ICSR Management

Overview

The ICSR (Individual Case Safety Report) module is the core of VIGIA’s pharmacovigilance platform, enabling complete management of adverse event reports from initial intake through regulatory submission.

Full Lifecycle Tracking

Track cases from intake → evaluation → submission → follow-up

Duplicate Detection

AI-powered duplicate detection with configurable matching algorithms

Multi-Product Support

Manage suspect products, concomitant medications, and product details

Regulatory Export

Generate DIGEMID-compliant reports and E2B XML exports

Key Features

Case Creation and Data Entry

Create comprehensive case reports with structured data collection:

Patient Information

Record patient demographics, initials (anonymized), age, sex, weight, and medical history

# API: POST /api/v1/icsr
{
  "paciente_iniciales": "ABC",
  "paciente_edad": 45,
  "paciente_sexo": "Femenino",
  "paciente_peso": 68.5,
  "paciente_diagnostico_principal": "Hipertensión"
}

Product Details

Add suspect products and concomitant medications with complete pharmaceutical data

Product name, active ingredient (IFA), pharmaceutical form
Registration number, batch number, administration route
Dosage, frequency, start/end dates
Re-challenge and de-challenge information

Adverse Event Description

Document the adverse event with narrative description, dates, severity, and outcome

Reporter Information

Capture reporter details including contact information, occupation, and notification source

ICSR Workflow States

Cases progress through defined workflow states:

Estado	Description	Actions Available
Pendiente	Initial intake, awaiting review	Edit, Assign
En progreso	Under evaluation	Add follow-up, Request info
Completado	Evaluation complete	Export, Submit
Enviado	Submitted to regulatory authority	Track submission

Duplicate Detection

VIGIA uses advanced algorithms to detect potential duplicate cases:

# API: GET /api/v1/icsr/{icsr_id}/duplicates?days_window=60

Matching Criteria:

Patient initials + Date of birth + Event start date + Product (90% match)
Individual criteria weighted:
- Same initials: +20%
- Same date of birth: +25%
- Same event start date: +20%
- Same suspect product: +20%
- Narrative similarity (NLP): up to +25%

Duplicate Status Classification:

Score ≥ 80%: Duplicate (red flag)
Score 45-79%: Review required (yellow flag)
Score < 45%: Unique (green)

Users can manually override duplicate detection decisions. All overrides are audited.

Product Registry Integration

Automatic enrichment from product catalog:

# When a registration number is entered, VIGIA automatically fetches:
# - Laboratory/manufacturer
# - Registration expiration date
# - Pharmaceutical form details

# Source: backend/app/routers/icsr.py:271-302
product_data = get_product_by_rs(db, registration_number)

Multi-Event Support

Each ICSR can track multiple adverse events with individual MedDRA coding:

# API: PUT /api/v1/icsr/{icsr_id}/eventos
{
  "eventos": [
    {
      "texto": "Náuseas severas",
      "fecha_inicio": "2024-01-15",
      "gravedad": "Grave",
      "causalidad": "Posible",
      "meddra_pt_code": "10028813",
      "meddra_pt_term": "Nausea"
    },
    {
      "texto": "Vómitos persistentes",
      "fecha_inicio": "2024-01-16",
      "gravedad": "Moderada",
      "causalidad": "Probable"
    }
  ]
}

When updating eventos, the entire array is replaced. Include all events in your update payload.

API Endpoints

List and Search

GET /api/v1/icsr?page=1&page_size=20&q=search_term&fecha_desde=2024-01-01&fecha_hasta=2024-12-31

Query Parameters:

q: Search across patient initials, products, reporter name
fecha_desde / fecha_hasta: Filter by event start date
order_by: Sort field (default: id)
order_dir: asc or desc

Response:

{
  "items": [...],
  "total": 145,
  "page": 1,
  "page_size": 20
}

Get Single ICSR

GET /api/v1/icsr/{icsr_id}

Returns complete case data with:

All related products (suspect + concomitant)
All follow-up records
All adverse events with MedDRA coding
Product catalog enrichment data

Create ICSR

POST /api/v1/icsr
Content-Type: application/json

{
  "paciente_iniciales": "JDR",
  "paciente_edad": 52,
  "paciente_sexo": "Masculino",
  "producto_sospechoso": "Paracetamol 500mg",
  "fecha_inicio_evento": "2024-03-01",
  "descripcion_evento": "Paciente presenta erupción cutánea...",
  "gravedad": "Moderada",
  "reportante_nombre": "Dr. Juan Pérez",
  "reportante_ocupacion": "Médico",
  "productos": [
    {
      "nombre_producto": "Paracetamol",
      "ifa": "Paracetamol",
      "dosis_frecuencia": "500mg cada 8h",
      "fecha_inicio": "2024-02-28"
    }
  ]
}

Auto-notifications: When a new ICSR is created, VIGIA automatically sends email notifications to configured stakeholders (Pharmacovigilance team, QA, etc.) based on environment variables:

ICSR_NOTIFY_CARGOS: Job positions to notify
ICSR_NOTIFY_AREAS: Departments to notify
ICSR_NOTIFY_EMAILS: Additional email addresses

Update ICSR

PUT /api/v1/icsr/{icsr_id}

Updates only the fields provided (partial update). Related arrays (productos, concomitantes, seguimientos) are only replaced if explicitly included in the payload.

PUT /api/v1/icsr/{icsr_id}/full

Full replacement mode - always replaces related arrays even if provided.

Export to PDF

GET /api/v1/icsr/{icsr_id}/export/digemid-pdf

Generates a DIGEMID-compliant causality report PDF using the template system. Template location: backend/app/templates/docs/INFORME_CAUSALIDAD.docx

Delete ICSR (Secure)

DELETE /api/v1/icsr/{icsr_id}
Content-Type: application/json

{
  "password": "user_password"
}

Security requirement: Deletion requires the current user’s password for confirmation. This prevents accidental deletions.

Before deletion, check dependencies:

GET /api/v1/icsr/{icsr_id}/delete-summary

Returns counts of:

Follow-up messages
Detail snapshots
Related records

Follow-up Management

Automatic follow-up for missing information:

# System automatically:
# 1. Detects missing required fields
# 2. Extracts reporter email from contact info
# 3. Sends follow-up request
# 4. Logs outgoing message
# 5. Updates case state to "En progreso"

# Source: backend/app/routers/icsr.py:305-358

Missing fields detection:

Patient: Date of birth, diagnostic, outcome
Product: Batch number, dates, re-challenge info
Event: Detailed narrative, lab results

Code References

Feature	Implementation
ICSR Model	`backend/app/models/icsr.py:14-254`
Router (CRUD)	`backend/app/routers/icsr.py:629-1073`
Duplicate Detection	`backend/app/routers/icsr.py:389-480`
Product Enrichment	`backend/app/routers/icsr.py:271-302`
Auto Follow-up	`backend/app/routers/icsr.py:305-358`
Notifications	`backend/app/routers/icsr.py:213-270`

Best Practices

Data Quality

Always provide patient initials (anonymized)
Use standardized product names
Include registration numbers when available
Document narrative in detail

Workflow Management

Review duplicate alerts before saving
Complete causality assessment promptly
Use follow-up system for missing data
Export to PDF before submission

Adverse Event Reporting - MedDRA coding and causality assessment
Document Management - Attach supporting documents
Surveillance - Monitor for signals across cases

Get Started

Core Features

User Guides

Modules

Regulatory

Administration

ICSR Management

Overview

Full Lifecycle Tracking

Duplicate Detection

Multi-Product Support

Regulatory Export

Key Features

Case Creation and Data Entry

ICSR Workflow States

Duplicate Detection

Product Registry Integration

Multi-Event Support

API Endpoints

List and Search

Get Single ICSR

Create ICSR

Update ICSR

Export to PDF

Delete ICSR (Secure)

Follow-up Management

Code References

Best Practices

Data Quality

Workflow Management

Build docs developers (and LLMs) love

Get Started

Core Features

User Guides

Modules

Regulatory

Administration

​Overview

Full Lifecycle Tracking

Duplicate Detection

Multi-Product Support

Regulatory Export

​Key Features

​Case Creation and Data Entry

​ICSR Workflow States

​Duplicate Detection

​Product Registry Integration

​Multi-Event Support

​API Endpoints

​List and Search

​Get Single ICSR

​Create ICSR

​Update ICSR

​Export to PDF

​Delete ICSR (Secure)

​Follow-up Management

​Code References

​Best Practices

Data Quality

Workflow Management

​Related Features

Build docs developers (and LLMs) love

Overview

Key Features

Case Creation and Data Entry

ICSR Workflow States

Duplicate Detection

Product Registry Integration

Multi-Event Support

API Endpoints

List and Search

Get Single ICSR

Create ICSR

Update ICSR

Export to PDF

Delete ICSR (Secure)

Follow-up Management

Code References

Best Practices

Related Features