This guideline addresses the methodological, regulatory and operational aspects involved in using registry-based studies to support regulatory decision-making.

It aims to help with defining study populations and designing study protocols. It provides guidance on data collection, data quality management and data analysis to achieve higher quality evidence.

The guideline focuses on studies involving disease registries or condition registries to evaluate the benefit-risk of medicines prescribed to or consumed by patients. It explains the methodological differences between these types of studies and registries.

It also contains an annex with good practices in the establishment and management of patient registries and their use for other possible regulatory purposes.

Keywords: Patient registry, real world evidence, real word data, registry-based study, feasibility analysis

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