Pregnancy Registry to collect Long-Term Safety Data from Women treated with HyQvia

ENCePP Code of conduct

No

Data sources

• Data sources (types):
  Other
• Data sources (types), other:
  Source data for this study comprise the following: hospital records, medical records, clinical and office charts, laboratory notes, memoranda, evaluation checklists, outcomes reported by subjects, recorded data from automated instruments, subject files, and records kept at the laboratories, and at medico-technical departments involved in the study.

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