What EU GCP Directive 2005/28/EC and Clinical Trials Regulation 536/2014 - Good Clinical Practice in Clinical Trials requires
EU Good Clinical Practice (GCP) requirements established under Directive 2005/28/EC and now primarily governed by Clinical Trials Regulation (CTR) 536/2014 set the ethical and scientific quality standards for clinical trials in the EU. Core requirements include: ethics committee opinion and member state authorisation before trial commencement; informed consent from participants; trial conduct in compliance with the approved protocol; trial master file and investigator site file maintenance; serious adverse event (SAE) and suspected unexpected serious adverse reactions (SUSARs) reporting; GCP compliance inspections by national competent authorities; and registration in the EU Clinical Trials Information System (CTIS).
Pillar: Pharmaceuticals & Life Sciences · Authority: European Medicines Agency (EMA) · Version: 2.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014R0536
SHA-256 integrity: 6e3e970af3c8f4b341b901e7b0821487e4fcc0eeb41e4c7a74092dd1b0ba4e82
Primary Citations — 8 traced to source
- {"source":"EU Clinical Trials Regulation 536/2014 - Articles 28-35: Protection of Trial Subjects and Informed Consent","url":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014R0536","type":"primary_legislation"}
- {"source":"EU Clinical Trials Regulation 536/2014 - Articles 41-46: Safety Reporting and EudraVigilance Submission","url":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014R0536","type":"primary_legislation"}
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