Clinical Trial Agreement (CTA) – FACTS
A Clinical Trial is defined by the FACTS Office as a research study where the objective is either the testing of drugs, devices, diagnostics, treatments, interventions or preventive measure. This includes testing for an unapproved indication or Data collection to increase knowledge that would lead to enhanced safety and efficacy of a drug or device. The study must involve contact with humans, inclusive of medical record reviews. The source of funding or support must be a for-profit entity.