Post-Authorization Active Surveillance Safety Study Using Secondary Data to Monitor Real-World Safety of Spikevax in Europe (COVID-19)

ENCePP Code of conduct

No

Data sources

• Data source(s):
  Clinical Practice Research Datalink

  Danish registries (access/analysis)

  The Information System for Research in Primary Care (SIDIAP)

  Norwegian Health Registers
• Data source(s), other:
  Other linked Norwegian Registries Norway, NorPD
• Data sources (types):
  Administrative healthcare records (e.g., claims)

  Other
• Data sources (types), other:
  Exposure registry, Routinely collected data on births, GP visits, hospital visits, vaccines, medicines, births, deaths, migrations.

Use of a Common Data Model (CDM)

• CDM mapping:
  Yes

CDM Mappings

• CDM name:
  ConcepTION CDM
• CDM website:
  https://www.imi-conception.eu/
• CDM release frequency:
  6 months

Data quality specifications

• Check conformance:
  Yes
• Check completeness:
  Yes
• Check stability:
  Yes
• Check logical consistency:
  Yes

Data characterisation

• Data characterisation conducted:
  Not applicable