Triple

T22457026
Position Surface form Disambiguated ID Type / Status
Subject ICH E8 General Considerations for Clinical Trials E555142 entity
Predicate hasFullTitle P1116 FINISHED
Object ICH Harmonised Guideline E8: General Considerations for Clinical Trials — 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 Harmonised Guideline E8: General Considerations for Clinical Trials | Statement: [ICH E8 General Considerations for Clinical Trials, hasFullTitle, ICH Harmonised Guideline E8: General Considerations for Clinical Trials]
NED1 Entity disambiguation (via context triple) gpt-5-mini-2025-08-07 
Target entity: ICH Harmonised Guideline E8: General Considerations for Clinical Trials
Context triple: [ICH E8 General Considerations for Clinical Trials, hasFullTitle, ICH Harmonised Guideline E8: General Considerations for Clinical Trials]
  • A. ICH E8 General Considerations for Clinical Trials chosen
    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.
  • B. ICH E6 Good Clinical Practice
    ICH E6 Good Clinical Practice is an international ethical and scientific quality standard that governs the design, conduct, recording, and reporting of clinical trials involving human subjects.
  • C. ICH M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
    ICH M3(R2) is an international guideline that harmonizes requirements for nonclinical safety studies needed to support the initiation and progression of human clinical trials and the marketing authorization of pharmaceuticals.
  • D. ICH Q8 Pharmaceutical Development
    ICH Q8 Pharmaceutical Development is an international guideline that outlines a systematic, science- and risk-based approach to pharmaceutical product and process development, forming a core part of the ICH quality framework.
  • E. ICH Q1 Stability Testing of New Drug Substances and Products
    ICH Q1 Stability Testing of New Drug Substances and Products is an international regulatory guideline that defines the scientific principles and study requirements for assessing the stability, shelf life, and storage conditions of new pharmaceutical substances and finished products.
  • 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_69e11e51fdec8190adfdf9f8a6362221 completed April 16, 2026, 5:37 p.m.
NER Named-entity recognition batch_69f15b7c428c8190847a259eef969525 completed April 29, 2026, 1:14 a.m.
Created at: April 16, 2026, 8:48 p.m.