Report describing the metadata model (variables) for data collection on pregnancy data sources, as basis for the catalogue collection of exposed pregnancies

Task 2.2: Catalogue of industry and publicly held data sources and handling processes (M1-16) (LAREB, ENTIS, NVS, Novo Nordisk, Pfizer, Sanofi, NUTH, UKZN, UMAN, AbbVie) in collaboration with WP7. Regulators, industry and teratology information databases and clinical disease-based registries contain a mixture of prospectively reported pregnancy exposures, retrospective case reports and paternal exposures (industry pregnancy registries and PV databases, UK Epilepsy Pregnancy Registry, adverse event reporting systems, Teratology Information Service registries or databases, non-pregnancy disease registries). In addition, case reports of exposed pregnancies data are collected incidentally as secondary outcomes through various other sources or reported in the published literature (randomised controlled trials, research cohorts and case series, other). Using the WP1 literature mining tool, and through the partner and stakeholder network we will identify data sources with reports of pregnancies. We will create