ICH E2A
E555157
ICH E2A is an International Council for Harmonisation guideline that standardizes clinical safety data management and expedited reporting of adverse drug reactions in clinical trials.
Statements (46)
| Predicate | Object |
|---|---|
| instanceOf |
ICH guideline
ⓘ
pharmacovigilance guideline ⓘ regulatory guideline ⓘ |
| abbreviationOf | International Council for Harmonisation guideline E2A NERFINISHED ⓘ |
| addresses |
assessment of causality for adverse drug reactions
ⓘ
follow-up information for safety reports ⓘ reporting of fatal or life-threatening events ⓘ reporting of unexpected serious adverse drug reactions ⓘ sponsor responsibilities for safety reporting ⓘ |
| aimsTo |
provide consistent definitions for safety data in clinical trials
ⓘ
reduce duplication of safety reporting requirements across regions ⓘ |
| appliesTo | clinical trials ⓘ |
| defines |
adverse drug reaction
ⓘ
adverse event ⓘ expedited report ⓘ life-threatening adverse drug reaction ⓘ medically important serious event ⓘ serious adverse drug reaction ⓘ serious adverse event ⓘ unexpected adverse drug reaction ⓘ |
| focusesOn |
clinical safety data management
ⓘ
expedited reporting of adverse drug reactions ⓘ |
| fullTitle | Clinical Safety Data Management: Definitions and Standards for Expedited Reporting NERFINISHED ⓘ |
| implementedIn |
European Union pharmacovigilance legislation
ⓘ
Japan regulatory safety reporting requirements ⓘ United States FDA safety reporting regulations for clinical trials ⓘ |
| issuedBy | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use NERFINISHED ⓘ |
| language | English ⓘ |
| objective |
harmonisation of clinical safety reporting requirements
ⓘ
improvement of protection of clinical trial subjects ⓘ |
| partOf | ICH E2 clinical safety guidelines series NERFINISHED ⓘ |
| regulatoryArea | human medicines ⓘ |
| relatedTo |
ICH E2B
ⓘ
ICH E2C ⓘ ICH E2D ⓘ ICH E2E ⓘ |
| scope |
interventional clinical studies
ⓘ
investigational medicinal products in clinical trials ⓘ |
| standardizes |
criteria for expedited reporting
ⓘ
minimum information for safety reports ⓘ terminology for clinical safety reporting ⓘ timelines for expedited reporting ⓘ |
| usedBy |
clinical trial sponsors
ⓘ
pharmaceutical companies ⓘ pharmacovigilance professionals ⓘ regulatory authorities ⓘ |
Referenced by (1)
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