DPs that are part of the DARWIN EU® network will maintain a relationship with the CC, realised in two different ways:

1. DPs will be active study participants and co-author results. 

   DPs who are onboarded will be eligible to participate in studies undertaken in DARWIN EU®. This means that, after a feasibility assessment has been completed, they may be invited to studies and, if agreeing to participate, run centrally-developed code to return aggregated results to the CC for integration and reporting. However, DPs are more than data providers who are just running common analytics and returning results: they are the experts in their database and can contribute to all aspects of the study including design, quality control, and dissemination of results. We therefore believe that suitably experienced DPs should be able to opt-in for multiple roles in a study, including scientific and epidemiological expertise and report/publication development. This is also important for the necessary capacity building, so DARWIN EU® can scale up to facilitate the completion of studies in parallel in its operational phase. It is expected that participating DPs will co-author publications resulting from the corresponding studies.

2. DPs will receive DARWIN EU® training. 

   We will provide periodic training and workshops, in part offered via remote learning environments, so that DPs are aware of the latest best practice in data use and management, study development and methods and tools. Onboarded DPs will be expected to actively participate in a thriving DARWIN EU® community, which will allow exchange of experiences and opportunities for continuing improvement and growth.

What are the benefits for DARWIN EU® DPs?

1. Working for the benefit of the EMA and EMRN with the generation of real-world evidence critical for medicines regulation at the European level, for example on diseases, patient populations, and the use, safety and effectiveness of medicines, including vaccines, throughout the lifecycle of a medicinal product.
2. Supporting decision-making on the use, safety and effectiveness of medicines, from which a wide range of stakeholders will benefit, from patients and healthcare professionals through to health technology assessment bodies and the pharmaceutical industry.
3. Participation in high-impact publications derived from studies undertaken in DARWIN EU®.
4. Assurance of scientific independence, freedom to decline studies, respect for each institution’s own approval procedures.
5. Facilitated scientific collaboration, connections with peers and learnings by becoming part of a thriving academic/medical/regulatory network and community.
6. Increased external visibility for the DP’s data, expanding opportunities to participate in other studies, joint research projects and grant proposals beyond DARWIN EU®, helping the long-term sustainability of the DP. Boosted opportunities to participate in other international studies for larger regulatory impact, which will provide an invaluable resource to prepare for and respond to future healthcare crises and pandemics.
7. Improved interoperability and understanding of own data, enhancing data partners’ internal decision-making processes, with potential to propagate learnings inside institutions to enhance procedures and generally improve the underlying healthcare systems. Added possibilities for auditing/refining/visualising own data through open source tooling – understanding own data sets better, including integrative analyses, revealing the potential flaws for continued improvement.
8. Increased transparency of analyses and reproducibility, enabling studies to be easily ‘transposed’ to other data sources for multiplied impact (e.g., in publications).
9. Increased speed of performing studies, improved performance, accelerated research (months/years to weeks): allowing DPs to undertake more studies in less time, with less resources.
10. Access to a training platform on data standardisation, quality control, and analytics by the Coordination Centre.
11. Exposure to and collaborative experience with world-class experts in real-world evidence generation using the OMOP CDM.