VALIDATION STUDY PROTOCOL (OP0007) FOR THE EUROPEAN NON-INTERVENTIONAL POST- AUTHORIZATION SAFETY STUDY RELATED TO SERIOUS CARDIOVASCULAR EVENTS OF MYOCARDIAL INFARCTION AND STROKE AND ALL-CAUSE MORTALITY FOR ROMOSOZUMAB BY THE EU-ADR ALLIANCE (OP0004) AND EUROPEAN NON-INTERVENTIONAL POST-AUTHORIZATION SAFETY STUDY RELATED TO SERIOUS INFECTIONS FOR ROMOSOZUMAB BY THE EU-ADR ALLIANCE (OP0006)

ENCePP Code of conduct

No

Data sources

• Data source(s):
  Integrated Primary Care Information (IPCI)

  The Information System for Research in Primary Care (SIDIAP)

  German Pharmacoepidemiological Research Database
• Data sources (types):
  Administrative healthcare records (e.g., claims)

  Electronic healthcare records (EHR)

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

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

Data characterisation

• Data characterisation conducted:
  No