An Observational Post-Authorization Safety Study to Assess the Safety of Ad26.COV2.S Using Health Insurance Databases in the United States

ENCePP Code of conduct

Yes

Data sources

• Data source(s), other:
  CVS Health Clinical Trial Services United States ; HealthCore United States; Humana United States; Optum United States
• Data sources (types):
  Administrative healthcare records (e.g., claims)

Use of a Common Data Model (CDM)

• CDM mapping:
  Yes

CDM Mappings

• CDM name:
  Sentinel
• CDM website:
  https://www.sentinelinitiative.org/methods-Data-tools/sentinel-common-Data-model

Data quality specifications

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

Data characterisation

• Data characterisation conducted:
  Yes