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

ABSTRACT:

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 Initiativ

SUBMITTER: Richardson JL 

PROVIDER: S-EPMC10164024 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature