summaries, consultation notes

📚 Reference Files (8 comprehensive guides)

case_report_guidelines.md - CARE guidelines, de-identification, journal requirements
diagnostic_reports_standards.md - ACR, CAP, CLSI standards, structured reporting systems
clinical_trial_reporting.md - ICH-E3, CONSORT, SAE reporting, MedDRA coding
patient_documentation.md - SOAP notes, H&P, discharge summary standards
regulatory_compliance.md - HIPAA, 21 CFR Part 11, ICH-GCP, FDA regulations
medical_terminology.md - SNOMED-CT, LOINC, ICD-10, CPT codes
data_presentation.md - Clinical tables, figures, Kaplan-Meier curves
peer_review_standards.md - Review criteria for clinical manuscripts

📄 Templates (12 professional templates)

case_report_template.md - Structured case report following CARE guidelines
soap_note_template.md - SOAP progress note format
history_physical_template.md - Complete H&P examination template
discharge_summary_template.md - Hospital discharge documentation
consult_note_template.md - Specialist consultation format
radiology_report_template.md - Imaging report with structured reporting
pathology_report_template.md - Surgical pathology with CAP synoptic elements
lab_report_template.md - Clinical laboratory test results
clinical_trial_sae_template.md - Serious adverse event report form
clinical_trial_csr_template.md - Clinical study report outline (ICH-E3)
quality_checklist.md - Quality assurance for all report types
hipaa_compliance_checklist.md - Privacy and de-identification verification

🔧 Validation Scripts (8 automation tools)

validate_case_report.py - Check CARE guideline compliance and completeness
check_deidentification.py - Scan for 18 HIPAA identifiers in reports
validate_trial_report.py - Verify ICH-E3 structure and required elements
format_adverse_events.py - Generate AE summary tables from CSV data
generate_report_template.py - Interactive template selection and generation
extract_clinical_data.py - Parse and extract structured clinical data
compliance_checker.py - Verify regulatory compliance requirements
terminology_validator.py - Validate medical terminology and prohibited abbreviations

Quick Start

Generate a Template

cd .claude/skills/clinical-reports/scripts
python generate_report_template.py

# Or specify type directly
python generate_report_template.py --type case_report --output my_case_report.md

Validate a Case Report

python validate_case_report.py my_case_report.md

Check De-identification

python check_deidentification.py my_case_report.md

Validate Clinical Trial Report

python validate_trial_report.py my_csr.md

Key Features

CARE Guidelines Compliance

Complete CARE checklist coverage
De-identification verification
Informed consent documentation
Timeline creation assistance
Literature review integration

Regulatory Compliance

HIPAA - Privacy protection, 18 identifier removal, Safe Harbor method
FDA - 21 CFR Parts 11, 50, 56, 312 compliance
ICH-GCP - Good Clinical Practice standards
ALCOA-CCEA - Data integrity principles

Professional Standards

ACR - American College of Radiology reporting standards
CAP - College of American Pathologists synoptic reporting
CLSI - Clinical Laboratory Standards Institute
CONSORT - Clinical trial reporting
ICH-E3 - Clinical study report structure

Medical Coding Systems

ICD-10-CM - Diagnosis coding
CPT - Procedure coding
SNOMED-CT - Clinical terminology
LOINC - Laboratory observation codes
MedDRA - Medical dictionary for regulatory activities

Common Use Cases

1. Publishing a Clinical Case Report

> Create a clinical case report for a 65-year-old patient with atypical 
  presentation of acute appendicitis

> Check this case report for HIPAA compliance
> Validate against CARE guidelines

2. Writing Diagnostic Reports

> Generate a radiology report template for chest CT
> Create a pathology report for colon resection specimen with adenocarcinoma
> Write a laboratory report for complete blood count

3. Clinical Trial Documentation

> Write a serious adverse event report for hospitalization due to pneumonia
> Create a clinical study report outline for phase 3 diabetes trial
> Generate adverse events summary table from trial data

4. Patient Clinical Notes

> Create a SOAP note for follow-up visit
> Generate an H&P for patient admitted with chest pain
> Write a discharge summary for heart failure hospitalization
> Create a cardiology consultation note

Workflow Examples

Case Report Workflow

Obtain informed consent from patient
Generate template: python generate_report_template.py --type case_report
Write case report following CARE structure
Validate compliance: python validate_case_report.py case_report.md
Check de-identification: python check_deidentification.py case_report.md
Submit to journal with CARE checklist

Clinical Trial SAE Workflow

Generate SAE template: python generate_report_template.py --type sae
Complete SAE form within 24 hours of event
Assess causality using WHO-UMC or Naranjo criteria
Validate completeness: python validate_trial_report.py sae_report.md
Submit to sponsor within regulatory timelines (7 or 15 days)
Notify IRB per institutional policy

Best Practices

Privacy and Ethics

✓ Always obtain informed consent for case reports
✓ Remove all 18 HIPAA identifiers before publication
✓ Use de-identification validation scripts
✓ Document consent in manuscript
✓ Consider re-identification risk for rare conditions

Clinical Quality

✓ Use professional medical terminology
✓ Follow structured reporting templates
✓ Include all required elements
✓ Document chronology clearly
✓ Support diagnoses with evidence

Regulatory Compliance

✓ Meet SAE reporting timelines (7-day, 15-day)
✓ Follow ICH-E3 structure for CSRs
✓ Maintain ALCOA-CCEA data integrity
✓ Document protocol adherence
✓ Use MedDRA coding for adverse events

Documentation Standards

✓ Sign and date all clinical notes
✓ Document medical necessity
✓ Use standard abbreviations only
✓ Avoid prohibited abbreviations (JCAHO "Do Not Use" list)
✓ Maintain legibility and completeness

Integration

The clinical-reports skill integrates seamlessly with:

scientific-writing - For clear, professional medical writing
peer-review - For quality assessment of case reports
citation-management - For literature references in case reports
research-grants - For clinical trial protocol development

Resources

External Standards

CARE Guidelines: https://www.care-statement.org/
ICH-E3 Guideline: https://database.ich.org/sites/default/files/E3_Guideline.pdf
CONSORT Statement: http://www.consort-statement.org/
HIPAA: https://www.hhs.gov/hipaa/
ACR Practice Parameters: https://www.acr.org/Clinical-Resources/Practice-Parameters-and-Technical-Standards
CAP Cancer Protocols: https://www.cap.org/protocols-and-guidelines

Professional Organizations

American Medical Association (AMA)
American College of Radiology (ACR)
College of American Pathologists (CAP)
Clinical Laboratory Standards Institute (CLSI)
International Council for Harmonisation (ICH)

Support

For issues or questions about the clinical-reports skill:

Check the comprehensive reference files
Review templates for examples
Run validation scripts to identify issues
Consult the SKILL.md for detailed guidance

License

Part of the Claude Scientific Writer project. See main LICENSE file.