Triple
T22662116
| Position | Surface form | Disambiguated ID | Type / Status |
|---|---|---|---|
| Subject | ICH E2D |
E559691
|
entity |
| Predicate | relatedTo |
P37
|
FINISHED |
| Object | ICH E2C Periodic Benefit-Risk Evaluation Report (PBRER) |
—
|
NE NERFINISHED |
How this triple was built (2 steps)
Every LLM step that produced this triple, in pipeline order — named-entity classification, the disambiguation choices (the exact options shown, with the pick highlighted), and the generated description. The batch + timestamp of each is in the Provenance table below.
NER
Named-entity recognition
gpt-5-mini
Instruction
Given a phrase, classify it is english named entity (e.g., persons, organizations, works of art) in Latin script, or not (e.g., literals, dates, URLs, verbose phrases). For disambiguation, the statement where the phrase occurs as object is also given. Please return a JSON object with `phrase` (string, the phrase being analyzed) and `is_ne` (boolean, indicating whether the phrase is a Named Entity).
Input
Phrase: ICH E2C Periodic Benefit-Risk Evaluation Report (PBRER) | Statement: [ICH E2D, relatedTo, ICH E2C Periodic Benefit-Risk Evaluation Report (PBRER)]
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: ICH E2C Periodic Benefit-Risk Evaluation Report (PBRER) Context triple: [ICH E2D, relatedTo, ICH E2C Periodic Benefit-Risk Evaluation Report (PBRER)]
-
A.
Periodic Benefit-Risk Evaluation Report (PBRER)
chosen
The Periodic Benefit-Risk Evaluation Report (PBRER) is a standardized pharmacovigilance document used by pharmaceutical companies to periodically assess and summarize the evolving benefits and risks of a medicinal product throughout its lifecycle.
-
B.
Pharmacovigilance Risk Assessment Committee within the European Medicines Agency
The Pharmacovigilance Risk Assessment Committee within the European Medicines Agency is an expert body responsible for evaluating and monitoring the safety of medicines across the European Union and providing recommendations on managing and communicating medicine-related risks.
-
C.
International Council for Harmonisation guideline E2C
International Council for Harmonisation guideline E2C is a regulatory framework that provides standardized requirements for the ongoing safety evaluation and periodic benefit-risk assessment of marketed medicinal products.
-
D.
ICH E2A Clinical Safety Data Management
ICH E2A Clinical Safety Data Management is an international guideline that standardizes the collection, reporting, and evaluation of clinical safety data in drug development to support consistent pharmacovigilance and regulatory decision-making.
-
E.
ICH E8 General Considerations for Clinical Trials
ICH E8 General Considerations for Clinical Trials is an international guideline that outlines fundamental principles and quality considerations for the design, conduct, and evaluation of clinical studies across all phases of drug development.
- F. None of above.
- G. Unsure - the case is ambiguous/there is not enough information to decide.
Provenance (2 batches)
The batch behind each pipeline step, in order, with when it ran. Timestamps are batch-level — stages were processed in waves, so the object chain (NER → NED1 → NEDg → NED2) reads in order, but predicate / elicitation batches can sit in a different wave.
| Step | Stage | Batch ID | Status | When |
|---|---|---|---|---|
| creating | Elicitation | batch_69e2454a158c819093b8e35f5045efb6 |
completed | April 17, 2026, 2:35 p.m. |
| NER | Named-entity recognition | batch_69f1765fe7d081908087778c54c1e612 |
completed | April 29, 2026, 3:09 a.m. |
Created at: April 17, 2026, 3:08 p.m.