The meeting in Nicosia, Cyprus (May 16-18, 2012) was held with a double purpose: to train partners on GCP in paediatric clinical trial and to get everyone acquainted with the final protocols of the DEEP-1 and DEEP-3 studies and about the trial related procedures. In particular, the training workshop was aimed at ensuring compliance of the GCP according to EU Directive 2001/20/EC, and the EU Directive 2005/28/EC.
Particular attention was paid to countries outside the European Community to ensure that standardised rules, compliant to the Directive 2001/20/EC, are followed. During the Investigator Meeting, all subject involved (Investigators, CRO, Pharmacovigilance Team) had the opportunity to meet and interact.
Some of the activities that were discussed during the meeting are:
• Study visits and randomization procedures
• Sponsor/Investigator responsibilities
• Informed consent process