Clinical project management: dalla progettazione al monitoraggio di un trial clinico.

The need that validity, ethic and scientific value occur in the conduction of a clinical trial has severely increased the number of ethical and legal requirements in the last decades. For this reason, the introduction of Good Clinical Practice (GCP) in 1982, has been followed by a big number of decrees in Italy, as well as in other Countries, making regulatory complexity in clinical research even greater. At the same time techniques and methodologies to conduct clinical trials have highly improved, reaching a common target for pharmaceutical companies, regulatory authorities and researchers. For all these reasons clinical research has become a complex field. In order to have a good management of clinical trials, a lot of research units have expressed the need to introduce in their research staff specialists with a scientific background, a good regulatory knowledge and project management skills to coordinate the team and the activities of a clinical trial. This specialist is the 'clinical project manager'. The aim of this PhD was: 1 - to manage, with the role of clinical project manager, clinical studies conducted by the Section of Endocrinology, Diabetology and Metabolism of Medicine Department of Verona University; 2 - to develop an operating system to plan and manage clinical trials; 3- to submit a questionnaire to the investigators met during the PhD, in order to understand their opinion about the utility of a clinical project manager in a research team and to suppose future development of this professional figure.