What EU Clinical Trials Regulation 2014/536 - Authorisation and Conduct of Clinical Trials for Investigational Medicinal Products requires
Regulation (EU) No 536/2014 (Clinical Trials Regulation, CTR) replaced Directive 2001/20/EC and establishes a harmonised procedure for clinical trial authorisation across the EU via the Clinical Trials Information System (CTIS). Sponsors must obtain Ethics Committee and Member State authority approval; apply consistent GCP standards; report serious adverse events; and register trials on the EU Clinical Trials Register.
Pillar: Pharmaceuticals & Life Sciences · Authority: EUR-Lex - Official Journal of the European Union · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32014R0536
SHA-256 integrity: dfae7304ec247223a0ac98c34143c5f0fde0d965322fb8ee7cf21058d64c5fab
Primary Citations — 5 traced to source
- Arts. 5-10, 25, 42, 43, 63 - CTIS Submission, Assessment, Registration, SUSARs, DSUR, GMP — Regulation (EU) No 536/2014 - Clinical Trials Regulation (CTR)
- GCP principles; investigator, sponsor, and monitor responsibilities — ICH E6(R3) - Good Clinical Practice Guideline
+ 3 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
Access
- Discovery (free): /api/v1/nodes/eu-clinical-trials-regulation-2014-536-ctr-investigational-medicinal-products.json — 6-field metadata
- Vault (full node): /api/v1/vault/nodes/eu-clinical-trials-regulation-2014-536-ctr-investigational-medicinal-products.json — full 13-key payload, $0.01 USDC (L402/Skyfire/Direct Base)
- Canonical URL: https://bidda.com/intelligence/eu-clinical-trials-regulation-2014-536-ctr-investigational-medicinal-products
- Back to registry: Browse all 10,099 compliance nodes