Establish an EU catalogue with metadata of data sources and studies

Study identification

• EU PAS number:
  EUPAS104093
• Study ID:
  104094
• Official title and acronym:
  Establish an EU catalogue with metadata of data sources and studies
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  France

  Germany

  Netherlands

  Portugal
• Study description:
  The identification of appropriate data sources to answer specific research questions and to assess the suitability of these data sources for a study might be challenging. To support the identification of suitable data sources, the HMA-EMA joint Big Data Task Force recommended “to promote data discoverability through the identification of metadata” as part of its Recommendation III, which is reflected in the Big Data Steering Group work plan. Metadata are descriptive data that characterise other data to create a better understanding of their meaning and to achieve greater reliability and quality when using data for a specific purpose. The Agency is developing an electronic catalogue that will provide metadata for data sources and studies targeted for release in late 2023. The Agency started collecting metadata of data sources in 2022 and an initial set of 24 data sources was captured (EU PAS EUPAS49303). To further accommodate this process, the Agency started a process with IQVIA to collect a defined set of metadata for 50 data sources in 2023 and a process to verify and refine the defined set of metadata information for 1,270 finalised studies migrated from EU PAS Register® to the new studies catalogue. Main objective of this study: • The overall objective is to establish an EU catalogue of data sources and studies, characterised by a common set of metadata and data quality measurements. Specific objectives are: • To verify and refine the defined set of metadata for finalised studies migrated from the current EU PAS Register® to the new catalogue of studies. • To collaborate with data holders in order to collect the defined set of metadata for data sources migrated from the ENCePP resource database to the new data sources catalogue and also other data sources. This includes quality checking of the information received from data holders.
• Study status:
  Finalised

Research institutions and networks

Institutions

IQVIA NL, Real-World-Evidence

Netherlands

Study timelines

Date when funding contract was signed

Planned:05/12/2022

Actual:05/12/2022

Study start date

Planned:01/03/2023

Actual:22/03/2023

Date of final study report

Planned:15/12/2023

Actual:01/07/2024

Sources of funding

EU institutional research programme

More details on funding

EMA

Regulatory

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