The European Medicines Agency (EMA) and the European Medicines Regulatory Network established a coordination centre to provide timely and reliable evidence on the use, safety and effectiveness of medicines for human use, including vaccines, from real world healthcare databases across the European Union (EU). This capability is called the Data Analysis and Real World Interrogation Network (DARWIN EU®).

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In the Execution Phase the Data Partners execute the Study Package against the OMOP CDM and review the aggregated results. This includes applying quality checks on the study results and a data privacy check to assure that only aggregated data is shared compliant to their local governance procedures. 

Execution Iterations

The data partners locally execute the analytics against the OMOP-CDM and review and approve the aggregated results before returning them to the Coordination Centre. Sometimes multiple execution iterations are performed, and additional fine tuning of the code base is needed. A service desk is available during the study execution for support.

Quality Control

The study results of all data sources are checked after which they are made available to the team in the Digital Research Environment and the Dissemination Phase can start. All results are locked and timestamped for reproducibility and transparency.