Observational influenza vaccine active surveillance study: A Phase IV Prospective Multi-Centre Cohort Study to Evaluate the Reactogenicity of bioCSL’s influenza virus vaccine (CSLCT-SAF-14-05)

ENCePP Code of conduct

No

ENCePP Seal

Signed checklist for study protocols

CSLCT-SAF-14-05_PASS protocol_4-AUG-14_Annex 2 ENCePP checklist

Data sources

• Data sources (types):
  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