Demonstration study 2.5.5 of the ConcePTION project; Validation of primary source pregnancy exposure and outcomes (pharmacovigilance data)

ENCePP Code of conduct

No

Data sources

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

  Other
• Data sources (types), other:
  Sub-study 2 will undertake child health and neurodevelopmental assessments conducted during clinical reviews to validate data provided by parents through remotely completed questionnaires. The study will recruit women with Fetal Valproate Spectrum Disorder, and in utero exposure to other antiepileptic drugs.

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