ICSR API Overview

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Introduction

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Base URL

/api/v1/icsr

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Authentication

• icsr:list - List and search cases
• icsr:read - View case details
• icsr:create - Create new cases
• icsr:update - Update existing cases
• icsr:delete - Delete cases (requires password confirmation)

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Key Features

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Case Management

• Create, read, update, and delete ICSR cases
• Manage patient information, products, and adverse events
• Track concomitant medications and followup history
• Support for multiple product entries per case

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Adverse Events

• Record multiple adverse events per case
• MedDRA coding support (LLT and PT terms)
• Event severity, causality, and outcome tracking
• Individual event-level metadata

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Duplicate Detection

• Automatic duplicate detection based on patient and event data
• Scoring algorithm using patient initials, DOB, event date, and product
• Manual override capabilities for duplicate decisions
• Bulk duplicate checking for multiple cases

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Followup Communications

• Email, SMS, and WhatsApp channel support
• Thread-based conversation tracking
• Automatic missing data detection and requests
• Message threading with In-Reply-To headers

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Export & Reporting

• DIGEMID format PDF export
• Causality assessment reports
• Case snapshots and audit trails

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Data Models

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ICSR Structure

• Patient Information: Demographics, initials, age, sex, weight, diagnosis
• Reporter Information: Name, contact details, occupation
• Product Information: Suspected products with registration details, batch numbers, dosing
• Event Information: Adverse event descriptions, dates, severity, outcomes
• Concomitant Medications: Other medications taken during the period
• Timeline: Receipt dates, submission deadlines, regulatory timelines
• Quality Control: Review status, signal detection, additional comments
• Followup History: Communication thread with reporter

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Event Structure

• Event text/description
• Start and end dates
• Severity classification (grave/no grave)
• Causality assessment
• Outcome/resolution status
• MedDRA coding (LLT and PT)
• Source documentation

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Pagination

• page - Page number (default: 1)
• page_size - Items per page (default: 20, max: 200)
• q - Full-text search query
• fecha_desde / fecha_hasta - Date range filters
• order_by - Sort field (default: “id”)
• order_dir - Sort direction (“asc” or “desc”, default: “desc”)

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Error Handling

• 200 - Success
• 201 - Created
• 400 - Bad request (validation error)
• 401 - Unauthorized
• 403 - Forbidden (insufficient permissions)
• 404 - Resource not found
• 409 - Conflict (e.g., duplicate detection)
• 500 - Internal server error

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Common Workflows

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Creating a New Case

1. POST to /api/v1/icsr with case data
2. System assigns internal ID and triggers notifications
3. Automatic duplicate detection runs in background
4. Missing data auto-reply sent if configured

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Managing Adverse Events

1. GET case details to retrieve existing events
2. PUT to /api/v1/icsr/{id}/eventos to replace all events
3. Individual event updates via /api/v1/icsr/{id}/eventos/{event_id}
4. MedDRA coding can be updated separately

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Handling Duplicates

1. GET /api/v1/icsr/{id}/duplicates to check for potential duplicates
2. Review matches and scores
3. PUT to /api/v1/icsr/{id}/dup to set manual decision
4. Mark as unique or link to master case

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Followup Communication

1. GET /api/v1/icsr/{id}/followup/thread to view message history
2. POST to /api/v1/icsr/{id}/followup/send to send new message
3. System handles email threading and external message IDs
4. Case status automatically updated from “Pendiente” to “En progreso”

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Rate Limits

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Next Steps

• Create Case - Create a new ICSR
• List Cases - Query and filter cases
• Update Case - Modify existing cases
• Manage Events - Add and update adverse events
• Followup - Handle reporter communications