VIMKUNYA® Pregnancy registry: An Observational Prospective Study of the Safety of VIMKUNYA® Vaccine Exposure in Pregnant Women and their Offspring

ENCePP Code of conduct

Yes

Data sources

• Data source(s), other:
  Primary data collection, electronic patient reported outcomes (questionnaires)
• Data sources (types):
  Other

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

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

Data characterisation

• Data characterisation conducted:
  Yes
• Data characterisation moment:
  after data extraction

  after creation of study variables
• Data characterisation details:
  Data characterization and quality review activities are conducted periodically throughout the study to assess data completeness, consistency, plausibility, and fitness for purpose.; Reviews include assessment of enrolled pregnancies, availability of exposure information, completeness of maternal, pregnancy, and infant outcome data, and evaluation of loss-to-follow-up and missing data patterns. Data are reviewed for conformance with study specifications, including expected formats and permissible values.; Logical consistency checks assess relationships between key data elements, including chronology of exposure, pregnancy, delivery, and infant follow-up, and consistency between linked maternal and infant records. Plausibility assessments evaluate key variables for unexpected, implausible, or inconsistent values. Pharmacovigilance personnel also perform case-level reviews and follow up on missing or inconsistent data when appropriate.