clinical-reports

The Clinical Reports skill provides an end-to-end framework for medical professionals and clinical researchers to generate high-quality, compliant documentation. It covers a broad spectrum of medical writing needs, ranging from peer-reviewed journal case reports following CARE guidelines to complex regulatory submissions such as Clinical Study Reports (CSR) under ICH-E3 standards. By integrating templates for SOAP notes, History & Physical (H&P) documents, and discharge summaries, the skill ensures consistency and professional standards across all patient care workflows.

• Support for diverse documentation formats including pathology (CAP), radiology (ACR), and laboratory (CLSI) diagnostic reports.

• Regulatory compliance automation covering HIPAA de-identification protocols, FDA submission requirements, and ICH-GCP guidelines for clinical trials.

• Mandatory integration of scientific schematics via the scientific-schematics skill to enhance reports with clinical timelines, CONSORT flow diagrams, and treatment algorithm visualizations.

• Comprehensive validation tools to check for completeness, accuracy, and adherence to medical terminology standards like SNOMED-CT, LOINC, and ICD-10.

• Structured template-driven workflows for Serious Adverse Event (SAE) reporting and Data Safety Monitoring Board (DSMB) communication.

• Users should input raw clinical findings, patient histories, or trial data; the skill outputs finalized, formatted reports ready for review or submission.

• Ensure all patient data is appropriately de-identified before processing to maintain HIPAA compliance; the skill provides guidance on removing the 18 specific HIPAA identifiers.

• Utilize the automatic schematic generation feature for every report to meet mandatory visualization requirements; describe the desired flow or timeline in natural language.

• The tool is intended for use by clinicians, research coordinators, and medical writers; it is not a substitute for professional medical judgment.

• Constraints include strict adherence to the provided templates and regulatory checklists to maintain the integrity of clinical study reports and medical records.