EMA publishes Data Quality Framework for Real World Data

The EMA has published the Data Quality Framework for EU medicines regulation: application to Real-World Data. The intention of the Framework is to establish a consistent, standardised approach to ensuring the quality of data collected within the context of real-world evidence. The framework provides a structured set of terminology, definitions, principles and guidelines applicable to various data sources that are to be applied when collecting real world evidence within the context of fulfilment of regulatory obligations related to medicinal products. The Framework also provided examples and in-depth clarification concerning the elements of frameworks for characterising, assessing, and assuring Data Quality and reassuring patients and healthcare professionals.