The last DEEP-2 Investigator Meeting was organised on April 14th 2016 in the framework of the 7th DEEP General Assembly in Padua. It was designed as a guided roundtable where CRAs and Principal Investigators from main recruiting sites had the opportunity to depict the situation at their own centre (based on the PPT Model sent out to PIs by email) and identify the main issues faced during the study. The discussion was leaded by the Trial Management Team (D. Bonifazi, B. Pantaleo, B. Tempesta), the Coordinating Investigator (A. Maggio), the Quality Assurance (S. Morgagni) and the Qualified Person for PharmacoVigilance (M. Felisi).
In particular, CRAs and PIs highlighted the strengths and weaknesses encountered in the study conduction with particular reference to the following issues:
• Informed consent procedure
• Planning study visits
• IMPs handling
• Dose adjustments for Safety and Efficacy reasons
• Periodic assessments for Safety
• Data entry in e-CRF
• Collection of Ferritin Samples for centralized evaluations and MRI Scans
• Study documentation
• Pharmacovigilance
• Monitoring activities.
The gathered information have provided updated information on all the centres involved in the study and are essential to identify the main issues to be solved to increase the effectiveness of the study and to ensure patients’ safety and high quality of collected data.
