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

Jonathan Luke Richardson Alan Moore Rebecca Louise BromleyMichael StellfeldYvonne Geissbühler Matthew Bluett-Duncan Ursula Winterfeld Guillaume Favre Amalia Alexe Alison M Oliver Yrea R J van Rijt-Weetink Kenneth K Hodson Bita Rezaallah Eugene P van Puijenbroek David John Lewis Laura M Yates

Published in: Drug safety (2023)

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.

Keyphrases

electronic health record
big data
preterm birth
data analysis
emergency department
adverse drug