Establish an EU catalogue with metadata of data sources and studies

Study type

• Study type:
  Not applicable
• Scope of the study:
  Drug utilisation

  Other
• If ‘Not applicable’, further details on the study type:
  EMA big data initiative, Metadata collection
• If ‘other’, further details on the scope of the study:
  EMA Big Data initiative

Population studied

• Short description of the study population:
  This project is not a study but rather part of the EMA Big Data initiative to establish an EU catalogue of real-world data sources. Any responses regarding “data” in this questionnaire refer to metadata (not individual-level data) for the purposes of this project.
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  1000000

Study design details

• Main study objective:
  EMA requires additional work related to the enrichment of data sources metadata following the migration of the current ENCePP resource database to the new catalogue. EMA has mapped the data fields between the ENCePP Resource Database and the new studies catalogue. IQVIA will provide support to the data sources for the completion of the spreadsheet, will quality check the file and provide feedback.
• Data analysis plan:
  Not applicable