Good Clinical Practice Refresher - Biomedical
Good Clinical Practice (GCP) is an international standard for trials involving human subjects. Compliance with this standard ensures the rights, safety, and well-being of trial subjects are protected and that the clinical trial data are credible. Yale University requires investigators and clinical trial site staff who are responsible for the conduct, management, and oversight clinical trials to be trained in Good Clinical Practice (GCP) and to participate in a GCP refresher course every three years. The Biomedical GCP Refresher session will focus on clinical trials where compliance with ICH GCP R2 is required and the applicability of pertinent regulations such as the Food and Drug Administration.