The CTC was established by Decree No. 308 dated 24 April 2018 and subsequently amended with Decree No. 602 dated 06 August 2018. The components of both the CTC and External Units is shown in Figure 8. The CTC performs the following functions:

  • Coordinates and monitors the functional activities regarding the management of clinical trials within the IFO, acting as a qualified reference point;
  • Guarantees greater control of the clinical trials to the Scientific Directions of Regina Elena and San Gallicano Institutes and IFOs Medical Office;
  • Particular supports in the spontaneous non-profit research;
  • Interacts with the Departments involved in experimental research activities, coordinating the activities of the experiments aimed at:
    1. Providing administrative, managerial, methodological and statistical services to researchers for the conception, design, planning, start-up phase, conduction, analysis and reporting of clinical studies so that these activities are carried out in compliance with the Good Clinical Practice (GCP) and the protocols;
    2. Supporting the management of authorization procedures as well as the conduction and financial reports of clinical studies;
    3. Promoting, in profit and non-profit research, the professional development of all participating researchers in terms of compliance with GCPs and regulatory aspects;
    4. Guaranteeing quality control of studies (experimental and observational studies) with profit and non-profit study promoters;
    5. Supporting monitoring of information regarding the feasibility of studies in terms of potentially enrolled patients;
    6. Increasing the synergistic collaboration between researchers involved in the studies;
    7. Evaluating the experiments proposed by researchers at IFO, for which IFO takes on the role of Promoter, and monitors the progress of the approved studies;
    8. Identifying areas of great strategic interest for the Institute and propose initiatives necessary for promoting clinical trial projects in these areas