Post-Authorisation Active Surveillance Study of Myocarditis and Pericarditis Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine

ENCePP Code of conduct

No

Data sources

• Data source(s):
  Clinical Practice Research Datalink

  The Information System for Research in Primary Care (SIDIAP)

  PHARMO Data Network

  ARS Toscana

  Pedianet

  EpiChron Cohort

  Norwegian Health Registers
• Data sources (types):
  Administrative healthcare records (e.g., claims)

  Disease registry

  Electronic healthcare records (EHR)

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:
  No