Adverse Event Reporting Systems
Post-market systems for collecting, analyzing, and acting on reports of suspected drug side effects and safety signals.
Core metadata
- ID: adverse_event_reporting_systems
- Era: Modern
- First known date: 1968 (decade)
- Region: United States, WHO member states, and global medicine regulation
- Review status: source_checked
- Maturity: established
Prerequisites
- Database Management Systems (database_management_systems)
- Clinical Medicine (medicine_clinical)
- Public Health Statistics (public_health_statistics)
Dependents
- Phase I-III Clinical Trials (phase_i_iii_clinical_trials)
- Real-World Evidence Regulatory Science (real_world_evidence_regulatory_science)
Fields
Field lanes
- Pharmaceuticals & Drug Development: Pharmacovigilance & Real-World Evidence
Node sources
- FDA Adverse Event Reporting System (U.S. Food and Drug Administration, 2026, official_agency) • Supports: node, maturity
Prerequisite edge evidence
Edge/source evidence summary:
- Prerequisite edges: 3
- Average edge confidence: 68%
- Prerequisite sources: 3
- expert_inference: 3
| Prerequisite | Type | Confidence | Evidence level | Note | Sources |
|---|---|---|---|---|---|
| Clinical Medicine (medicine_clinical) | enabling | 68% | expert_inference | Clinical Medicine provides a capability that enables this technology without being the only possible path. |
|
| Database Management Systems (database_management_systems) | enabling | 68% | expert_inference | Adverse-event reporting systems require structured report storage and retrieval, but the 1960s pharmacovigilance lineage predates relational DBMS. |
|
| Public Health Statistics (public_health_statistics) | enabling | 68% | expert_inference | Public Health Statistics provides a capability that enables this technology without being the only possible path. |
|
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