EMA released the “Data Quality Framework for EU medicines regulation: application to Real-World Data”, establishing the principles and definitions under the scope of datasets used in medicine regulatory use cases.
This document describes the Real-World Data (RWD) specific recommendations as derived from the European Medicines Regulatory Network (EMRN) Data Quality Framework (DQF) for EU Medicines regulation endorsed by the Committee for Medicinal Products for Human Use (CHMP) (1) (hereafter referred to as EMRN DQF).
The EMRN DQF sets out the principles, concepts, and definitions as intended to be applied widely across datasets used in medicine regulatory use cases. It also provides examples and in-depth clarifications on the developed framework elements for characterising, assessing, and assuring Data Quality (DQ) in the regulatory context. It is therefore recommended to use the EMRN DQF as a companion document when reading this document.
Unless otherwise specified, the definitions provided in the EMRN DQF also apply to this document.
The application of the EMRN DQF to RWD (hereafter referred to as RW-DQF) sets out the specificities of RWD and enable regulators to evaluate the quality of data underpinning Real-World Evidence (RWE) as used in the regulatory assessment. It also provides guidance on the relevance assessment of such data, as well as data reliability assessment to a research question based on DQ metrics and evidence of systems and processes underpinning data.
These parts provide actionable and focused recommendations for assessing DQ of RWD, with the goal of supporting both the regulatory submission and assessment process and ultimately facilitate the use of RWE for regulatory purposes