Writes comprehensive clinical reports — case reports (CARE guidelines), diagnostic reports (radiology, pathology, lab), clinical trial reports (ICH-E3, SAE, CSR), and patient documentation (SOAP notes, H&P, discharge summaries) — with templates, regulatory compliance (HIPAA, FDA, ICH-GCP), and validation tools. Use when drafting a case report for journal publication, a radiology/pathology/lab diagnostic report, an ICH-E3 clinical study report (CSR) or SAE narrative, or SOAP/H&P/discharge patient records needing regulatory-compliant formatting. Part of the AlterLab Academic Skills suite.
Writes comprehensive clinical reports — case reports (CARE guidelines), diagnostic reports (radiology, pathology, lab), clinical trial reports (ICH-E3, SAE, CSR), and patient documentation (SOAP notes, H&P, discharge summaries) — with templates, regulatory compliance (HIPAA, FDA, ICH-GCP), and validation tools. Use when drafting a case report for journal publication, a radiology/pathology/lab diagnostic report, an ICH-E3 clinical study report (CSR) or SAE narrative, or SOAP/H&P/discharge patient records needing regulatory-compliant formatting. Part of the AlterLab Academic Skills suite.
allowed-tools
Read Write Edit Bash
license
MIT
compatibility
Runs with Read/Write/Edit/Bash; producing PDF/report output requires a local LaTeX toolchain. No API key required.
metadata
{"skill-author":"AlterLab","version":"1.0.0"}
Clinical Report Writing
Overview
Document medical information with precision, accuracy, and regulatory compliance.
This skill covers four report families: case reports for journal publication,
for clinical practice (radiology, pathology, lab),
for regulatory submission (SAE, CSR), and for medical records (SOAP, H&P, discharge).
diagnostic reports
clinical trial reports
patient
documentation
Critical principle: clinical reports must be accurate, complete, objective, and
compliant with applicable regulations (HIPAA, FDA, ICH-GCP). Patient privacy and
data integrity are paramount.
When to Use This Skill
Use when:
Writing a clinical case report for journal submission (CARE guidelines)
Creating a diagnostic report (radiology, pathology, laboratory)
Documenting clinical trial data, SAE narratives, or a CSR (ICH-E3)
Writing SOAP notes, H&P, discharge summaries, or consult notes
Ensuring HIPAA compliance and proper de-identification
Validating clinical documentation for completeness and accuracy
Core Workflow
Pick the report family and load its detailed reference (see index below).
Draft from the template in assets/ for that report type.
Each uses a standardized section structure (demographics → indication → technique →
comparison → findings → impression for radiology; gross/microscopic/diagnosis for
pathology; results with reference ranges and critical-value reporting for lab).
Use structured-reporting templates (BI-RADS, Lung-RADS, CAP synoptic) where they apply.
→ Full section templates: references/diagnostic_report_templates.md.
Standards and lexicons (ACR, CAP, LOINC): references/diagnostic_reports_standards.md.
3. Clinical trial reports (SAE, CSR, deviations)
SAE reports document serious adverse events with causality and expectedness, on
strict regulatory timelines (7/15 days). CSRs follow the ICH-E3 section structure
for regulatory submission. Protocol deviations are categorized (minor/major/violation)
with CAPA documentation.
→ Component-by-component structures: references/clinical_trial_report_structures.md.
Regulatory framing (ICH-E3, CONSORT, timelines): references/clinical_trial_reporting.md.
4. Patient documentation (SOAP, H&P, discharge)
SOAP notes for progress, H&P for admission/initial encounters, discharge summaries
for handoff to outpatient providers. Use standard abbreviations, sign and date,
document medical necessity for billing.
→ Format structures: references/patient_record_formats.md.
Coding and documentation guidance: references/patient_documentation.md.
Regulatory Compliance and Privacy
HIPAA: minimum-necessary disclosure; de-identify via Safe Harbor (remove 18
identifiers) or Expert Determination; Business Associate Agreements for third parties.
FDA: 21 CFR Part 11 (e-records/signatures), Part 50 (consent), Part 56 (IRB),
Part 312 (IND).
⚠️ Caveat — automated de-identification is NOT a compliance guarantee. The bundled scripts/check_deidentification.py is a pure regex scan. Pattern matching has known, substantial false-negative rates: it misses unconventional name spellings, free-text dates, narrative addresses, rare identifiers, and anything outside its fixed patterns. It is a rough first-pass screen only — not a substitute for line-by-line manual review by a qualified person, and not a validated de-identification tool (e.g., Microsoft Presidio, Philter, or a certified Expert Determination). Passing this script does not establish HIPAA Safe Harbor compliance and must never be relied upon as a privacy guarantee. Always perform manual review before any disclosure or publication.
Use standardized nomenclature: SNOMED CT (clinical terms), LOINC (lab/clinical
observations), ICD-10-CM (diagnosis coding), CPT (procedure coding). Respect the
Joint Commission "Do Not Use" abbreviation list (e.g. write "unit" not "U", always use a
leading zero, never a trailing zero).
Comprehensive standards: references/medical_terminology.md.
Data Presentation
Tables for demographics, adverse events, lab values over time, and efficacy outcomes;
figures for Kaplan-Meier curves, forest plots, CONSORT flow diagrams, and case-report
timelines. Images must be ≥300 dpi, de-identified, with consent for recognizable
patients. Detail: references/data_presentation.md.
Quality Assurance
Documentation must be complete, accurate, timely, clear, and compliant. Use the
per-type validation checklists (CARE, diagnostic completeness, SAE regulatory
compliance, billing requirements) and the scripts/ validators.
Workflows by Report Type
Case report: identify case + consent → literature review → draft (CARE) → internal
review → journal selection/submission → revision.
Final note: clinical report quality directly impacts patient safety, healthcare
delivery, and medical knowledge. Always prioritize accuracy, privacy, and professionalism.
