Eudralex Volume 10 has been amended with guidelines concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT), and on EudraCT information to be made public.
The guideline lists the concrete data fields of the clinical trials database EudraCT to be made publicly available via the Web (accessible via the EudraPharm website and the EudraCT clinical trials public information website).
The Guideline is published in Chapter IV of the Eudralex Volume 10. Eudralex Volume 10 Clinical Trials – Notice to applicants (this is the official title) is based on the corresponding Directives (2001/20/EC, 2005/28/EC, 2003/94/EC) and summarises existing GCP and GMP guidelines/guidances.
Eudralex Volume 10 Clinical Trials can be found here.
On behalf of the European Compliance Academy (ECA)