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

ENCePP Seal

This study has been awarded the ENCePP seal

Conflicts of interest of investigators

ENCePP DoIForm_v1.6_EvP

Composition of steering group and observers

EUPAS38841_steering group

Signed code of conduct

ENCePPCoCAnnex3_DeclarationofcompliancewiththeENCePPCodeofConduct

Signed code of conduct checklist

EUPAS38841-38876

Signed checklist for study protocols

ENCePP Checklist for Study Protocols_YW

Data sources

• Data sources (types):
  Spontaneous reporting system

  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