SBER IRB GCP Training Requirement
GCP training is required for all researchers involved in the conduct, management or oversight of clinical trial research.
The National Institutes of Health (NIH) policy on Good Clinical Practice (GCP) training took effect January 1, 2017. As a result, GCP training will be required for all researchers involved in the conduct, management or oversight of clinical trial research. The NIH also expanded the definition of a clinical trial. A clinical trial is defined by NIH as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or social behavioral outcomes. GCP training is required for all research that meets this definition, regardless of funding source.