Triple

T22457995
Position Surface form Disambiguated ID Type / Status
Subject ICH M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals E555162 entity
Predicate partOf P40 FINISHED
Object International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines — 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: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines | Statement: [ICH M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals, partOf, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines]
NED1 Entity disambiguation (via context triple) gpt-5-mini-2025-08-07 
Target entity: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines
Context triple: [ICH M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals, partOf, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines]
  • A. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use chosen
    The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a global body that develops and promotes unified scientific and technical standards to ensure the safety, quality, and efficacy of medicines worldwide.
  • B. ICH Q11 Development and Manufacture of Drug Substances
    ICH Q11 Development and Manufacture of Drug Substances is an ICH guideline that provides principles and expectations for the development and manufacturing of chemical and biotechnological drug substances within a quality-by-design framework.
  • C. 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.
  • 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 Q10 Pharmaceutical Quality System
    ICH Q10 Pharmaceutical Quality System is an international guideline that establishes a comprehensive, lifecycle-based framework for pharmaceutical quality management to ensure consistent product quality and regulatory compliance.
  • 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_69f15b7d00208190955a70e2c22d25a4 completed April 29, 2026, 1:14 a.m.
Created at: April 16, 2026, 8:48 p.m.