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.
All labels observed (1)
| Label | Occurrences |
|---|---|
| ICH E2A canonical | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T5932543 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: ICH E2A Context triple: [ICH E2A Clinical Safety Data Management, hasAbbreviation, ICH E2A]
-
A.
E-2A
E-2A was the Soviet spacecraft bus platform used for early Luna missions such as Luna 3, which photographed the Moon’s far side.
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B.
E.I.
"E.I." is a hit hip-hop single by American rapper Nelly from his debut album "Country Grammar."
-
C.
EICK
EICK is the ICAO airport code assigned to Cork Airport in Ireland.
-
D.
EIC
EIC is the common abbreviation for the British East India Company, the powerful trading corporation that played a central role in establishing British rule in India.
-
E.
EIC
EIC is a category of long-distance passenger trains in Poland, offering higher-standard intercity services operated by PKP Intercity.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
NED2
Entity disambiguation (via description)
gpt-5-mini-2025-08-07
Target entity: ICH E2A Target entity description: 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.
-
A.
E-2A
E-2A was the Soviet spacecraft bus platform used for early Luna missions such as Luna 3, which photographed the Moon’s far side.
-
B.
E.I.
"E.I." is a hit hip-hop single by American rapper Nelly from his debut album "Country Grammar."
-
C.
EICK
EICK is the ICAO airport code assigned to Cork Airport in Ireland.
-
D.
EIC
EIC is the common abbreviation for the British East India Company, the powerful trading corporation that played a central role in establishing British rule in India.
-
E.
EIC
EIC is a category of long-distance passenger trains in Poland, offering higher-standard intercity services operated by PKP Intercity.
- F. None of above. chosen
Statements (46)
| Predicate | Object |
|---|---|
| instanceOf |
ICH guideline
ⓘ
pharmacovigilance guideline ⓘ regulatory guideline ⓘ |
| abbreviationOf |
International Council for Harmonisation guideline E2A
ⓘ
linked to:
ICH E2A Clinical Safety Data Management
|
| 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
ⓘ
linked to:
ICH E2A Clinical Safety Data Management
|
| 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 ⓘ |
| language | English ⓘ |
| objective |
harmonisation of clinical safety reporting requirements
ⓘ
improvement of protection of clinical trial subjects ⓘ |
| partOf |
ICH E2 clinical safety guidelines series
ⓘ
linked to:
ICH E2A Clinical Safety Data Management
|
| 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 ⓘ |
How these facts were elicited
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
Instruction
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Input
Subject: ICH E2A Description of subject: 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.
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.