Establish an EU catalogue of sources of real-world data, characterised by a common set of metadata and data quality measurements

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49304
• EU PAS number:
  EUPAS49303
• Study ID:
  49304
• Official title and acronym:
  Establish an EU catalogue of sources of real-world data, characterised by a common set of metadata and data quality measurements
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Czechia

  Denmark

  Finland

  France

  Germany

  Italy

  Netherlands

  Norway

  Poland

  Slovakia

  Spain

  Sweden

  United Kingdom
• Study description:
  Europe is generating unprecedented amounts of person-level information contained in Electronic Medical Record (EMR) systems. This includes structured data in the form of diagnoses, medication, and laboratory test results. These EMR datasets are often siloed by country, language, region, hospital and even department, captured in a disease specific context, however, these data contain invaluable insights for regulatory purposes. Metadata is traditionally defined as “data about data”. It’s a set of data that describes and gives information on other data providing context about their purpose, location, key-variables, generation, format, and ownership of a dataset. Metadata help both researchers and study sponsors to identify datasets for conducting specific studies. Currently, publicly available metadata is limited, not coherent between different sources, and not defined with a regulatory purpose in mind. Therefore, the Agency is currently developing an EU catalogue of real-world data sources which will replace the existing ENCePP catalogue in late 2023. To accommodate this process, the Agency awarded IQVIA to propose a methodology to grow and maintain the catalogue in a sustainable manner, as well as to catalogue an initial set of 24 data sources in 2022. The overall objective is to establish an EU catalogue of sources of real-world data, characterised by a common set of metadata and data quality measurements.
• Study status:
  Finalised

Research institution and networks

Institutions

Real-World-Evidence, IQVIA NL

Netherlands

Multiple centres: 24 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 13/12/2021

Actual: 13/12/2021

Study start date

Planned: 01/07/2022

Actual: 01/07/2022

Date of final study report

Planned: 23/01/2023

Actual: 21/03/2023

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable