What problem does it solve? Writing clinical documentation that meets CARE guidelines, ICH-E3 structure, HIPAA de-identification rules, and FDA/ICH-GCP regulatory requirements is time-consuming and error-prone. This Skill provides structured templates, reference standards, and automated validation scripts to produce compliant clinical reports. ## Core Features & Use Cases - Four Report Categories: Clinical case reports (CARE guidelines), diagnostic reports (radiology ACR, pathology CAP, laboratory CLSI), clinical trial reports (SAE, ICH-E3 CSR, CONSORT), and patient documentation (SOAP notes, H&P, discharge summaries, consult notes). - 12 Professional Templates: Ready-to-use Markdown templates for case reports, SOAP notes, radiology/pathology/lab reports, SAE forms, and HIPAA compliance checklists. - 8 Validation Scripts: Python tools to check CARE compliance, scan for 18 HIPAA identifiers, validate ICH-E3 structure, format adverse event tables, and flag prohibited abbreviations. - Use Case: A physician needs to publish a case report on an atypical appendicitis presentation. Generate the CARE-compliant template, draft the report, then run validate_case_report.py and check_deidentification.py to confirm guideline compliance and privacy protection before journal submission. ## Quick Start Ask the AI to create a CARE-compliant clinical case report for a patient with an unusual presentation, then validate it for HIPAA de-identification.
