International Active Surveillance Study: Native Estrogen Estetrol (E4) Safety Study (INAS-NEES)

ENCePP Code of conduct

No

Data sources

• Data source(s):
  Other data source
• Data source(s), other:
  Electronic patient-reported outcome questionnaires at baseline and four follow-up questionnaires at 6, 12, 18 and 24 months; electronic medical records
• Data sources (types):
  Death registry

  Electronic healthcare records (EHR)

  Non-interventional study

  Patient surveys

  Spontaneous reports of suspected adverse drug reactions

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 creation of study variables