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.

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.

When to Use This Skill

This skill should be used when:

Writing clinical case reports for journal submission (CARE guidelines)
Creating diagnostic reports (radiology, pathology, laboratory)
Documenting clinical trial data and adverse events
Preparing clinical study reports (CSR) for regulatory submission
Writing patient progress notes, SOAP notes, and clinical summaries
Drafting discharge summaries, H&P documents, or consultation notes
Ensuring HIPAA compliance and proper de-identification
Validating clinical documentation for completeness and accuracy
Preparing serious adverse event (SAE) reports
Creating data safety monitoring board (DSMB) reports

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
- Day 5: Treatment initiated with drug C
- Day 14: Clinical improvement noted
- Month 3: Follow-up examination shows complete resolution

Diagnostic Assessment

Diagnostic tests performed (labs, imaging, procedures)
Results and interpretation
Differential diagnosis considered
Rationale for final diagnosis
Challenges in diagnosis

Therapeutic Interventions

Medications (names, dosages, routes, duration)
Procedures or surgeries performed
Non-pharmacological interventions
Reasoning for treatment choices
Alternative treatments considered

Follow-up and Outcomes

Clinical outcome (resolution, improvement, unchanged, worsened)
Follow-up duration and frequency
Long-term outcomes if available
Patient-reported outcomes
Adherence to treatment

Discussion

Strengths and novelty of the case
How this case compares to existing literature
Limitations of the case report
Potential mechanisms or explanations
Clinical implications and lessons learned
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:

Names
Geographic subdivisions smaller than state
Dates (except year)
Telephone numbers
Fax numbers
Email addresses
Social Security numbers
Medical record numbers
Health plan beneficiary numbers
Account numbers
Certificate/license numbers
Vehicle identifiers and serial numbers
Device identifiers and serial numbers
Web URLs
IP addresses
Biometric identifiers
Full-face photographs
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"

3. Technique

Imaging modality (X-ray, CT, MRI, ultrasound, PET, etc.)
Anatomical region examined
Contrast administration (type, route, volume)
Protocol or sequence used
Technical quality and limitations
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.
- 1. No evidence of pulmonary embolism.
- 1. 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.

Key elements for cancer reporting:

Tumor site
Tumor size
Histologic type
Histologic grade
Extent of invasion
Lymph-vascular invasion
Perineural invasion
Margins
Lymph nodes (number examined, number positive)
Pathologic stage (TNM classification)
Ancillary studies (molecular markers, biomarkers)

Laboratory Reports

Laboratory reports communicate test results for clinical specimens (blood, urine, tissue, etc.).

Standard Components:

1. Patient and Specimen Information

Patient identifiers
Specimen type (blood, serum, urine, CSF, etc.)
Collection date and time
Received date and time
Ordering provider

2. Test Name and Method

Full test name
Methodology (immunoassay, spectrophotometry, PCR, etc.)
Laboratory accession number

3. Results

Quantitative or qualitative result
Units of measurement
Reference range (normal values)
Flags for abnormal values (H = high, L = low)
Critical values highlighted
Example:
- Hemoglobin: 8.5 g/dL (L) [Reference: 12.0-16.0 g/dL]
- White Blood Cell Count: 15.2 x10³/μL (H) [Reference: 4.5-11.0 x10³/μL]

4. Interpretation (when applicable)

Clinical significance of results
Suggested follow-up or additional testing
Correlation with diagnosis
Drug levels and therapeutic ranges

5. Quality Control Information

Specimen adequacy
Specimen quality issues (hemolyzed, lipemic, clotted)
Delays in processing
Technical limitations

Critical Value Reporting:

Life-threatening results require immediate notification
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."

O - Objective

Measurable clinical findings
Vital signs (temperature, blood pressure, heart rate, respiratory rate, oxygen saturation)
Physical examination findings (organized by system)
Laboratory and imaging results
Example:
- Vitals: T 98.6°F, BP 142/88, HR 92, RR 22, SpO2 91% on room air
- General: Mild respiratory distress
- Cardiovascular: Regular rhythm, no murmurs
- Pulmonary: Bilateral crackles at bases
- Extremities: 2+ pitting edema bilaterally

A - Assessment

Clinical impression or diagnosis
Differential diagnosis
Severity and stability
Progress toward treatment goals
Example:
- "1. Acute decompensated heart failure, NYHA Class III
- 1. Hypertension, poorly controlled
- 1. Chronic kidney disease, stage 3"

P - Plan

Diagnostic plan (further testing)
Therapeutic plan (medications, procedures)
Patient education and counseling
Follow-up arrangements
Example:
- "Diagnostics: BNP, chest X-ray, echocardiogram
- Therapeutics: Increase furosemide to 40 mg PO BID, continue lisinopril 10 mg daily, strict fluid restriction to 1.5 L/day
- Education: Signs of worsening heart failure, daily weights
- Follow-up: Cardiology appointment in 1 week, call if weight gain >2 lbs in 1 day"

Documentation Tips:

Be concise but complete
Use standard medical abbreviations
Document time of encounter
Sign and date all notes
Avoid speculation or judgment
Document medical necessity for billing
Include patient's response to treatment

For SOAP note templates and examples, see assets/soap_note_template.md.

History and Physical (H&P)

The H&P is a comprehensive assessment performed at admission or initial encounter.

Components:

1. Chief Complaint (CC)

Brief statement of why patient is seeking care
Use patient's own words
Example: "Chest pain for 2 hours"

2. History of Present Illness (HPI)

Detailed chronological narrative of current problem
Use OPQRST mnemonic for pain:
- Onset: When did it start?
- Provocation/Palliation: What makes it better or worse?
- Quality: What does it feel like?
- Region/Radiation: Where is it? Does it spread?
- Severity: How bad is it (0-10 scale)?
- Timing: Constant or intermittent? Duration?
Associated symptoms
Prior evaluations or treatments

3. Past Medical History (PMH)

Chronic medical conditions
Previous hospitalizations
Surgeries and procedures
Example: "Hypertension (diagnosed 2015), type 2 diabetes mellitus (diagnosed 2018), prior appendectomy (2010)"

4. Medications

Current medications with doses and frequencies
Over-the-counter medications
Herbal supplements
Allergies and reactions

5. Allergies

Drug allergies with type of reaction
Food allergies
Environmental allergies
Example: "Penicillin (rash), shellfish (anaphylaxis)"

6. Family History (FH)

Medical conditions in first-degree relatives
Age and cause of death of parents
Hereditary conditions
Example: "Father with coronary artery disease (MI at age 55), mother with breast cancer (diagnosed age 62)"

7. Social History (SH)

Tobacco use (pack-years)
Alcohol use (drinks per week)
Illicit drug use
Occupation
Living situation
Sexual history if relevant
Example: "Former smoker, quit 5 years ago (20 pack-year history). Occasional alcohol (2-3 drinks/week). Works as accountant. Lives with spouse."

8. Review of Systems (ROS)

Systematic review of symptoms by organ system
Typically 10-14 systems
Pertinent positives and negatives
Systems: Constitutional, Eyes, ENT, Cardiovascular, Respiratory, GI, GU, Musculoskeletal, Skin, Neurological, Psychiatric, Endocrine, Hematologic/Lymphatic, Allergic/Immunologic

9. Physical Examination

Vital signs
General appearance
Systematic examination by organ system
HEENT, Neck, Cardiovascular, Pulmonary, Abdomen, Extremities, Neurological, Skin
Use standard terminology and abbreviations

10. Assessment and Plan

Problem list with assessment and plan for each
Numbered list format
Diagnostic and therapeutic plans
Disposition (admit, discharge, transfer)

For H&P templates, see assets/history_physical_template.md.

Discharge Summaries

Discharge summaries document the hospital stay and communicate care plan to outpatient providers.

Required Elements:

1. Patient Identification

Name, date of birth, medical record number
Admission and discharge dates
Attending physician
Admitting and discharge diagnoses

2. Reason for Hospitalization

Brief description of presenting problem
Chief complaint

3. Hospital Course

Chronological narrative of key events
Significant findings and procedures
Response to treatment
Complications
Consultations obtained
Organized by problem or chronologically

4. Discharge Diagnoses

Primary diagnosis
Secondary diagnoses
Complications
Comorbidities

5. Procedures Performed

Surgeries
Invasive procedures
Diagnostic procedures

6. Discharge Medications

Complete medication list with instructions
Changes from admission medications
New medications with indications

7. Discharge Condition

Stable, improved, unchanged, expired
Functional status
Mental status

8. Discharge Disposition

Home, skilled nursing facility, rehabilitation, hospice
With or without services

9. Follow-up Plans

Appointments scheduled
Recommended follow-up timing
Pending tests or studies
Referrals

10. Patient Instructions

Activity restrictions
Dietary restrictions
Wound care
Warning signs to seek care
Medication instructions

Best Practices:

Complete within 24-48 hours of discharge
Use clear language for outpatient providers
Highlight important pending results
Document code status discussions
Include patient education provided

For discharge summary templates, see assets/discharge_summary_template.md.

Regulatory Compliance and Privacy

HIPAA Compliance

The Health Insurance Portability and Accountability Act (HIPAA) mandates protection of patient health information.

Key Requirements:

Minimum necessary disclosure
Patient authorization for use beyond treatment/payment/operations
Secure storage and transmission
Audit trails for electronic records
Breach notification procedures

De-identification Methods:

Safe Harbor Method: Remove 18 identifiers
Expert Determination: Statistical method confirming low re-identification risk

Business Associate Agreements: Required when PHI is shared with third parties for services

For detailed HIPAA guidance, see references/regulatory_compliance.md.

FDA Regulations

Clinical trial documentation must comply with FDA regulations:

21 CFR Part 11 (Electronic Records and Signatures)
21 CFR Part 50 (Informed Consent)
21 CFR Part 56 (IRB Standards)
21 CFR Part 312 (IND Regulations)

ICH-GCP Guidelines

Good Clinical Practice (GCP) guidelines ensure quality and ethical standards in clinical trials:

Protocol adherence
Informed consent documentation
Source document requirements
Audit trails and data integrity
Investigator responsibilities

For ICH-GCP compliance, see references/regulatory_compliance.md.

Medical Terminology and Standards

Standardized Nomenclature

SNOMED CT (Systematized Nomenclature of Medicine - Clinical Terms)

Comprehensive clinical terminology
Used for electronic health records
Enables semantic interoperability

LOINC (Logical Observation Identifiers Names and Codes)

Standard for laboratory and clinical observations
Facilitates data exchange and reporting

ICD-10-CM (International Classification of Diseases, 10th Revision, Clinical Modification)

Diagnosis coding for billing and epidemiology
Required for reimbursement

CPT (Current Procedural Terminology)

Procedure coding for billing
Maintained by AMA

Abbreviation Standards

Acceptable Abbreviations: Use standard abbreviations to improve efficiency while maintaining clarity.

Do Not Use List (Joint Commission):

U (unit) - write "unit"
IU (international unit) - write "international unit"
QD, QOD (daily, every other day) - write "daily" or "every other day"
Trailing zero (X.0 mg) - never use after decimal
Lack of leading zero (.X mg) - always use before decimal (0.X mg)
MS, MSO4, MgSO4 - write "morphine sulfate" or "magnesium sulfate"

For comprehensive terminology standards, see references/medical_terminology.md.

Quality Assurance and Validation

Documentation Quality Principles

Completeness:

All required elements present
No missing data fields
Comprehensive patient information

Accuracy:

Factually correct information
Verified data sources
Appropriate clinical reasoning

Timeliness:

Documented contemporaneously or shortly after encounter
Time-sensitive reports prioritized
Regulatory deadlines met

Clarity:

Clear and unambiguous language
Organized logical structure
Appropriate use of medical terminology

Compliance:

Regulatory requirements met
Privacy protections in place
Institutional policies followed

Validation Checklists

For each report type, use validation checklists to ensure quality:

Case report CARE checklist
Diagnostic report completeness
SAE report regulatory compliance
Clinical documentation billing requirements

Validation scripts are available in the scripts/ directory.

Data Presentation in Clinical Reports

Tables and Figures

Tables for Clinical Data:

Demographic and baseline characteristics
Adverse events summary
Laboratory values over time
Efficacy outcomes

Table Design Principles:

Clear column headers with units
Footnotes for abbreviations and statistical notes
Consistent formatting
Appropriate precision (significant figures)

Figures for Clinical Data:

Kaplan-Meier survival curves
Forest plots for subgroup analyses
Patient flow diagrams (CONSORT)
Timeline figures for case reports
Before-and-after images

Image Guidelines:

High resolution (300 dpi minimum)
Appropriate scale bars
Annotations for key features
De-identified (no patient identifiers visible)
Informed consent for recognizable images

For data presentation standards, see references/data_presentation.md.

Integration with Other Skills

This clinical reports skill integrates 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
Literature Review: For background sections in case reports

Workflow for Clinical Report Writing

Case Report Workflow

Phase 1: Case Identification and Consent (Week 1)

Identify novel or educational case
Obtain patient informed consent
De-identify patient information
Collect clinical data and images

Phase 2: Literature Review (Week 1-2)

Search for similar cases
Review relevant pathophysiology
Identify knowledge gaps
Determine novelty and significance

Phase 3: Drafting (Week 2-3)

Write structured outline following CARE guidelines
Draft all sections (abstract through discussion)
Create timeline and figures
Format references

Phase 4: Internal Review (Week 3-4)

Co-author review
Attending physician review
Institutional review if required
Patient review of de-identified draft

Phase 5: Journal Selection and Submission (Week 4-5)

Select appropriate journal
Format per journal guidelines
Prepare cover letter
Submit manuscript

Phase 6: Revision (Variable)

Respond to peer reviewer comments
Revise manuscript
Resubmit

Diagnostic Report Workflow

Real-time Workflow:

Review clinical indication and prior studies
Interpret imaging, pathology, or laboratory findings
Dictate or type report using structured format
Peer review for complex cases
Final sign-out and distribution
Critical value notification if applicable

Turnaround Time Benchmarks:

STAT reports: <1 hour
Routine reports: 24-48 hours
Complex cases: 2-5 days
Pending additional studies: documented delay

Clinical Trial Report Workflow

SAE Report: 24 hours to 15 days

Event identified by site
Initial assessment and documentation
Causality and expectedness determination
Report completion and review
Submission to sponsor, IRB, FDA (as required)
Follow-up reporting until resolution

CSR: 6-12 months post-study completion

Database lock and data cleaning
Statistical analysis per SAP
Drafting by medical writer
Review by biostatistician and clinical team
Quality control review
Final approval and regulatory submission

Resources

This skill includes comprehensive reference files and templates:

Reference Files

references/case_report_guidelines.md - CARE guidelines, journal requirements, writing tips
references/diagnostic_reports_standards.md - ACR, CAP, laboratory reporting standards
references/clinical_trial_reporting.md - ICH-E3, CONSORT, SAE reporting, CSR structure
references/patient_documentation.md - SOAP notes, H&P, discharge summaries, coding
references/regulatory_compliance.md - HIPAA, 21 CFR Part 11, ICH-GCP, FDA requirements
references/medical_terminology.md - SNOMED, LOINC, ICD-10, abbreviations, nomenclature
references/data_presentation.md - Tables, figures, safety data, CONSORT diagrams
references/peer_review_standards.md - Review criteria for clinical manuscripts

Template Assets

assets/case_report_template.md - Structured case report following CARE guidelines
assets/radiology_report_template.md - Standard radiology report format
assets/pathology_report_template.md - Surgical pathology report with synoptic elements
assets/lab_report_template.md - Clinical laboratory report format
assets/clinical_trial_sae_template.md - Serious adverse event report form
assets/clinical_trial_csr_template.md - Clinical study report outline per ICH-E3
assets/soap_note_template.md - SOAP progress note format
assets/history_physical_template.md - Comprehensive H&P template
assets/discharge_summary_template.md - Hospital discharge summary
assets/consult_note_template.md - Consultation note format
assets/quality_checklist.md - Quality assurance checklist for all report types
assets/hipaa_compliance_checklist.md - Privacy and de-identification checklist

Automation Scripts

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

Load these resources as needed when working on specific clinical reports.

Common Pitfalls to Avoid

Case Reports

Privacy violations: Inadequate de-identification or missing consent
Lack of novelty: Reporting common or well-documented cases
Insufficient detail: Missing key clinical information
Poor literature review: Failure to contextualize within existing knowledge
Overgeneralization: Drawing broad conclusions from single case

Diagnostic Reports

Vague language: Using ambiguous terms like "unremarkable" without specifics
Incomplete comparison: Not reviewing prior imaging
Missing clinical correlation: Failing to answer clinical question
Technical jargon: Overuse of terminology without explanation
Delayed critical value notification: Not communicating urgent findings

Clinical Trial Reports

Late reporting: Missing regulatory deadlines for SAE reporting
Incomplete causality: Inadequate causality assessment
Data inconsistencies: Discrepancies between data sources
Protocol deviations: Unreported or inadequately documented deviations
Selective reporting: Omitting negative or unfavorable results

Patient Documentation

Illegibility: Poor handwriting in paper records
Copy-forward errors: Propagating outdated information
Insufficient detail: Vague or incomplete documentation affecting billing
Lack of medical necessity: Not documenting indication for services
Missing signatures: Unsigned or undated notes

Final Checklist

Before finalizing any clinical report, verify:

All required sections complete
Patient privacy protected (HIPAA compliance)
Informed consent obtained (if applicable)
Accurate and verified clinical data
Appropriate medical terminology and coding
Clear, professional language
Proper formatting per guidelines
References cited appropriately
Figures and tables labeled correctly
Spell-checked and proofread
Regulatory requirements met
Institutional policies followed
Signatures and dates present
Quality assurance review completed

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.

Install Skill

SKILL.md