What Regulation (EU) No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use - Article 28: General rules requires
Organizations must ensure that for any clinical trial, the anticipated benefits justify the foreseeable risks, this balance is constantly monitored, and subjects or their legally designated representatives are properly informed.
Pillar: Biotech & Genomics · Authority: European Parliament and Council of the European Union · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32014R0536
SHA-256 integrity: 5c8dbb2969a8195f66397618917ac7de89919c5718c061b8dc3dd9d63008fa1b
Primary Citations — 5 traced to source
- Article 28(1): A clinical trial may be conducted only where all of the following conditions are met:
- Article 28(1)(a): the anticipated benefits to the subjects or to public health justify the foreseeable risks and inconveniences and compliance with this condition is constantly monitored;
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