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 Initiation Phase the contractual agreements are setup with the selected Data Partners, the Study Team is formed, and the Conflicts of Interest procedure is applied.

Contractual Agreements

Upon green light to conduct a study, the Coordination Centre is responsible for the contractual agreement and onboarding of Data Partners in the study. A standardised work order is initiated by the DARWIN EU® CC which indicates the agreed timelines and the budget of the study. Each data partner will sign a standard work order agreement which specifies their activities, budget, and timelines. 

Team Formation

The level of involvement of a study team will strongly depend on the Study Type, i.e., simple off the shelf studies may be run near automatically with a fast review step by a small team. For more complex studies a larger team may be proposed by Study Operations. This team consist of data scientists, epidemiologists, and clinical domain experts who are responsible for Evidence Generation and Evidence Synthesis. The team is completed with Data Stewards from the participating Data Partners who will work in a secured collaboration space.

Documentation and assessment of Conflicts of Interest

Potential investigators to be assigned to a DARWIN EU® study shall be requested to declare any existing direct or indirect interests in a pharmaceutical company. These terms are further defined in the EMA Policy 0044. More details on The DARWIN EU Conflict of Interest Procedure can be found in our Principles & Policies section. EMA will review the submitted forms and will approve the team composition.