ICSR Atlas
A Comprehensive Reference for Individual Case Safety Report Fields
Abstract
This reference platform provides standardized field definitions and regulatory guidelines for Individual Case Safety Reports (ICSR) across major global jurisdictions. The system covers 237 fields organized into 11 sections, following the ICH E2B(R3) international standard.
Each regulatory authority may have additional fields or specific requirements. These country-specific variations are also provided.
1.Coverage Overview
| ICH Standard Version | E2B(R3) |
| Jurisdictions Covered | ICH, KR, US |
2.Regulatory Jurisdictions
| Code | Jurisdiction | Regulatory Authority |
|---|---|---|
| 🌐 | ICH E2B(R3) Standard | ICH |
| 🇰🇷 | Korea | MFDS |
| 🇺🇸 | United States | FDA |
3.Site Guide
| Page | Description |
|---|---|
| Field Detail | View field definitions, data types, business rules, and country-specific regulations. Select a field from sidebar search or section list. |
| Field Search | Search by field number (e.g., C.1.1) or keyword in the sidebar to navigate to the field detail page. |
4.Platform Capabilities
Field Search and Navigation
Search ICSR fields by field number, name, or description across all supported jurisdictions. The search functionality provides comprehensive coverage of field definitions, synonyms, and regulatory requirements.
5.References and Access
Platform Maintenance
This reference platform is developed and maintained by Dodlab for pharmacovigilance professionals worldwide. Content is regularly updated to reflect the latest regulatory guidelines and standards.
Standards Compliance
All field definitions and structures adhere to ICH E2B(R3) international standards and incorporate jurisdiction-specific requirements from FDA, EMA, PMDA, MFDS, and NMPA guidelines.
User Access
Basic field reference is available to all visitors. Advanced features including community contributions and personalized bookmarks will be available soon.