Followup Management

Effective followup is critical for obtaining complete case information and ensuring high-quality safety data. VIGIA automates followup scheduling, tracks communications, and manages missing data requests.

Overview

VIGIA’s followup system provides:

Automated Scheduling: ICH E2D guideline-compliant followup timelines (Day 0, 30, 60, 90)
Multi-channel Communication: Email, SMS, WhatsApp
Missing Data Detection: AI-powered identification of incomplete fields
Thread Management: Complete communication history per case
Status Tracking: Pending, Sent, Responded, Completed

Followup Workflow

Initiating Followup

Access Case Details

Open the case requiring followup:URL: /casos/{icsr_id}

Navigate to Followup Tab

Click Seguimiento (Followup) tabThe interface shows:

Message Thread: All sent and received messages
Followup Plan: Scheduled attempts and their status
Missing Data: Detected incomplete fields
Quick Actions: Send message, schedule attempt, mark complete

Review Missing Data

VIGIA automatically detects missing critical fields:

compute_missing(icsr) → {
  "paciente": ["peso", "fecha_nacimiento"],
  "producto": ["dosis", "via_administracion"],
  "evento": ["fecha_fin", "desenlace"],
  "reporter": ["profesion"]
}

The UI displays:

Información Faltante (4 campos)

Paciente:

Peso
Fecha de nacimiento exacta

Producto:

Dosis exacta y frecuencia
Vía de administración

Evento:

Fecha de resolución
Desenlace actual

Generate Followup Message

Click Generate Request. The system auto-generates a message:

build_missing_email_body(icsr, missing_fields) → str

Example output:

Estimado(a) reportante,

Gracias por notificar el evento adverso relacionado con Paracetamol.
Para completar la evaluación del caso, necesitamos la siguiente información adicional:

INFORMACIÓN DEL PACIENTE:
- Peso aproximado
- Fecha de nacimiento (o edad exacta)

INFORMACIÓN DEL MEDICAMENTO:
- Dosis administrada (mg o tabletas)
- Vía de administración (oral, inyectable, etc.)

INFORMACIÓN DEL EVENTO:
- ¿Cuándo se resolvió el evento? (fecha aproximada)
- Estado actual del paciente (recuperado, en recuperación, etc.)

Puede responder a este correo con la información.

Atentamente,
Departamento de Farmacovigilancia

Select Channel

Choose communication channel based on reportante_contacto:Available channels:

Channel: [Email ▼]

Options:
- Email (recommended)
- SMS
- WhatsApp

The system extracts contact info:

extract_channels(icsr.reportante_contacto) → {
  "email": "[email protected]",
  "phone": "+51999999999",
  "whatsapp": "+51999999999"
}

Send Message

Click Send. The system:

Sends via selected channel:

POST /api/v1/icsr/{icsr_id}/followup/send
Body: {
  "channel": "email",
  "body": "...",
  "subject": "[VIGIA] Solicitud de información - ICSR #123"
}

Logs outbound message:

FollowupMessage(
  icsr_id=123,
  channel="email",
  direction="out",
  body="...",
  external_id="<[email protected]>",
  status="sent",
  created_at=datetime.now()
)

Updates case status:
- Changes estado from “Pendiente” to “En proceso”
- Records followup attempt

Email threading: Uses RFC 2822 headers for thread continuity:

In-Reply-To: <previous-message-id>
References: <msg-1> <msg-2> <msg-3>

Schedule Next Attempt

If no response, schedule the next followup:Click Schedule > Select date:

Next Attempt: [2024-04-05 ▼] (30 days from now)

Standard timeline (ICH E2D):

Day 0: Initial request (sent)
Day 30: First followup
Day 60: Second followup
Day 90: Final followup
Day 120: Close case if no response

Automated Followup Plans

Creating a Followup Plan

VIGIA can automatically schedule multiple attempts:

Define Plan Template

In Admin > Settings > Followup Plans, create a template:

{
  "name": "Standard ICH E2D",
  "ref": "8.4.1",
  "attempts": [
    {"label": "Initial Request", "afterHours": 0},
    {"label": "First Followup", "afterHours": 720},    // 30 days
    {"label": "Second Followup", "afterHours": 1440},  // 60 days
    {"label": "Final Followup", "afterHours": 2160}    // 90 days
  ],
  "notes": "ICH E2D guideline compliance"
}

Assign Plan to Case

In the Seguimiento tab, click Apply Plan > select template:

Followup Plan: [Standard ICH E2D ▼]

Base Date: [2024-03-01 ▼] (case reception date)

The system calculates absolute dates:

✓ Initial Request:    2024-03-01 (sent)
⏱ First Followup:    2024-03-31 (pending)
⏱ Second Followup:   2024-04-30 (pending)
⏱ Final Followup:    2024-05-30 (pending)

Automated Execution

VIGIA’s followup dispatcher runs daily:

# backend/app/services/followup_dispatch.py

def dispatch_due_followups():
    """Send followup messages for attempts due today"""
    due = get_attempts_due_today()
    
    for attempt in due:
        if attempt.status == "pending":
            send_followup_message(
                icsr_id=attempt.icsr_id,
                message=attempt.message,
                channel=attempt.channel
            )
            attempt.status = "sent"
            attempt.sent_at = datetime.now()

Cron schedule: 0 9 * * * (daily at 9 AM)

Manual Override

You can manually trigger or skip attempts:

Send Now: Click ▶ icon (sends immediately, ignores schedule)
Skip: Click ⏭ icon (marks as skipped, moves to next)
Reschedule: Click 📅 icon (change date)
Mark Complete: Click ✓ icon (if info received via other channel)

Message Thread Management

Viewing Communication History

The Seguimiento tab displays a chronological thread:

┌─────────────────────────────────────────────────────────┐
│ 📨 OUT | Email | 2024-03-01 10:15                      │
│ To: [email protected]                                │
│ Subject: [VIGIA] Solicitud de información - ICSR #123   │
│                                                          │
│ Estimado reportante,                                     │
│ Necesitamos información adicional sobre el caso...      │
│ [Show Full Message]                                      │
└─────────────────────────────────────────────────────────┘

┌─────────────────────────────────────────────────────────┐
│ 📬 IN | Email | 2024-03-05 14:32                       │
│ From: [email protected]                               │
│ Re: [VIGIA] Solicitud de información - ICSR #123        │
│                                                          │
│ Hola, adjunto la información solicitada:                │
│ - Peso: 68 kg                                            │
│ - Dosis: 500 mg cada 8 horas                             │
│ - Evento resuelto el 2024-02-28                          │
│ [Show Full Message] [Update Case]                       │
└─────────────────────────────────────────────────────────┘

┌─────────────────────────────────────────────────────────┐
│ 📨 OUT | Email | 2024-03-31 09:00                      │
│ To: [email protected]                                │
│ Subject: [VIGIA] Recordatorio - ICSR #123               │
│ [Scheduled - First Followup]                             │
└─────────────────────────────────────────────────────────┘

API Endpoint:

GET /api/v1/icsr/{icsr_id}/followup/thread

Response: {
  "items": [
    {
      "id": 1,
      "icsr_id": 123,
      "channel": "email",
      "direction": "out",
      "body": "...",
      "external_id": "<[email protected]>",
      "created_at": "2024-03-01T10:15:00Z"
    },
    ...
  ],
  "total": 2
}

Processing Inbound Responses

When a reporter responds via email:

Email Polling

VIGIA polls inbox for new messages:

# backend/app/services/email_ingestion.py

def poll_inbox():
    messages = fetch_new_emails()
    
    for msg in messages:
        # Check if In-Reply-To matches existing case
        parent_id = msg.headers.get("In-Reply-To")
        icsr = find_icsr_by_message_id(parent_id)
        
        if icsr:
            log_inbound_message(icsr.id, msg)
            notify_evaluator(icsr)

Message Logging

Inbound message is added to thread:

FollowupMessage(
  icsr_id=123,
  channel="email",
  direction="in",
  body=msg.body,
  external_id=msg.message_id,
  external_meta=json.dumps({
    "from": msg.from_address,
    "subject": msg.subject,
    "references": msg.references
  })
)

Notification

Assigned evaluator receives alert:Email:

Subject: [VIGIA] Respuesta recibida - ICSR #123

El reportante ha respondido a la solicitud de seguimiento.

Caso: #123
Producto: Paracetamol

Revisa la respuesta en VIGIA y actualiza el caso.

Dashboard badge:

Casos (3 nuevas respuestas) 🔴

Manual Update

Evaluator reviews response and updates case:

Open case detail
Click Update from Followup (auto-fill available)
Review extracted data
Save changes
Mark followup as Completed

Multi-Channel Support

Email (Recommended)

Advantages:

Threaded conversations (In-Reply-To headers)
Attachment support
Professional appearance
Audit trail

Configuration: See Case Intake - Email

SMS

Use cases:

Quick reminders
No email available
Rural areas with limited internet

Limitations:

160 character limit (split into multiple for longer messages)
No attachments
Higher cost per message

Setup:

Configure SMS gateway in Admin > Settings > SMS
Supported providers: Twilio, AWS SNS, local SMS gateway
Set reportante_contacto to phone number format: +51999999999

Sending:

POST /api/v1/icsr/{icsr_id}/followup/send
Body: {
  "channel": "sms",
  "body": "VIGIA: Necesitamos info adicional del caso #123. Responda o llame al 01-234-5678."
}

Advantages:

High open rates (98%)
Multimedia support (images, documents)
Popular in Latin America
Read receipts

Requirements:

WhatsApp Business API account
Approved message templates (for proactive outreach)

Setup:

Get WhatsApp Business API credentials
Configure webhook: https://your-vigia.com/api/v1/webhooks/whatsapp
Create message templates in WhatsApp Manager
Approve templates (required for first contact)

Message Templates:

{
  "name": "followup_request",
  "language": "es",
  "components": [
    {
      "type": "body",
      "text": "Hola {{1}}, necesitamos información adicional sobre el caso {{2}}. ¿Puede proporcionarnos {{3}}?"
    }
  ]
}

Sending:

POST /api/v1/icsr/{icsr_id}/followup/send
Body: {
  "channel": "whatsapp",
  "template": "followup_request",
  "parameters": ["Juan", "#123", "la dosis del medicamento"]
}

Followup Status Tracking

Status Values

Status	Meaning	Actions
Pending	Scheduled but not sent	Send now, Reschedule, Skip
Sent	Message delivered	Wait for response, Resend
Responded	Reporter replied	Update case, Mark complete
Completed	Info received and case updated	Archive
Skipped	Manually skipped	Re-activate if needed
Failed	Delivery failed (bounce, invalid address)	Update contact, Retry

Updating Status

Automatically:

Pending → Sent when message is delivered
Sent → Responded when reply received (email threading)
Responded → Completed when case updated

Manually:

PATCH /api/v1/icsr/{icsr_id}/followup/{message_id}
Body: {"status": "completed"}

Closing Followup

When to Close

Close followup when:

✅ All missing information obtained
✅ Case is complete and ready for reporting
⏰ Maximum attempts reached (e.g., 90 days, no response)
🚫 Reporter explicitly declined to provide more info
🚫 Reporter is unreachable (invalid contact info)

Closure Workflow

Mark as Complete

In Seguimiento tab, click Close Followup

Select Closure Reason

Reason: [Info Complete ▼]

Options:
- Info Complete (all data obtained)
- Max Attempts Reached (no response after 90 days)
- Reporter Declined
- Reporter Unreachable
- Case Closed (duplicate, invalid, etc.)

Add Closure Notes

Document the outcome:

Closure Notes:
Información completa obtenida tras segundo seguimiento.
Paciente confirmó recuperación total sin secuelas.
Caso listo para reporte DIGEMID.

Update Case Status

The system:

Sets followup_status = "Closed"
Updates estado = "Completado" (if all required info present)
Cancels pending scheduled attempts
Logs closure in audit trail

Quality Assurance

Before closing followup:

All critical missing fields addressed or documented as unavailable

Minimum 2 attempts made (Day 0 + Day 30) for serious cases

Final status clear: Complete, No Response, or Declined

Closure notes document outcome and any outstanding issues

Case ready for next workflow step (causality, reporting)

Troubleshooting

Reporter not receiving emails

Check:

Email address correct in reportante_contacto
Check spam/junk folder (ask reporter)
Verify SMTP send logs: backend/logs/mail.log
Test email delivery: POST /api/v1/admin/mail/test

Fix:

Update email address if incorrect
Add VIGIA domain to reporter’s whitelist
Use alternative channel (SMS, WhatsApp)

Email thread not linking correctly

Cause: Missing or incorrect In-Reply-To headerFix:

Check that external_id is saved when sending
Verify mail server supports RFC 2822 headers
Manual linking: In message thread, click Link and select parent message

Scheduled followups not sending

Check:

Cron job running: systemctl status vigia-followup-dispatcher
Logs: backend/logs/followup_dispatch.log
Attempt status: should be “pending” not “skipped”

Fix:

# Manually trigger dispatcher
python -m app.tasks.followup_dispatch

# Or via API
POST /api/v1/admin/followup/dispatch

API Reference

# Get followup thread
GET /api/v1/icsr/{icsr_id}/followup/thread

# Send followup message
POST /api/v1/icsr/{icsr_id}/followup/send
Body: {"channel": "email", "body": "..."}

# Update message status
PATCH /api/v1/icsr/{icsr_id}/followup/{message_id}
Body: {"status": "completed"}

# Apply followup plan
POST /api/v1/icsr/{icsr_id}/followup/plan
Body: {"plan_id": 1, "base_at": "2024-03-01T00:00:00Z"}

# Close followup
POST /api/v1/icsr/{icsr_id}/followup/close
Body: {"reason": "complete", "notes": "..."}

Get Started

Core Features

User Guides

Modules

Regulatory

Administration

Followup Management

Overview

Followup Workflow

Initiating Followup

Información Faltante (4 campos)

Automated Followup Plans

Creating a Followup Plan

Message Thread Management

Viewing Communication History

Processing Inbound Responses

Multi-Channel Support

Email (Recommended)

SMS

WhatsApp

Followup Status Tracking

Status Values

Updating Status

Closing Followup

When to Close

Closure Workflow

Quality Assurance

Troubleshooting

API Reference

Build docs developers (and LLMs) love

Get Started

Core Features

User Guides

Modules

Regulatory

Administration

​Overview

​Followup Workflow

​Initiating Followup

Información Faltante (4 campos)

​Automated Followup Plans

​Creating a Followup Plan

​Message Thread Management

​Viewing Communication History

​Processing Inbound Responses

​Multi-Channel Support

​Email (Recommended)

​SMS

​WhatsApp

​Followup Status Tracking

​Status Values

​Updating Status

​Closing Followup

​When to Close

​Closure Workflow

​Quality Assurance

​Troubleshooting

​API Reference

Build docs developers (and LLMs) love

Overview

Followup Workflow

Initiating Followup

Automated Followup Plans

Creating a Followup Plan

Message Thread Management

Viewing Communication History

Processing Inbound Responses

Multi-Channel Support

Email (Recommended)

SMS

WhatsApp

Followup Status Tracking

Status Values

Updating Status

Closing Followup

When to Close

Closure Workflow

Quality Assurance

Troubleshooting

API Reference