{
  "node_id": "eu-clinical-trials-regulation-536-2014-ctr-investigational-medicinal-products",
  "title": "EU Clinical Trials Regulation 536/2014 (CTR) - Investigational Medicinal Products and Trial Authorisation",
  "domain": "Pharmaceuticals & Life Sciences",
  "version": "1.0.0",
  "last_updated": "2024-01-31",
  "bluf": "Regulation (EU) No 536/2014 establishes a harmonised EU-wide authorisation procedure for clinical trials on investigational medicinal products via the Clinical Trials Information System (CTIS)…",
  "paywall": {
    "status": "LOCKED",
    "unlock_cost_usd": "0.01",
    "skyfire_id": "41779894-ece2-4163-9761-b3b1b76e19b0"
  },
  "crosswalks": {
    "_available_keys": [
      "industry_mapping",
      "use_cases",
      "related_standards",
      "geographic_scope",
      "compliance_timeline"
    ],
    "_note": "Full crosswalk values included in vault response"
  },
  "dependencies": [
    "eu-good-manufacturing-practice-gdp-2013-c-343-4-medicinal-products",
    "eu-advanced-therapy-medicinal-products-regulation-1394-2007"
  ],
  "primary_citations_count": 5,
  "workflow_steps_count": 10,
  "schema_fields_count": 18,
  "citation_preview": [
    {
      "title": "Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use",
      "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014R0536",
      "section": "Article 5 (submission), Article 41 (SAE reporting), Article 37 (results)"
    },
    {
      "title": "EMA Clinical Trials Information System (CTIS) guidance",
      "url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-information-system-ctis",
      "section": "Sponsor registration and submission procedures"
    }
  ]
}