One of the main features of the Clinical Trials Regulation (CTR) EU No 536/2014 repealing the Clinical Trials Directive is the creation of the EU portal and the EU database for clinical trials, which are intended to simplify and harmonize the submission, assessment and reporting of clinical trials. This Regulation gives the European Medicines Agency the responsibility to prepare, in collaboration with the Member States and the European Commission, the functional specifications for these systems. The application of the Regulation will take place after an audit of the EU portal and the EU database has shown these systems are fully functional. This audit will be based on the functional specifications outlined in the attached draft document. This document was published Oct 10, with comments accepted until Oct 31, 2014.
Draft: Functional specifications for the EU portal and EU database to be audited published for comments