Eudralex Volume 10 has been amended by recommendations on various ethical
aspects of clinical trials performed with children. These recommendations shall
contribute to the protection of children who are the subject of clinical trials.
Furthermore, the recommendations are intended to facilitate a harmonised
application of rules on clinical trials across the EU and thereby facilitate the
conduct of clinical trials in the EU. These recommendations are published in
Chapter V: Additional Information.
A summary of the consultation response can be found
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. Apart from
that, the document also includes recommendations in the form of recommendation
documents. Here, Chapter 6 "Recommendations on Inspections" is interesting,
since it reflects the EC's expectations of the inspectors in its member states.
Although mainly directed at GCP inspectorates, the document is also of interest
to all those who are looking for pointers and recommendations on how to train
their own, company-employed auditors.
It also includes the Guidance and other medicinal products used in clinical
trials. This document intends to clarify and provide additional guidance on the
definition of investigational medicinal products and to provide specific
guidance about the use of non-investigational medicinal products, in accordance
with the applicable EU legislation and lays down definitions agreed on by the
European Commission and the member states.
Eudralex Volume 10 Clinical Trials can be found on the following web page: