This guideline addresses the methodological, regulatory and operational aspects involved in using registry-based studies to support regulatory decision-making.
A patient registry is an organised system that collects uniform data over time on patients who are diagnosed with a particular disease or condition, or who receive particular medicines. A registry-based study is a clinical trial or a non-interventional study that investigates a research question using the data collection infrastructure or the patient population of one or several patient registries.
A Registry-based study is an investigation of a research question using the data collection infrastructure or patient population of one or several patient registries. A registry-based study is either a clinical trial or a non-interventional study as defined in Article 2 of Regulation (EU) No 536/2014.
A registry-based study may apply primary data collection in addition to secondary use of the existing data in the registry.
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.