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Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project

Lookup NU author(s): Dr Jonathan Richardson, Dr Kenneth Hodson, Dr Laura YatesORCiD



This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0).


© 2023, The Author(s).Introduction and Objective: The risks and benefits of medication use in pregnancy are typically established through post-marketing observational studies. As there is currently no standardised or systematic approach to the post-marketing assessment of medication safety in pregnancy, data generated through pregnancy pharmacovigilance (PregPV) research can be heterogenous and difficult to interpret. The aim of this article is to describe the development of a reference framework of core data elements (CDEs) for collection in primary source PregPV studies that can be used to standardise data collection procedures and, thereby, improve data harmonisation and evidence synthesis capabilities. Methods: This CDE reference framework was developed within the Innovative Medicines Initiative (IMI) ConcePTION project by experts in pharmacovigilance, pharmacoepidemiology, medical statistics, risk–benefit communication, clinical teratology, reproductive toxicology, genetics, obstetrics, paediatrics, and child psychology. The framework was produced through a scoping review of data collection systems used by established PregPV datasets, followed by extensive discussion and debate around the value, definition, and derivation of each data item identified from these systems. Results: The finalised listing of CDEs comprises 98 individual data elements, arranged into 14 tables of related fields. These data elements are openly available on the European Network of Teratology Information Services (ENTIS) website ( Discussion: With this set of recommendations, we aim to standardise PregPV primary source data collection processes to improve the speed at which high-quality evidence-based statements can be provided about the safety of medication use in pregnancy.

Publication metadata

Author(s): Richardson JL, Moore A, Bromley RL, Stellfeld M, Geissbuhler Y, Bluett-Duncan M, Winterfeld U, Favre G, Alexe A, Oliver AM, van Rijt-Weetink YRJ, Hodson KK, Rezaallah B, van Puijenbroek EP, Lewis DJ, Yates LM

Publication type: Article

Publication status: Published

Journal: Drug Safety

Year: 2023

Volume: 46

Pages: 479-491

Online publication date: 28/03/2023

Acceptance date: 06/03/2023

Date deposited: 12/04/2023

ISSN (print): 0114-5916

ISSN (electronic): 1179-1942

Publisher: Springer


DOI: 10.1007/s40264-023-01291-7

PubMed id: 36976447


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