Write comprehensive clinical reports including case reports (CARE guidelines), diagnostic reports (radiology/pathology/lab), clinical trial reports (ICH-E3, SAE, CSR), and patient documentation (SOAP, H&P, discharge summaries). Full support with templates, regulatory compliance
Installs just this skill. Get the whole plugin for auto-invocation.
⚡ How it fires
How this skill gets triggered: by you, by Claude, or both.
Fires itselfClaude auto-loads it when your prompt matches the work.
You can call itInvoke it directly when you want it.
Slash command/clinical-reports
👁️ Context preview
The summary Claude sees to decide when to auto-load this skill.
Write comprehensive clinical reports including case reports (CARE guidelines), diagnostic reports (radiology/pathology/lab), clinical trial reports (ICH-E3, SAE, CSR), and patient documentation (SOAP, H&P, discharge summaries). Full support with templates, regulatory compliance
📊 Stats
Stars31,545
Forks3,146
LanguagePython
LicenseMIT
📦 Ships with scientific-agent-skills
</> SKILL.md
clinical-reports.SKILL.md
---name: clinical-reports
description: Write comprehensive clinical reports including case reports (CARE guidelines), diagnostic reports (radiology/pathology/lab), clinical trial reports (ICH-E3, SAE, CSR), and patient documentation (SOAP, H&P, discharge summaries). Full support with templates, regulatory compliance (HIPAA, FDA, ICH-GCP), and validation tools.
allowed-tools: Read Write Edit Bash
license: MIT License
required_environment_variables: [{"name": "OPENROUTER_API_KEY", "prompt": "OpenRouter API key for the skill's LLM-powered steps.", "required_for": "optional features"}]
metadata: {"version": "1.2", "skill-author": "K-Dense Inc.", "openclaw": {"primaryEnv": "OPENROUTER_API_KEY", "envVars": [{"name": "OPENROUTER_API_KEY", "required": false, "description": "OpenRouter API key for the skill's LLM-powered steps."}]}}
---# Clinical Report Writing
## Overview
Clinical report writing is the process of documenting medical information with precision, accuracy, and compliance with regulatory standards. This skill covers four major categories of clinical reports: case reports for journal publication, diagnostic reports for clinical practice, clinical trial reports for regulatory submission, and patient documentation for medical records. Apply this skill for healthcare documentation, research dissemination, and regulatory compliance.
**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. All clinical documentation must support evidence-based decision-making and meet professional standards.
- Any complex concept that benefits from visualization
For detailed guidance on creating schematics, refer to the scientific-schematics skill documentation.
---
## Core Capabilities
### 1. Clinical Case Reports for Journal Publication
Clinical case reports describe unusual clinical presentations, novel diagnoses, or rare complications. They contribute to medical knowledge and are published in peer-reviewed journals.
#### CARE Guidelines Compliance
The CARE (CAse REport) guidelines provide a standardized framework for case report writing. All case reports should follow this checklist:
**Title**
- Include the words "case report" or "case study"
- Indicate the area of focus
- Example: "Unusual Presentation of Acute Myocardial Infarction in a Young Patient: A Case Report"
**Keywords**
- 2-5 keywords for indexing and searchability
- Use MeSH (Medical Subject Headings) terms when possible
**Abstract** (structured or unstructured, 150-250 words)
- Introduction: What is unique or novel about the case?
- Patient concerns: Primary symptoms and key medical history
- Diagnoses: Primary and secondary diagnoses
- Interventions: Key treatments and procedures
- Outcomes: Clinical outcome and follow-up
- Conclusions: Main takeaway or clinical lesson
**Introduction**
- Brief background on the medical condition
- Why this case is novel or important
- Literature review of similar cases (brief)
- What makes this case worth reporting
**Patient Information**
- Demographics (age, sex, race/ethnicity if relevant)
- Medical history, family history, social history
- Relevant comorbidities
- **De-identification**: Remove or alter 18 HIPAA identifiers
- **Patient consent**: Document informed consent for publication
**Clinical Findings**
- Chief complaint and presenting symptoms
- Physical examination findings
- Timeline of symptoms (consider timeline figure or table)
- Relevant clinical observations
**Timeline**
- Chronological summary of key events
- Dates of symptoms, diagnosis, interventions, outcomes
- Can be presented as a table or figure
- Example format:
- Day 0: Initial presentation with symptoms X, Y, Z
- Day 2: Diagnostic test A performed, revealed finding B
- Unanswered questions or areas for future research
**Patient Perspective** (optional but encouraged)
- Patient's experience and viewpoint
- Impact on quality of life
- Patient-reported outcomes
- Quote from patient if appropriate
**Informed Consent**
- Statement documenting patient consent for publication
- If patient deceased or unable to consent, describe proxy consent
- For pediatric cases, parental/guardian consent
- Example: "Written informed consent was obtained from the patient for publication of this case report and accompanying images. A copy of the written consent is available for review by the Editor-in-Chief of this journal."
For detailed CARE guidelines, refer to `references/case_report_guidelines.md`.
#### Journal-Specific Requirements
Different journals have specific formatting requirements:
- Word count limits (typically 1500-3000 words)
- Number of figures/tables allowed
- Reference style (AMA, Vancouver, APA)
- Structured vs. unstructured abstract
- Supplementary materials policies
Check journal instructions for authors before submission.
#### De-identification and Privacy
**18 HIPAA Identifiers to Remove or Alter:**
1. Names
2. Geographic subdivisions smaller than state
3. Dates (except year)
4. Telephone numbers
5. Fax numbers
6. Email addresses
7. Social Security numbers
8. Medical record numbers
9. Health plan beneficiary numbers
10. Account numbers
11. Certificate/license numbers
12. Vehicle identifiers and serial numbers
13. Device identifiers and serial numbers
14. Web URLs
15. IP addresses
16. Biometric identifiers
17. Full-face photographs
18. Any other unique identifying characteristic
**Best Practices:**
- Use "the patient" instead of names
- Report age ranges (e.g., "a woman in her 60s") or exact age if relevant
- Use approximate dates or time intervals (e.g., "3 months prior")
- Remove institution names unless necessary
- Blur or crop identifying features in images
- Obtain explicit consent for any potentially identifying information
### 2. Clinical Diagnostic Reports
Diagnostic reports communicate findings from imaging studies, pathological examinations, and laboratory tests. They must be clear, accurate, and actionable.
#### Radiology Reports
Radiology reports follow a standardized structure to ensure clarity and completeness.
**Standard Structure:**
**1. Patient Demographics**
- Patient name (or ID in research contexts)
- Date of birth or age
- Medical record number
- Examination date and time
**2. Clinical Indication**
- Reason for examination
- Relevant clinical history
- Specific clinical question to be answered
- Example: "Rule out pulmonary embolism in patient with acute dyspnea"
- Example: "Contrast-enhanced CT of the chest, abdomen, and pelvis was performed using 100 mL of intravenous iodinated contrast. Oral contrast was not administered."
**4. Comparison**
- Prior imaging studies available for comparison
- Dates of prior studies
- Stability or change from prior imaging
- Example: "Comparison: CT chest from [date]"
**5. Findings**
- Systematic description of imaging findings
- Organ-by-organ or region-by-region approach
- Positive findings first, then pertinent negatives
- Measurements of lesions or abnormalities
- Use of standardized terminology (ACR lexicon, RadLex)
- Example:
- Lungs: Bilateral ground-glass opacities, predominant in the lower lobes. No consolidation or pleural effusion.
- Mediastinum: No lymphadenopathy. Heart size normal.
- Abdomen: Liver, spleen, pancreas unremarkable. No free fluid.
**6. Impression/Conclusion**
- Concise summary of key findings
- Answers to the clinical question
- Differential diagnosis if applicable
- Recommendations for follow-up or additional studies
- Level of suspicion or diagnostic certainty
- Example:
- "1. Bilateral ground-glass opacities consistent with viral pneumonia or atypical infection. COVID-19 cannot be excluded. Clinical correlation recommended.
- 2. No evidence of pulmonary embolism.
- 3. Recommend follow-up imaging in 4-6 weeks to assess resolution."
**Structured Reporting:**
Many radiology departments use structured reporting templates for common examinations:
- Lung nodule reporting (Lung-RADS)
- Breast imaging (BI-RADS)
- Liver imaging (LI-RADS)
- Prostate imaging (PI-RADS)
- CT colonography (C-RADS)
Structured reports improve consistency, reduce ambiguity, and facilitate data extraction.
For radiology reporting standards, see `references/diagnostic_reports_standards.md`.
#### Pathology Reports
Pathology reports document microscopic findings from tissue specimens and provide diagnostic conclusions.
**Surgical Pathology Report Structure:**
**1. Patient Information**
- Patient name and identifiers
- Date of birth, age, sex
- Ordering physician
- Medical record number
- Specimen received date
**2. Specimen Information**
- Specimen type (biopsy, excision, resection)
- Anatomical site
- Laterality if applicable
- Number of specimens/blocks/slides
- Example: "Skin, left forearm, excisional biopsy"
**3. Clinical History**
- Relevant clinical information
- Indication for biopsy
- Prior diagnoses
- Example: "History of melanoma. New pigmented lesion, rule out recurrence."
**4. Gross Description**
- Macroscopic appearance of specimen
- Size, weight, color, consistency
- Orientation markers if present
- Sectioning and sampling approach
- Example: "The specimen consists of an ellipse of skin measuring 2.5 x 1.0 x 0.5 cm. A pigmented lesion measuring 0.6 cm in diameter is present on the surface. The specimen is serially sectioned and entirely submitted in cassettes A1-A3."
**5. Microscopic Description**
- Histological findings
- Cellular characteristics
- Architectural patterns
- Presence of malignancy
- Margins if applicable
- Special stains or immunohistochemistry results
**6. Diagnosis**
- Primary diagnosis
- Grade and stage if applicable (cancer)
- Margin status
- Lymph node status if applicable
- Synoptic reporting for cancers (CAP protocols)
- Example:
- "MALIGNANT MELANOMA, SUPERFICIAL SPREADING TYPE
- Breslow thickness: 1.2 mm
- Clark level: IV
- Mitotic rate: 3/mm²
- Ulceration: Absent
- Margins: Negative (closest margin 0.4 cm)
- Lymphovascular invasion: Not identified"
**7. Comment** (if needed)
- Additional context or interpretation
- Differential diagnosis
- Recommendations for additional studies
- Clinical correlation suggestions
**Synoptic Reporting:**
The College of American Pathologists (CAP) provides synoptic reporting templates for cancer specimens. These checklists ensure all relevant diagnostic elements are documented.
- Examples: glucose <40 or >500 mg/dL, potassium <2.5 or >6.5 mEq/L
- Document notification time and recipient
For laboratory standards and terminology, see `references/diagnostic_reports_standards.md`.
### 3. Clinical Trial Reports
Clinical trial reports document the conduct, results, and safety of clinical research studies. These reports are essential for regulatory submissions and scientific publication.
#### Serious Adverse Event (SAE) Reports
SAE reports document unexpected serious adverse reactions during clinical trials. Regulatory requirements mandate timely reporting to IRBs, sponsors, and regulatory agencies.
**Definition of Serious Adverse Event:**
An adverse event is serious if it:
- Results in death
- Is life-threatening
- Requires inpatient hospitalization or prolongation of existing hospitalization
- Results in persistent or significant disability/incapacity
- Is a congenital anomaly/birth defect
- Requires intervention to prevent permanent impairment or damage
**SAE Report Components:**
**1. Study Information**
- Protocol number and title
- Study phase
- Sponsor name
- Principal investigator
- IND/IDE number (if applicable)
- Clinical trial registry number (NCT number)
**2. Patient Information (De-identified)**
- Subject ID or randomization number
- Age, sex, race/ethnicity
- Study arm or treatment group
- Date of informed consent
- Date of first study intervention
**3. Event Information**
- Event description (narrative)
- Date of onset
- Date of resolution (or ongoing)
- Severity (mild, moderate, severe)
- Seriousness criteria met
- Outcome (recovered, recovering, not recovered, fatal, unknown)
**4. Causality Assessment**
- Relationship to study intervention (unrelated, unlikely, possible, probable, definite)
- Relationship to study procedures
- Relationship to underlying disease
- Rationale for causality determination
**5. Action Taken**
- Modification of study intervention (dose reduction, temporary hold, permanent discontinuation)
- Concomitant medications or treatments administered
- Hospitalization details
- Outcome and follow-up plan
**6. Expectedness**
- Expected per protocol or investigator's brochure
- Unexpected event requiring expedited reporting
- Comparison to known safety profile
**7. Narrative**
- Detailed description of the event
- Timeline of events
- Clinical course and management
- Laboratory and diagnostic test results
- Final diagnosis or conclusion
**8. Reporter Information**
- Name and contact of reporter
- Report date
- Signature
**Regulatory Timelines:**
- Fatal or life-threatening unexpected SAEs: 7 days for preliminary report, 15 days for complete report
- Other serious unexpected events: 15 days
- IRB notification: per institutional policy, typically within 5-10 days
For detailed SAE reporting guidance, see `references/clinical_trial_reporting.md`.
#### Clinical Study Reports (CSR)
Clinical study reports are comprehensive documents summarizing the design, conduct, and results of clinical trials. They are submitted to regulatory agencies as part of drug approval applications.
**ICH-E3 Structure:**
The ICH E3 guideline defines the structure and content of clinical study reports.
**Main Sections:**
**1. Title Page**
- Study title and protocol number
- Sponsor and investigator information
- Report date and version
**2. Synopsis** (5-15 pages)
- Brief summary of entire study
- Objectives, methods, results, conclusions
- Key efficacy and safety findings
- Can stand alone
**3. Table of Contents**
**4. List of Abbreviations and Definitions**
**5. Ethics** (Section 2)
- IRB/IEC approvals
- Informed consent process
- GCP compliance statement
**6. Investigators and Study Administrative Structure** (Section 3)
- List of investigators and sites
- Study organization
- Monitoring and quality assurance
**7. Introduction** (Section 4)
- Background and rationale
- Study objectives and purpose
**8. Study Objectives and Plan** (Section 5)
- Overall design and plan
- Objectives (primary and secondary)
- Endpoints (efficacy and safety)
- Sample size determination
**9. Study Patients** (Section 6)
- Inclusion and exclusion criteria
- Patient disposition
- Protocol deviations
- Demographic and baseline characteristics
**10. Efficacy Evaluation** (Section 7)
- Data sets analyzed (ITT, PP, safety)
- Demographic and other baseline characteristics
- Efficacy results for primary and secondary endpoints
- Subgroup analyses
- Dropouts and missing data
**11. Safety Evaluation** (Section 8)
- Extent of exposure
- Adverse events (summary tables)
- Serious adverse events (narratives)
- Laboratory values
- Vital signs and physical findings
- Deaths and other serious events
**12. Discussion and Overall Conclusions** (Section 9)
- Interpretation of results
- Benefit-risk assessment
- Clinical implications
**13. Tables, Figures, and Graphs** (Section 10)
**14. Reference List** (Section 11)
**15. Appendices** (Section 12)
- Study protocol and amendments
- Sample case report forms
- List of investigators and ethics committees
- Patient information and consent forms
- Investigator's brochure references
- Publications based on the study
**Key Principles:**
- Objectivity and transparency
- Comprehensive data presentation
- Adherence to statistical analysis plan
- Clear presentation of safety data
- Integration of appendices
For ICH-E3 templates and detailed guidance, see `references/clinical_trial_reporting.md` and `assets/clinical_trial_csr_template.md`.
#### Protocol Deviations
Protocol deviations are departures from the approved study protocol. They must be documented, assessed, and reported.
**Categories:**
- **Minor deviation**: Does not significantly impact patient safety or data integrity
- **Major deviation**: May impact patient safety, data integrity, or study conduct
- **Violation**: Serious deviation requiring immediate action and reporting
**Documentation Requirements:**
- Description of deviation
- Date of occurrence
- Subject ID affected
- Impact on safety and data
- Corrective and preventive actions (CAPA)
- Root cause analysis
- Preventive measures implemented
### 4. Patient Clinical Documentation
Patient documentation records clinical encounters, progress, and care plans. Accurate documentation supports continuity of care, billing, and legal protection.
#### SOAP Notes
SOAP notes are the most common format for progress notes in clinical practice.
**Structure:**
**S - Subjective**
- Patient's reported symptoms and concerns
- History of present illness (HPI)
- Review of systems (ROS) relevant to visit
- Patient's own words (use quotes when helpful)
- Example: "Patient reports worsening shortness of breath over the past 3 days, particularly with exertion. Denies chest pain, fever, or cough."
**Final Note**: Clinical report writing requires attention to detail, medical accuracy, regulatory compliance, and clear communication. Whether documenting patient care, reporting research findings, or communicating diagnostic results, the quality of clinical reports directly impacts patient safety, healthcare delivery, and medical knowledge advancement. Always prioritize accuracy, privacy, and professionalism in all clinical documentation.
