Training course: "The role of the data manager..."

from June 06 2011 to June 07 2011

Independent clinical research is an increasingly important element in the broader context of clinical research in general.
Even in the world of "investigator oriented" clinical research, in any case, exploring new avenues is no longer allowed unless within a protocol, written and conducted in accordance with all laws and regulations that have been issued with the aim of guaranteeing patient safety and the validity of the results. Consolidating the role of “non-profit” associations and of Collaborative Groups as efficient and modern organizations is therefore crucial in order that they may contribute to the intellectual independence of scientific research.

Otherwise, there is a risk that the capacity to design and conduct clinical trials, will be lost, leaving everything in the hands of the Industry. In this respect the role of the data manager has come into its own over the last few years. A professional who coordinates clinical trials and represents a reference point for both the team conducting the clinical trial (doctors, nurses, biologists, pharmacists, statisticians...) and for local and external regulatory authorities (Hospital Management, Ethics Committees, Pharmaceutical companies, CROs, monitors, data centres, cooperative groups). In order to promote and improve the culture of Data Management within our healthcare system, we have organized a training course on "The role of Data Managers within independent clinical research", aimed at anyone working in the field.

The idea for this came from the synergy between two bodies which, in different ways, work in this area: the non-profit GIMEMA Foundation (Gruppo Italiano Malattie EMatologiche dell'Adulto) which for many years has been committed to promoting independent research protocols in Hematology, and the GIDM (Gruppo Italiano Data Manager - Italian Data Managers Group) which is involved in promoting the role of Data Managers and their training.