Abstracts of lectures

Abstract

The 2 principles of GCP are Ethics, as protection of human rights, and Science, as integrity and reproducibility of data produced from clinical trials. GCP responsibilities are shared among sponsor, monitor and investigator: methodology of clinical trial means the actuation by all the above actors of those behaviors that grant data reliability, worldwide regulatory acceptance and public credibility. Performance in routine clinical practice should not be confused with performance in clinical trials: the adopted methodologies are different except for the ultimate attention to the patient’s well-being. But while in the routine clinical practice the physician follows his best discretional medical behaviour, in clinical trials the investigator is called to follow a number of rules and procedures, to ensure proper documentation, to respect established timelines, to maintain written records, to accept the need for periodic monitoring and auditing. On the other side, the sponsor and the monitor must work with the investigator in order to ensure that each single produced data is reliable, accurate and adequately collected and analyzed. All above and much more can be synthesized as the methodology of clinical trial. This methodology is now a new branch of the science, the branch of Clinical Research.