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Bigpicture partners sign pioneering Data Sharing Agreement

25 July, 2024

Bigpicture is pleased to announce the successful signing of the new Data Sharing Agreement (DSA) by all beneficiaries, marking a significant milestone in the project. The DSA aims to facilitate the secure and responsible transfer of personal data among beneficiaries under the General Data Protection Regulation (GDPR) for research use, as defined in the Consortium Agreement.


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The DSA is a comprehensive framework designed to ensure that data sharing within the Bigpicture project is conducted safely and responsibly. Jan-Willem Boiten, co-lead of Work Package 5 (WP5), and senior program manager at Lygature, explains, "The DSA sets out all necessary safeguards and clearly defines the roles and responsibilities related to data sharing. It's crucial that these agreements are clear and all risks are covered.” 

Crafting a DSA that aligns all 44 partners in the project is a complex, thorough process. Jan-Willem: “The DSA forces you to delve into the specifics, clarifying data requests and permissions”, says Jan Willem. He continues: “You need to start with a thorough analysis—understanding data flows and responsibilities before moving to legal aspects.”

The DSA sets out all necessary safeguards and clearly defines the roles and responsibilities related to data sharing.

Clear framework for data contribution and usage

The agreement covers all aspects data contribution and usage between the project partners, covering both the project use cases as well as internal partner research outside the scope of Bigpicture. It outlines the roles and responsibilities of data contributors, data users , and data hosting parties responsible for maintenance of the central data repository, ensuring a regulated and well-defined approach for repository use. “I am happy that all partners were very involved and put a lot of effort in this agreement. Bigpicture also collaborates with other projects to standardize this process, making it easier for future projects."

The crucial role of data security and clarity

The DSA is essential for Bigpicture’s success, as it ensures that data rights and obligations are clearly defined. "No one will share data if their rights and responsibilities are not clear, especially when it comes to potentially sensitive personal data," says Jan-Willem. "Similarly, no one will use data if the licensing terms are unclear. Without the DSA, there would be no data sharing."

The next step in safe data sharing

"We don't take data handling lightly," assures Jan-Willem. With the DSA in place, the next steps involve a phased approach to involve more stakeholders. "We plan to include more data contributors, the so-called slide contributing third parties (SCTPs), who will not only contribute data but also receive data usage rights. Eventually, we aim to grant external users access, creating a sustainable repository beyond the project," explains Jan-Willem. "The current agreement is rooted in the consortium agreements, so we'll need to revisit concepts as the project evolves and external parties become involved."

Acknowledgements: This DSA was made possible by the collaborative efforts of all beneficiaries, but in particular Lygature, TimeLex, and Novartis. 

Portrait of Jan-Willen Boiten. Source: Portrait received from partner.
Bigpicture Webinar on the Data Sharing Agreement

Bigpicture has invited Jan-Willem to host a Bigpicture Webinar to provide more in-depth information on the DSA after the summer. Check our regular updates on LinkedIn and the website for details and upcoming registration.

About Jan-Willem Boiten

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Funding

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 945358. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation program and EFPIA. www.imi.europa.eu

  • Innovative Medicines Initiative
  • European Federation of Pharmaceutical Industries and Associations
  • European Union