Journal of cancer policyHumansItalyClinical Trials as TopicEuropean UnionNeoplasms
Investigational sites requirements according to trial complexity and intervention level under EU Regulation No. 536/2014.
Celeste Cagnazzo, Evaristo Maiello, Roberto Labianca, Valeria Facciolo, Francesco Perrone, Gennaro Daniele, Massimo Di Maio, Carmine Pinto
Published: 202510.1016/j.jcpo.2025.100655
Abstract
The full implementation of Regulation (EU) No. 536/2014 has transformed the European clinical research landscape, introducing a harmonised, risk-based framework for trial approval and conduct. In Italy, however, the lack of nationally standardised si…
Preview only. Read the full abstract at the source