# OnCo record eu-clinical-trials-regulation (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/eu-clinical-trials-regulation/>
  a schema:DefinedTerm ;
  onco:kind "term" ;
  schema:identifier "eu-clinical-trials-regulation" ;
  schema:name "Clinical Trials Regulation (EU) No 536/2014 and CTIS"@en ;
  schema:alternateName "Clinical Trials Regulation"@en, "Regulation 536/2014"@en, "CTR"@en, "CTIS"@en, "Clinical Trials Information System"@en, "Clinical Trials Directive"@en, "Directive 2001/20/EC"@en, "ACT EU"@en ;
  schema:description "The EU rule, in force since January 2022, under which a cancer trial is submitted once through a single portal for all the countries it will run in, with results made public, replacing a 2001 directive that made every country's approval separate."@en ;
  schema:url <https://onco.cc/terms/eu-clinical-trials-regulation/> ;
  schema:dateModified "2026-09-17"^^xsd:date ;
  schema:sameAs <https://en.wikipedia.org/wiki/European_Union_Clinical_Trials_Regulation> ;
  schema:citation <https://en.wikipedia.org/wiki/European_Union_Clinical_Trials_Regulation>, <https://eur-lex.europa.eu/eli/reg/2014/536/oj>, <https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-regulation>, <https://euclinicaltrials.eu/> ;
  onco:tag "law", "eu" ;
  onco:related <https://onco.cc/terms/clinical-trial/>, <https://onco.cc/terms/common-rule/>, <https://onco.cc/terms/ich-gcp/>, <https://onco.cc/terms/declaration-of-helsinki/>, <https://onco.cc/terms/gdpr/>, <https://onco.cc/terms/eu-regulation-726-2004/>, <https://onco.cc/technologies/decentralised-clinical-trials/> ;
  onco:institutions <https://onco.cc/institutions/ema/> ;
  onco:bottlenecks <https://onco.cc/bottlenecks/b-trial-enrolment/>, <https://onco.cc/bottlenecks/b-regulatory-fragmentation/> .