Guideline on registry-based studies - Scientific guideline

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

Current effective version

Guideline on registry-based studies

AdoptedReference Number: EMA/426390/2021Summary:

Adopted guideline

Document history

Guideline on registry-based studies

AdoptedReference Number: EMA/426390/2021Summary:

Adopted guideline

Guideline on registry-based studies

Consultation dates: 24/09/2020 to 31/12/2020Draft: consultation closedReference Number: EMA/502388/2020Summary:

The guideline was developed based on the comments received on the discussion paper on ‘Methodological and operational considerations on the use of patient disease registries for regulatory purposes’, that went through a public consultation between November 2018 and June 2019, and a consultation of EMA Committees and Working parties.