Patient Registry

Patient Registry

An organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure and that serves one or more predetermined scientific, clinical, or policy purpose. Registries are generally defined either by diagnosis of a disease (disease registry) or usage of a drug, device, or other treatment (exposure registry) (source – Framework for FDA’s Real-World Evidence Program)