Registry Study

Registry Study

EU: EMA Use of Patient Disease Registries for Regulatory Purposes – The data collected in a registry may be used for the purpose of a specific study, i.e. a detailed investigation of a research question or hypothesis. The difference between a registry and a registry-based study (a registry study) must be well understood to avoid confusion in concepts and methods. It is acknowledged that regulators have sometimes requested marketing authorisation holders (MAHs) to establish a registry, although the objective was to perform a post-authorisation safety study (PASS) to monitor the safety of a product. Some existing guidance seems also to use the terms “registry” and “study” interchangeably (as per Section 3.3 of EMA – Discussion paper: Use of patient disease registries for regulatory purposes – methodological and operational considerations, Nov 2018).

The main differences between a registry and a registry study are summarised in Table 1: