Observational influenza vaccine active surveillance study: A Phase IV Prospective Multi-Centre Cohort Study to Evaluate the Reactogenicity of bioCSL’s influenza virus vaccine (2015/2016 formulation) (CSLCT-SAF-15-07)

ENCePP Code of conduct

No

Data sources

• Data sources (types):
  Electronic healthcare records (EHR)

  Other
• Data sources (types), other:
  Data collection will utilise a mix of investigator site data entry and participant (or parent/guardian) self-reported data entry into a web-accessed electronic database meeting appropriate observational research, regulatory and data protection standards.

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