ICH E6 Good Clinical Practice

E131969

Good Clinical Practice guideline clinical research guideline ethical guideline international standard scientific quality standard

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.

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All labels observed (4)

Label	Occurrences
Good Clinical Practice guidelines	2
ICH E6 Good Clinical Practice canonical	2
ICH E6 GCP	1
ICH Harmonised Guideline: Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2)	1

How this entity was disambiguated

This entity first appeared as the object of triple T1151207 — 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 E6 Good Clinical Practice
Context triple: [International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, notableWork, ICH E6 Good Clinical Practice]

A. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
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. 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. ISO 14971
ISO 14971 is an international standard that specifies a systematic process for risk management of medical devices throughout their life cycle.
D. GAC Principles and Guidelines
GAC Principles and Guidelines are a set of policy frameworks and best-practice recommendations developed to guide governments’ participation and advice on public policy issues related to the global Domain Name System within ICANN.
E. Committee for Proprietary Medicinal Products
The Committee for Proprietary Medicinal Products was a former scientific committee of the European Union responsible for evaluating and issuing opinions on the quality, safety, and efficacy of human medicinal products before it was replaced by the European Medicines Agency’s current committee structure.
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 E6 Good Clinical Practice
Target entity description: 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.

A. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
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. 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. ISO 14971
ISO 14971 is an international standard that specifies a systematic process for risk management of medical devices throughout their life cycle.
D. GAC Principles and Guidelines
GAC Principles and Guidelines are a set of policy frameworks and best-practice recommendations developed to guide governments’ participation and advice on public policy issues related to the global Domain Name System within ICANN.
E. Committee for Proprietary Medicinal Products
The Committee for Proprietary Medicinal Products was a former scientific committee of the European Union responsible for evaluating and issuing opinions on the quality, safety, and efficacy of human medicinal products before it was replaced by the European Medicines Agency’s current committee structure.
F. None of above. chosen

Statements (50)

Predicate	Object
instanceOf	Good Clinical Practice guideline ⓘ clinical research guideline ⓘ ethical guideline ⓘ international standard ⓘ scientific quality standard ⓘ
aimsTo	ensure credibility of clinical trial data ⓘ ensure integrity of clinical trial data ⓘ ensure safety of clinical trial subjects ⓘ ensure well-being of clinical trial subjects ⓘ protect rights of clinical trial subjects ⓘ
appliesTo	clinical trials involving human subjects ⓘ pharmaceutical clinical development ⓘ
covers	clinical trial protocol content ⓘ investigator brochure content ⓘ statistical considerations in clinical trials ⓘ trial management ⓘ trial monitoring ⓘ
defines	responsibilities of independent ethics committees ⓘ responsibilities of institutional review boards ⓘ responsibilities of investigators ⓘ responsibilities of monitors ⓘ responsibilities of sponsors ⓘ
E6(R1)Finalised	1996 ⓘ
E6(R2)Adopted	2016 ⓘ
focusesOn	ethical aspects of clinical trials ⓘ scientific quality of clinical trials ⓘ
governs	conduct of clinical trials ⓘ design of clinical trials ⓘ recording of clinical trial data ⓘ reporting of clinical trial data ⓘ
hasAbbreviation	ICH E6 Good Clinical Practice self-linksurface differs ⓘ surface form: ICH E6 GCP
hasTitle	ICH E6 Good Clinical Practice self-linksurface differs ⓘ surface form: ICH Harmonised Guideline: Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2)
includes	requirements for data handling and record keeping ⓘ requirements for essential documents ⓘ requirements for informed consent ⓘ requirements for protocol compliance ⓘ requirements for quality assurance and quality control ⓘ requirements for safety reporting ⓘ
issuedBy	International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ⓘ
language	English ⓘ
partOf	International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ⓘ surface form: International Council for Harmonisation guidelines
recognizedBy	many regulatory authorities worldwide ⓘ regulatory authorities in ICH regions ⓘ
relatedTo	Good Clinical Practice ⓘ
supports	harmonisation of clinical trial standards ⓘ
usedFor	multinational clinical trials ⓘ registration of pharmaceuticals ⓘ
version	E6(R1) ⓘ E6(R2) ⓘ E6(R3) ⓘ

How these facts were elicited

Referenced by (6)

Full triples — surface form annotated when it differs from this entity's canonical label.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use → notableWork → ICH E6 Good Clinical Practice ⓘ

HIV Vaccine Trials Network → uses → ICH E6 Good Clinical Practice ⓘ

this entity surface form: Good Clinical Practice guidelines

ICH → notableGuideline → ICH E6 Good Clinical Practice ⓘ

ICH E6 Good Clinical Practice → hasAbbreviation → ICH E6 Good Clinical Practice self-linksurface differs ⓘ

this entity surface form: ICH E6 GCP

ICH E6 Good Clinical Practice → hasTitle → ICH E6 Good Clinical Practice self-linksurface differs ⓘ

this entity surface form: ICH Harmonised Guideline: Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2)

European medicines regulatory authorities → follows → ICH E6 Good Clinical Practice ⓘ