# OnCo record ich-gcp (term). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)". Whole corpus: https://onco.cc/api/v1/onco.nt
@prefix schema: <https://schema.org/> .
@prefix onco: <https://onco.cc/ns#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

<https://onco.cc/terms/ich-gcp/>
  a schema:DefinedTerm ;
  onco:kind "term" ;
  schema:identifier "ich-gcp" ;
  schema:name "ICH good clinical practice (E6)"@en ;
  schema:alternateName "ICH GCP"@en, "ICH E6"@en, "E6(R2)"@en, "E6(R3)"@en, "good clinical practice"@en, "GCP"@en, "International Council for Harmonisation"@en, "ICH guidelines"@en, "ICH E9"@en, "estimands"@en ;
  schema:description "The international standard for how a clinical trial must be designed, run, recorded and reported so that regulators in the United States, Europe, Japan and now China will accept its data; the third version was adopted in 2025 to fit trials that use electronic records and run across many countries."@en ;
  schema:url <https://onco.cc/terms/ich-gcp/> ;
  schema:dateModified "2026-09-17"^^xsd:date ;
  schema:sameAs <https://en.wikipedia.org/wiki/Good_clinical_practice> ;
  schema:citation <https://en.wikipedia.org/wiki/Good_clinical_practice>, <https://www.ich.org/page/efficacy-guidelines> ;
  onco:tag "law", "intl" ;
  onco:related <https://onco.cc/terms/declaration-of-helsinki/>, <https://onco.cc/terms/common-rule/>, <https://onco.cc/terms/eu-clinical-trials-regulation/>, <https://onco.cc/terms/clinical-trial/>, <https://onco.cc/terms/china-drug-administration-law/>, <https://onco.cc/terms/india-new-drugs-rules-2019/>, <https://onco.cc/terms/project-orbis/>, <https://onco.cc/technologies/decentralised-clinical-trials/>, <https://onco.cc/terms/primary-endpoint/> ;
  onco:institutions <https://onco.cc/institutions/fda-oce/>, <https://onco.cc/institutions/ema/>, <https://onco.cc/institutions/pmda/>, <https://onco.cc/institutions/nmpa-cde/> ;
  onco:bottlenecks <https://onco.cc/bottlenecks/b-trial-enrolment/>, <https://onco.cc/bottlenecks/b-regulatory-fragmentation/> .