Protocol Deviation Classifier

Source: https://github.com/aipoch/medical-research-skills

Protocol Deviation Classifier

Clinical trial protocol deviation classification tool, based on GCP and ICH E6 guidelines, automatically determines whether deviations belong to "major deviations" or "minor deviations".

Quick Check

Use this command to verify that the packaged script entry point can be parsed before deeper execution.

python -m py_compile scripts/main.py

Audit-Ready Commands

Use these concrete commands for validation. They are intentionally self-contained and avoid placeholder paths.

python -m py_compile scripts/main.py
python scripts/main.py --help
python scripts/main.py --input "Audit validation sample with explicit symptoms, history, assessment, and next-step plan." --format json

When to Use

• Use this skill when the task needs Determine whether an incident in a clinical trial is a "major deviation.
• Use this skill for data analysis tasks that require explicit assumptions, bounded scope, and a reproducible output format.
• Use this skill when you need a documented fallback path for missing inputs, execution errors, or partial evidence.

When NOT to Use

• Do not use for classifying adverse events (use a MedDRA coding tool).
• Do not use as the final authority on deviation severity — classification must be confirmed by clinical QA personnel.
• Do not use for non-clinical-trial compliance issues (e.g., manufacturing, lab QC).
• Do not use when the deviation description is too vague to assess impact on safety, data integrity, or scientific validity — request clarification first.

Workflow

1. Receive deviation: Collect the deviation description, type category, and optional severity factors (safety_impact, data_impact, scientific_impact). If the description is vague, request clarification before proceeding.
2. Assess impact dimensions: Evaluate the deviation against three dimensions — Subject Safety (none/low/medium/high), Data Integrity (none/low/medium/high), and Scientific Validity (none/low/medium/high). Use the classification standards tables above as reference.
3. Apply classification rules: Any dimension = High → Major Deviation. Safety = Medium AND (Data OR Science) = Medium+ → Major Deviation. Otherwise → Minor Deviation.
4. Generate output: Return classification with confidence score, rationale, regulatory basis (ICH E6 section references), and recommended actions. Use the JSON output format for batch processing.
5. Fallback: If the deviation type is not in the classification standards table, classify based on the three impact dimensions alone and flag for manual QA review.

Features

• Automatic Classification: Automatically determines severity based on deviation description
• Risk Assessment: Assesses impact on subject safety, data integrity, and scientific validity
• Regulatory Basis: Classification basis complies with GCP, ICH E6, and FDA/EMA guidelines
• Report Generation: Generates deviation classification reports that meet regulatory requirements
• Chinese Support: Full support for Chinese clinical trial scenarios

Deviation Classification Standards

Major/Critical Deviation

Deviations that may affect trial data integrity, subject safety, or trial scientific validity:

Minor Deviation

Deviations unlikely to affect trial data integrity, subject safety, or trial scientific validity:

Usage

Python API

from scripts.main import DeviationClassifier

# Initialize classifier
classifier = DeviationClassifier()

# Classify single deviation
result = classifier.classify(
    description="Subject visit delayed by 2 days",
    deviation_type="Visit Window"
)
print(result.classification)  # "Minor Deviation"
print(result.confidence)      # 0.92
print(result.rationale)       # Classification rationale explanation

# Batch classification
deviations = [
    {"description": "Blood sample collected without informed consent", "type": "Informed Consent"},
    {"description": "Quality of life questionnaire submitted 3 days late", "type": "Data Collection"}
]
batch_results = classifier.classify_batch(deviations)

# Generate report
report = classifier.generate_report(batch_results)

CLI Usage

# Classify single deviation
python scripts/main.py classify --description "Subject visit delayed by 2 days" --type "Visit Window"

# Batch classification from file
python scripts/main.py batch --input deviations.json --output report.json

# Interactive classification
python scripts/main.py interactive

# Assess deviation impact
python scripts/main.py assess \
  --description "Subject accidentally took double dose of investigational drug" \
  --safety-impact high \
  --data-impact medium \
  --scientific-impact medium

Input Format

JSON Input File Format:

[
  {
    "id": "DEV-001",
    "description": "Subject visit delayed by 2 days",
    "type": "Visit Window",
    "occurrence_date": "2024-01-15",
    "severity_factors": {
      "safety_impact": "none",
      "data_impact": "low",
      "scientific_impact": "low"
    }
  },
  {
    "id": "DEV-002",
    "description": "Blood collection performed without informed consent",
    "type": "Informed Consent",
    "severity_factors": {
      "safety_impact": "high",
      "data_impact": "high",
      "scientific_impact": "high"
    }
  }
]

Output Format

Classification Result:

{
  "id": "DEV-001",
  "classification": "Minor Deviation",
  "classification_en": "Minor Deviation",
  "confidence": 0.92,
  "rationale": "Visit time window slightly delayed (2 days), does not affect subject safety, data integrity, or trial scientific validity.",
  "risk_factors": {
    "safety_risk": "none",
    "data_integrity_risk": "low",
    "scientific_validity_risk": "none"
  },
  "regulatory_basis": [
    "ICH E6(R2) Section 4.5",
    "GCP Section 6.4.4"
  ],
  "recommended_actions": [
    "Document in file",
    "Track trends"
  ]
}

Classification Algorithm

Classification based on the following assessment dimensions:

1. Subject Safety Impact (Safety Impact)

   • None: No impact
   • Low: Minor impact
   • Medium: Moderate impact
   • High: Serious impact

2. Data Integrity Impact (Data Integrity Impact)

   • None: No impact
   • Low: Minor impact on non-critical data
   • Medium: Partial impact on critical data
   • High: Serious damage to critical data

3. Trial Scientific Validity Impact (Scientific Validity Impact)

   • None: No impact
   • Low: Minor impact on statistical power
   • Medium: May affect primary endpoint
   • High: Seriously affects trial conclusion

Classification Rules:

• Any dimension is High → Major Deviation
• Safety dimension is Medium and Data/Science either is Medium+ → Major Deviation
• Other cases → Minor Deviation

Regulatory Basis

• ICH E6(R2) Good Clinical Practice Guideline
• ICH E6(R3) Good Clinical Practice Guideline (Draft)
• FDA 21 CFR Part 312 (IND Regulations)
• FDA Guidance for Industry: Oversight of Clinical Investigations
• EMA Reflection Paper on Risk Based Quality Management
• NMPA Good Clinical Practice for Drug Clinical Trials

Dependencies

• Python 3.8+
• No third-party dependencies (pure Python standard library implementation)

Notes

1. This tool provides classification recommendations, final determination must be confirmed by clinical quality assurance personnel
2. Serious/critical deviations must be reported to sponsor and ethics committee immediately
3. It is recommended to regularly review deviation trends and implement CAPA (Corrective and Preventive Actions)
4. Classification standards may vary by regulatory agency, trial type, and protocol requirements