Ethical considerations for clinical trials on medicinal products conducted with minors. Recommendations of the expert group on clinical trials for the implementation of 12 Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (2017).

Published by EC

Clinical TrialsEthics CommitteeNeonateMinorAdolescentConsentAssent 

The document provides recommendations on various ethical aspects of clinical trials performed in children from birth up to the legal age of adulthood.

View this resource Bookmark this resource

Committee for Medicinal Products for Human Use (CHMP) and Paediatric Committee (PDCO). Guideline on The Investigation of Medicinal Products In The Term And Preterm Neonate. 2009 Doc. Ref. EMEA/536810/2008.

Published by European Medicines Agency

Clinical TrialsNeonateAdverse Effects

This guideline addresses the considerations and requirements for the design and conduct of clinical trials in premature and term neonates using medicinal products of relevance for the use by this population. It includes background information on the maturation of organs and of body functions.

View this resource Bookmark this resource