Evaluating Data Quality by Proxy: Can We Evaluate All Dimensions of the European Medicines Agency Data Quality Framework for Registry‐Based Post‐Authorization Safety Studies?

We propose a set of consistent definitions of information requirements and quantitative DQIs that complement existing tools that can be used for evaluating DQ throughout the registry-based PASS lifecycle. If DQIs cannot be evaluated during the preparation of the PASS protocol, uncertainties and their potential impact on the study results need to be acknowledged in the relevant study documents. Additionally, scenario mapping for the removal or replacement of registries with insufficient DQ after PASS initiation is needed.