The guideline 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.

It 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.

EMA's Cross-Committee Task Force on Registries and the CHMP agreed the final guideline following a public consultation.