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

Study type

• Study topic:
  Other
• Study topic, other:
  Disease/Epidemiology study
• Study type:
  Not applicable
• Scope of the study:
  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:
  Propose a methodology to grow the EU catalogue of real-world data sources in a sustainable manner and catalogue an initial set of 24 data sources.
• Data collection methods:
  Combined primary and secondary data collection

Population studied

• Short description of the study population:
  N/A
• Age groups:
  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)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  To establish an EU catalogue of sources of real-world data, characterised by a common set of metadata and data quality measurements.
• Data analysis plan:
  Not applicable