Impact of EU label changes and revised pregnancy prevention programme for medicinal products containing valproate: utilisation and prescribing trends

ENCePP Code of conduct

No

ENCePP Seal

This study has been awarded the ENCePP seal

Conflicts of interest of investigators

DoIForm_v1.6 valproate klungel

Composition of steering group and observers

Information DoI and steering group EUPAS31001

Signed code of conduct

2019-0058_Annex 3_Compliance declaration_completed + handtekening

Signed code of conduct checklist

2019-0058_Annex 2_CoC Checklist_completed + handtekening

Signed checklist for study protocols

2019-0058_ENCePPChecklist_Valproates_22AUG2019 FINAL

Data sources

• Data source(s):
  Clinical Practice Research Datalink

  Danish registries (access/analysis)

  PHARMO Data Network

  Base de Datos para la Investigación Farmacoepidemiológica en el Ámbito Público (Pharmacoepidemiological Research Database for Public Health Systems)

  ARS Toscana
• Data sources (types):
  Administrative data (e.g. claims)

  Disease registry

  Drug dispensing/prescription data

  Electronic healthcare records (EHR)

Use of a Common Data Model (CDM)

• CDM mapping:
  Yes

CDM Mappings

• CDM name:
  ConcepTION CDM
• CDM website:
  https://www.imi-conception.eu/
• CDM release frequency:
  6 months

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 extract-transform-load to a common data model

  after creation of study variables"