A common data model for harmonization in the nordic pregnancy drug safety studies (Norpress)

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  • Jacqueline M. Cohen
  • Carolyn E. Cesta
  • Lars Kjerpeseth
  • Maarit K. Leinonen
  • Óskar Hálfdánarson
  • Øystein Karlstad
  • Pär Karlsson
  • Andersen, Morten
  • Kari Furu
  • Vidar Hjellvik

It is necessary to carry out large observational studies to generate robust evidence about the safety of drugs used during pregnancy. In the Nordic countries, nationwide population-based health registers that document all births and dispensed prescribed drugs are valuable resources for such studies. A common data model (CDM) is a data harmonization and structuring tool that enables a unified and streamlined analytic approach for studies including data from multiple countries or databases. We describe a CDM developed for the Nordic Pregnancy Drug Safety Studies (NorPreSS), including details on data sources and structure of the data tables. We also provide an overview of the advantages and disadvantages of the approach (e.g. sharing of data analysis programs versus extra initial work to create CDM datasets from raw data).

Original languageEnglish
JournalNorsk Epidemiologi
Volume29
Issue number1-2
Pages (from-to)117-123
ISSN0803-2491
DOIs
Publication statusPublished - 2021

Bibliographical note

Funding Information:
The study was partly supported by NordForsk Nordic Program on Health and Welfare (Nordic Pregnancy Drug Safety Studies, project No. 83539), by the Research Council of Norway (International Pregnancy Drug Safety Studies, project No. 273366) and by the Research Council of Norway through its Centres of Excellence funding scheme (project No. 262700).

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