mRNA-1273-P919: An Observational Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy

ENCePP Code of conduct

Yes

Data sources

• Data source(s), other:
  HealthCare Integrated Research Database (HIRD); American Community Survey (ACS)
• Data sources (types):
  Administrative healthcare records (e.g., claims)

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:
  Yes
• Data characterisation details:
  Data validation is planned to occur throughout the data management and analysis process. Data quality checks include, but are not limited to, programming checks by an individual who is not the main programmer for the study, internal dataset consistency, and checks to ensure that Protocol criteria were met.