Generating Reports

VIGIA generates regulatory-compliant reports for health authorities and internal safety monitoring. This guide covers IPS/PSUR (Periodic Safety Update Reports), DIGEMID exports, and custom document generation.

Overview

VIGIA supports:

IPS/PSUR Reports: ICH E2C(R2) compliant periodic safety reports
DIGEMID Exports: Peru regulatory authority format (Modelo B, RAM forms)
Signal Detection: Aggregate analysis and trend identification
Document Templates: Customizable DOCX/PDF generation
Calendar Management: Automated report scheduling by product

IPS/PSUR Report Generation

Overview

IPS (Informe Periódico de Seguridad) / PSUR (Periodic Safety Update Report) summarizes the safety profile of a product over a defined period. Structure (ICH E2C R2):

Executive Summary
Product Information
Data Sources
Cumulative Summary of Safety Data
Benefit-Risk Analysis
Signal Evaluation
Literature Search Results
Conclusion

Workflow

Access IPS Calendar

Navigate to Reports > IPS CalendarURL: /calendario-ipsView scheduled IPS reports by product:

Product	Period	Due Date	Status
Paracetamol 500mg	Q1 2024 (Jan-Mar)	2024-04-15	Draft
Ibuprofeno 400mg	6M 2023-2 (Jul-Dec)	2024-01-31	Submitted
Omeprazol 20mg	Annual 2023	2024-02-28	In Progress

Create New IPS

Click + New IPS > Select product and period:

Product: [Paracetamol 500mg ▼]
Period Type: [Quarterly ▼]
Period: Q2 2024 (Apr-Jun)
Data Lock Point: [2024-06-30 ▼]
Submission Deadline: [2024-07-31 ▼]

API:

POST /api/v1/ips
Body: {
  "producto_id": 123,
  "periodo_tipo": "quarterly",
  "periodo_inicio": "2024-04-01",
  "periodo_fin": "2024-06-30",
  "fecha_corte": "2024-06-30",
  "fecha_limite": "2024-07-31"
}

Configure Data Sources

Select which data sources to include:

Internal Cases (VIGIA database)

Literature (PubMed, LILACS, SciELO)

Regulatory Databases (DIGEMID, FDA FAERS, EMA EudraVigilance)

Clinical Trials (if applicable)

Configure search parameters:

{
  "sources": {
    "vigia": {"enabled": true, "product_id": 123},
    "pubmed": {
      "enabled": true,
      "query": "paracetamol AND (adverse OR toxicity)",
      "date_range": "2024-04-01 to 2024-06-30"
    },
    "digemid": {"enabled": true, "product_name": "Paracetamol"}
  }
}

Run Data Collection

Click Collect Data. The system:

Internal Cases:
```
GET /api/v1/icsr?producto_id=123&
    fecha_recepcion_min=2024-04-01&
    fecha_recepcion_max=2024-06-30
```
Groups cases by:
- Severity (grave/no grave)
- Outcome (recovered, ongoing, death)
- MedDRA SOC (System Organ Class)

Literature Search:

# backend/app/services/biblio_sources.py

search_pubmed(query, date_range) → [
  {"title": "...", "pmid": 12345, "abstract": "..."},
  ...
]

search_lilacs(query, date_range) → [...]

AI screening for safety signals:

for article in results:
    article["safety_hit"] = contains_safety_signal(article.abstract)

Regulatory Database Queries:
- DIGEMID: search_digemid_nordic(product, period)
- FDA FAERS: search_fda(product, period)
- EMA: search_ema(product, period)

Results displayed in Data Summary panel:

✓ Internal Cases: 45 (23 grave, 22 no grave)
✓ PubMed: 128 articles (12 safety-relevant)
✓ LILACS: 34 articles (3 safety-relevant)
✓ DIGEMID: 8 cases
✓ FDA FAERS: 234 cases

Aggregate Analysis

Navigate to Analysis tab. The system auto-calculates:Cumulative Exposure:

Period: 12,450 patients
Cumulative (since launch): 3,245,890 patients

Incidence Rates:

Hepatotoxicity: 0.18 per 10,000 patient-years
Rash: 1.24 per 10,000 patient-years
Anaphylaxis: 0.02 per 10,000 patient-years

Case Distribution by SOC:

SOC	Count	%
Gastrointestinal disorders	18	40%
Skin and subcutaneous tissue disorders	12	27%
Hepatobiliary disorders	8	18%
General disorders	7	15%

Signal Detection:

Disproportionality analysis (PRR, ROR)
Emerging patterns
Serious unlisted events

Generate Document

Click Generate Report > Select format:

Format: [DOCX ▼]  (DOCX or PDF)
Template: [IPS Standard Peru ▼]
Language: [Spanish ▼]

API:

POST /api/v1/reports/pbrer
Body: {
  "ips_id": 456,
  "formato": "docx",
  "template": "standard_peru",
  "include_fichas": true
}

Response: Binary (DOCX file)

The system:

Loads template: app/templates/docs/IPS_REPORTE GENERAL.docx

Builds context:

# backend/app/routers/reports.py

context = {
  "meta": {"ips_id": 456, "version": "1.0", ...},
  "producto": {"nombre": "Paracetamol", ...},
  "fuentes": [
    {"source": "PubMed", "detected_total": 128, "items": [...]},
    ...
  ],
  "kpis": {
    "total_casos": 45,
    "casos_graves": 23,
    "casos_muerte": 0,
    "incidencia_hepatotoxicidad": 0.18
  },
  "firmas": {"elaborado_por": "Q.F. Juan Pérez", ...}
}

Renders with Jinja2:

from docxtpl import DocxTemplate

doc = DocxTemplate(template_path)
doc.render(context)
doc.save(output_path)

Optional: Convert to PDF via LibreOffice:

soffice --headless --convert-to pdf:writer_pdf_Export \
  --outdir /tmp output.docx

Review and Edit

Download the generated document. Review and edit:Sections to customize:

Executive summary (auto-generated is generic)
Benefit-risk conclusion
Signal interpretation
Recommendations

Automated sections (usually accurate):

Case counts and tables
Literature references
MedDRA coding summaries

Approve and Submit

Upload final version:

Upload Final: [Select File]
Approved By: [Q.F. María García ▼]
Submission Date: [2024-07-25 ▼]

API:

PUT /api/v1/ips/{ips_id}/submit
Body: {
  "version_final_url": "storage/ips/ips_456_final.pdf",
  "aprobado_por_id": 789,
  "fecha_envio": "2024-07-25"
}

The system:

Updates status to “Submitted”
Archives document
Schedules next period automatically
Sends notification to regulatory contact

DIGEMID Exports

Modelo B (Individual Case Report)

DIGEMID (Peru’s regulatory authority) requires specific formats for case submissions.

Select Cases for Export

Go to Cases > Export > Select cases:

Filters:
☑ Graves only
☑ Periodo: 2024-Q1
☑ Estado: Completado
☑ Not previously exported

Selected: 12 cases

Choose Export Format

Format: [DIGEMID Modelo B ▼]

Options:
- DIGEMID Modelo B (Individual PDF per case)
- DIGEMID Modelo B (Batch Excel)
- CIOMS Form (international standard)

Generate Export

Click Generate. The system:

POST /api/v1/icsr/export/{icsr_id}/digemid
Query: ?format=pdf&include_firma=true

# backend/app/routers/icsr_export.py

def generate_digemid_official_pdf(icsr, user):
    # Build context
    ctx = build_ctx_for_digemid(icsr)
    
    # Load template
    tpl = DocxTemplate("templates/DIGEMID_RAM_MODELO_B.docx")
    
    # Add firma (signature)
    firma_ctx = _build_firma_ctx(db, user)
    ctx.update(firma_ctx)
    
    # Render
    tpl.render(ctx)
    
    # Convert to PDF
    pdf_bytes = _to_pdf_with_libreoffice(tpl.get_docx())
    
    return pdf_bytes

Context fields:

ctx = {
  # Identificación
  "codigo_interno": "LAB-2024-001",
  "fecha_recepcion": "01/03/2024",
  
  # Paciente
  "paciente_iniciales": "J.P.",
  "paciente_edad": 45,
  "paciente_sexo": "M",
  "paciente_peso": 75,
  
  # Producto
  "producto_nombre": "Paracetamol 500mg",
  "producto_fabricante": "Lab XYZ",
  "producto_lote": "ABC123",
  "producto_registro": "EE-12345",
  
  # Evento
  "evento_descripcion": "...",
  "evento_fecha_inicio": "28/02/2024",
  "evento_gravedad": "Grave",
  "evento_criterios": ["Hospitalización"],
  "evento_desenlace": "Recuperado",
  
  # Causalidad
  "causalidad": "Probable",
  
  # Firma
  "firma_nombre": "Q.F. Juan Pérez",
  "firma_cargo": "Responsable de Farmacovigilancia",
  "firma_fecha": "25/03/2024",
  "firma_imagen_path": "storage/firmas/qf_jperez.png"
}

Download and Submit

Download generated files:

✓ ICSR_123_DIGEMID_Modelo_B.pdf (245 KB)
✓ ICSR_124_DIGEMID_Modelo_B.pdf (198 KB)
...
✓ BATCH_SUMMARY.xlsx (12 cases)

Submit to DIGEMID:

Via online portal: https://www.digemid.minsa.gob.pe/
Via email: [email protected]
In person (for serious cases)

Record Submission

Mark cases as exported:

PATCH /api/v1/icsr/{icsr_id}
Body: {
  "exportado_digemid": true,
  "fecha_export_digemid": "2024-03-25",
  "digemid_folio": "2024-0012345"  // DIGEMID tracking number
}

Reporting Timelines (DIGEMID)

Event Type	Timeline	Submission Method
Fatal	15 calendar days	Electronic + physical
Serious (non-fatal)	30 calendar days	Electronic
Non-serious	Quarterly reports	Electronic batch
Unexpected serious	15 calendar days	Electronic + physical

Custom Document Templates

Creating Templates

VIGIA uses DocxTemplate (python-docx-template) for DOCX generation.

Prepare Base Document

Create a DOCX file in Microsoft Word with:

Desired layout and styles
Placeholder tables (if needed)
Images/logos (static content)

Add Jinja2 Placeholders

Insert dynamic fields using Jinja2 syntax:Simple variables:

Producto: {{ producto_nombre }}
Período: {{ periodo_inicio }} al {{ periodo_fin }}
Total Casos: {{ total_casos }}

Conditionals:

{% if casos_graves > 0 %}
⚠️ Se detectaron {{ casos_graves }} casos graves.
{% else %}
✓ No se reportaron casos graves en este período.
{% endif %}

Loops:

{% for caso in casos %}
- Caso #{{ caso.id }}: {{ caso.evento }} ({{ caso.gravedad }})
{% endfor %}

Tables (use subdoc):

{{ cuadro_resumen_tbl }}  {# Generated programmatically #}

Upload Template

Save template to:

backend/app/templates/docs/IPS_Custom_Template.docx

POST /api/v1/admin/templates
Body: {
  "nombre": "IPS Custom",
  "tipo": "ips",
  "ruta": "docs/IPS_Custom_Template.docx",
  "descripcion": "Custom template for Product X"
}

Test Rendering

Generate a test report:

POST /api/v1/reports/test-render
Body: {
  "template_id": 5,
  "ips_id": 123
}

Response: Binary (DOCX)

Review output for:

All variables populated
Formatting preserved
Tables/loops correct
Images loaded

Template Variables Reference

IPS/PSUR Templates:

{
  # Meta
  "ips_id": str,
  "version": str,
  "estado": str,
  "periodo_inicio": date,
  "periodo_fin": date,
  "fecha_corte": date,
  "fecha_busqueda": date,
  "emitido_en": str,
  
  # Product
  "producto_nombre": str,
  "producto_principio": str,
  "producto_presentacion": str,
  "producto_via": str,
  "producto_registro": str,
  "producto_fabricante": str,
  
  # Sources
  "fuentes": [
    {
      "source": str,
      "detected_total": int,
      "items": [
        {"title": str, "journal": str, "year": int, "url": str}
      ]
    }
  ],
  
  # KPIs
  "total_casos": int,
  "casos_graves": int,
  "casos_muerte": int,
  "incidencia_<event>": float,
  
  # Signatures
  "elaborado_por": str,
  "revisado_por": str,
  "aprobado_por": str,
  "cargo_elabora": str,
  "cargo_revisa": str,
  "cargo_aprueba": str,
  "empresa_nombre": str,
  "empresa_direccion": str
}

DIGEMID Templates:

{
  # Case identification
  "codigo_interno": str,
  "fecha_recepcion": str,
  "numero_notificacion": str,
  
  # Patient
  "paciente_iniciales": str,
  "paciente_edad": int,
  "paciente_sexo": str,
  "paciente_peso": float,
  
  # Product
  "producto_nombre": str,
  "producto_principio": str,
  "producto_fabricante": str,
  "producto_lote": str,
  "producto_registro": str,
  "producto_dosis": str,
  "producto_via": str,
  
  # Event
  "evento_descripcion": str,
  "evento_fecha_inicio": str,
  "evento_fecha_fin": str,
  "evento_gravedad": str,
  "evento_criterios": list[str],
  "evento_desenlace": str,
  
  # Causality
  "causalidad": str,
  
  # Signature
  "firma_nombre": str,
  "firma_cargo": str,
  "firma_fecha": str,
  "firma_imagen_path": str  # Path to signature PNG
}

Report Calendar Management

Automated Scheduling

VIGIA automatically schedules IPS reports based on product registration:

Configure Product Schedule

In Products > > IPS Schedule:

Reporting Frequency: [Quarterly ▼]

Options:
- Quarterly (every 3 months)
- Semi-annual (every 6 months)
- Annual (yearly)
- Custom (define periods manually)

Start Date: [2024-01-01 ▼]  (product launch or IBD)
Submission Deadline: [+45 days after period end ▼]

Auto-generation

The system creates calendar entries:

# backend/app/services/ips_calendario.py

def generate_ips_calendar(product, frequency, start_date):
    periods = calculate_periods(frequency, start_date)
    
    for period in periods:
        IPS(
          producto_id=product.id,
          periodo_tipo=frequency,
          periodo_inicio=period.start,
          periodo_fin=period.end,
          fecha_limite=period.end + timedelta(days=45),
          estado="Pendiente"
        )

Email Reminders

VIGIA sends reminders:

30 days before: “IPS Q2 2024 due in 30 days”
7 days before: “IPS Q2 2024 due in 7 days (urgent)”
On due date: “IPS Q2 2024 submission deadline is today”
Overdue: “IPS Q2 2024 is overdue by 5 days”

Batch Operations

Exporting Multiple Cases

Select Cases

In Cases list, use checkboxes to select multiple casesBulk selection:

☑ Select all on page (10)
☑ Select all matching filters (45)

Choose Batch Action

Actions: [Export ▼]

Options:
- Export to Excel
- Export to DIGEMID (batch)
- Generate PDFs (zip)
- Update status

Configure Export

For Excel export:

Columns: [All ▼]
Format: [XLSX ▼]
Include: ☑ MedDRA codes ☑ Causality ☑ Followup notes

API:

POST /api/v1/icsr/export/batch
Body: {
  "icsr_ids": [123, 124, 125, ...],
  "format": "xlsx",
  "columns": ["id", "fecha_recepcion", "producto", ...]
}

Download Results

✓ BATCH_EXPORT_2024-03-25.xlsx (45 cases, 2.4 MB)

Excel includes:

All selected cases (one row per case)
Configured columns
MedDRA codes
Causality assessments
Export timestamp

API Reference

# IPS/PSUR
POST /api/v1/ips
GET /api/v1/ips/{ips_id}
PUT /api/v1/ips/{ips_id}/submit
POST /api/v1/reports/pbrer

# DIGEMID Export
POST /api/v1/icsr/export/{icsr_id}/digemid?format=pdf
GET /api/v1/icsr/export/{icsr_id}/modelo-b

# Batch Operations
POST /api/v1/icsr/export/batch
Body: {"icsr_ids": [...], "format": "xlsx"}

# Calendar
GET /api/v1/ips/calendario?year=2024
POST /api/v1/ips/calendario/generate

# Templates
GET /api/v1/admin/templates
POST /api/v1/admin/templates
POST /api/v1/reports/test-render

See API Reference for complete endpoint documentation.

Get Started

Core Features

User Guides

Modules

Regulatory

Administration

Generating Reports

Overview

IPS/PSUR Report Generation

Overview

Workflow

DIGEMID Exports

Modelo B (Individual Case Report)

Reporting Timelines (DIGEMID)

Custom Document Templates

Creating Templates

Template Variables Reference

Report Calendar Management

Automated Scheduling

Batch Operations

Exporting Multiple Cases

API Reference

Build docs developers (and LLMs) love

Get Started

Core Features

User Guides

Modules

Regulatory

Administration

​Overview

​IPS/PSUR Report Generation

​Overview

​Workflow

​DIGEMID Exports

​Modelo B (Individual Case Report)

​Reporting Timelines (DIGEMID)

​Custom Document Templates

​Creating Templates

​Template Variables Reference

​Report Calendar Management

​Automated Scheduling

​Batch Operations

​Exporting Multiple Cases

​API Reference

Build docs developers (and LLMs) love

Overview

IPS/PSUR Report Generation

Overview

Workflow

DIGEMID Exports

Modelo B (Individual Case Report)

Reporting Timelines (DIGEMID)

Custom Document Templates

Creating Templates

Template Variables Reference

Report Calendar Management

Automated Scheduling

Batch Operations

Exporting Multiple Cases

API Reference