Analysis of pregnancy pharmacovigilance data in spontaneous reports, and literature, (Individual Case Safety Reports originating from published case series, non-interventional studies and patient support programmes); demonstration study 2.5.1 of the ConcePTION project

ENCePP Code of conduct

No

Data sources

• Data sources (types):
  Spontaneous reports of suspected adverse drug reactions

  Other
• Data sources (types), other:
  Prospective patient-based data collection

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