The Working Group has as its main objectives to promote the research quality and work together with the most important research centers to define and share aspects and importance criteria for the excellence centers quality, assuming that the role of the investigator in the research center and the creation of hospital facilities to support the clinical trials are in strong development, as well as the interaction with patient associations.
A White Paper has been developed by the Working Group. The document outlines the agreed definition of a Clinical Trial Center (CTC) and is aimed to provide guidelines to Healthcare Structures who’d wish to create an infrastructure (CTC) whose primary role would be to guarantee the oversight of clinical trials within the Healthcare Structure, also touching the main elements that AICRO would recommend to find at these infrastructures.
Currently, the group develops its work through a synergetic and cooperative project between AICRO and a large number of prominent members from the world of clinical research (professional associations, research centres, IRCCS, A.O.U.)
The 5 working subgroups are developed on the following topics:
1) Source Documents;
2) New European Regulation;
3) Collaborations with Associations;
4) CTC and professional figures;
5) DCT Management.
Presence and activities of clinical research coordinators at Italian Health Care
