TECHNICAL COMMITTEE

This Technical Committee supports the scientific commissions in the evaluation of proposals. The Technical Committee is composed of experts in different areas, and thus can be extremely helpful:

• Patrizia Tosi (Rimini) and Renato Zambello (Padova) for ethical committee considerations;

• Paola Demartini (Torino) for budget issues;

• Simona Barbato (Bologna) for study documentation and study coordination;

• Alfonso Piciocchi (Roma) and Ajsi Kanapari (Bologna) for statistical matters and CRF.

When an Italian investigator wants to propose a study to the Working Group and include all the Italian sites represented by it (be it a retrospective or prospective study), a study synopsis, a budget (if available, or at least some initial agreements with sponsors) and this form should be sent to both the relevant scientific commission’s coordinators and to the technical committee (datacenter@emnresearch.it).

After having expressed their comments, the Technical Committee sends a summary to the coordinators of the relevant commission. In this way, the coordinators will evaluate the proposal from a scientific/medical point of view, while the Technical Committee will focus more on technical issues and the actual feasibility of the proposal.

Afterwards, the coordinators will have a more thorough picture of the proposal, whether it can be pursued and will make a final decision. If they accept the proposal, the whole Working Group will be informed of this, and the project can start as a project under the Working Group of the EMN Italy.

When the proposing investigators request the assistance of EMN Italy in order to appropriately move forward with a proposal (as specified in the proposal form, for instance for the study activation, study management, statistical analysis, etc.), the EMN Trial Office team will closely collaborate with them. The aim is to prepare a well structured and sensible proposal for sponsors, also with an appropriate statistical analysis.

The proceudre for the proposals from the commissions and the specific steps are summarized here.