The NUM Study Network functions through a multi-layered, interactive system of governance and implementation. Its central coordination is supported by a robust governance structure, including:
These bodies provide strategic guidance, operational support, and an international perspective.
The NUM Study Network is actively rolling out specialized networks across study centers. These are referred to as “specialty networks”:
These networks are designed to build domain-specific expertise and streamline collaborative research across Germany.
The NUM Study Network is structured into several coordinated work packages (WPs), each of which contribute to the overall mission of improving clinical research infrastructure and collaboration across Germany.
WP1 lays the foundation for the governance, coordination, and strategic development of the NUM Study Network. It plays a central role in managing the overarching structures of the network and aligning the collaboration across specialty networks.
During the pilot phase (07/2024-06/2025), WP1 focused on establishing the NUM Study Network’s key governance bodies, including the Steering Committee and the Forum, which were introduced as interim structures to guide the network's strategic direction. This included defining terms of reference, organizing and facilitating meetings, and shaping a shared vision for a cross-disciplinary, future-ready research infrastructure. The goal was to design ideal workflows and identify the components necessary to support this vision, both existing and missing. Key efforts also included the integration of patient representatives into decision-making processes, as well as strategies to streamline contracts and improve communication across the network.
During the implementation phase (07/2025-06/2030), WP1 expands on these foundations by providing centralized project management for the NUM SN and supporting harmonization across participating specialty networks. The governance structures will be further developed and maintained in collaboration with NUM and the project management unit. WP1 also facilitates the integration of new national and international partners, including European research networks (e.g., ECRIN, BE READY NOW, European Vaccine Hub) and national research consortia. As external communication becomes increasingly important, suitable external study projects are identified, supported, and promoted through the NUM Study Network infrastructure.
The continuous evolution of the NUM Study Network is supported through regular plenary meetings, webinars, and workshops that help refine performance indicators, network processes, and training materials. In addition, WP1 oversees the development of standard templates for study protocols and contracts, ensures a harmonized framework for collaboration across all network levels, and drives the implementation of quality and performance metrics to guide the NUM Study Network and its specialty networks.
WP1 ultimately ensures that the NUM Study Network remains transparent, adaptable, and strategically aligned – providing a robust platform for high-quality clinical and clinical-epidemiological research across Germany.
WP2 focuses on establishing a unified contact point for researchers interested in conducting studies within the NUM Study Network. This central access point ensures that study proposals are reviewed efficiently and guided through the appropriate support structures within the network.
During the pilot phase (07/2024–06/2025), WP2 designed a standardized intake process and established clear quality criteria for the initial evaluation of study proposals. These criteria covered formal, ethical, methodological, regulatory, and scientific aspects essential to provide rapid and high-quality study support. Additionally, processes for forwarding inquiries to relevant internal and external NUM Study Network structures were conceptualized.
During the implementation phase (07/2025–06/2030), these structures are implemented and expanded. The intake office now actively supports interested researchers and refines its evaluation standards to address a broader range of study types and funding schemes. Coordination with both internal and external NUM Study Network stakeholders continues to ensure seamless support and alignment with regulatory and infrastructural requirements.
WP2 strengthens the NUM Study Network's ability to serve as an efficient, quality-driven research network by facilitating the initiation of studies and fostering collaboration among stakeholders across institutional and disciplinary boundaries.
WP3 focuses on identifying and developing key digital components essential for the efficient and transparent operation of the NUM Study Network. These capabilities go beyond what current software platforms offer and are vital for managing multi-stakeholder clinical studies across the network.
In the pilot phase (07/2025–06/2030), WP3 laid the groundwork by conducting market analyses of existing tools and defining future software needs. This included planning a modular digital ecosystem to support study coordination, communication between study sites and sponsors, and the tracking of anonymized progress, quality, and performance metrics. WP3 also initiated the further development of tools like eTIC (for creating consent documents) and expanded functionalities within the NUM Clinical Epidemiology and Study Platform (NUKLEUS) platform, such as visit-based metadata capture and real-time reporting.
Building on this foundation, the implementation phase (07/2025–2030) focuses on implementing an integrated NUM Study Portal within the NUM Hub. This portal will serve as a central digital entry point for all stakeholders involved in studies within the NUM Study Network.
Key developments include:
WP3 ensures that the NUM Study Network is supported by a robust, scalable, and user-friendly digital infrastructure that enhances collaboration, efficiency, and transparency across the entire clinical research network.
WP4 focuses on the development, implementation, and continuous enhancement of a digital recruitment platform that supports the identification of eligible study participants across the NUM Study Network. This tool significantly improves the efficiency of screening processes and feasibility assessments.
During the pilot phase (07/2024–06/2025), WP4 developed a foundational framework for patient prescreening and matching based on formalized inclusion and exclusion criteria. These criteria are evaluated interactively or automatically through a Query Module that runs against clinical data repositories within the Data Integration Centers (DIZ). Potential candidates are then forwarded via a Notification Module to responsible investigators for review and recruitment. The approach builds on prior work from the MIRACUM consortium and the CODEX+ project, using OMOP-based data storage implemented at multiple German sites.
During the implementation phase (07/2025–06/2030), the platform will be further developed and operationalized at a broader scale to support all NUM Study Network sites. This includes both technical and organizational improvements to enhance system usability and recruitment efficiency across different study types and specialty networks. The system is continuously monitored and refined based on user feedback and performance data.
Key activities include:
WP4 helps position the NUM Study Network as a digitally enabled, patient-centered research network – accelerating study feasibility, improving recruitment workflows, and enabling high-quality clinical and clinical-epidemiological research across Germany.
WP5 focuses on the structured development and integration of clinical sites into the NUM Study Network. It ensures that all participating locations are equipped, connected, and prepared to contribute actively to high-quality, multi-center clinical and clinical-epidemiological research.
During the pilot phase (07/2024–06/2025), WP5 established governance structures for the Specialty Network Infectious Diseases, including a steering committee, a forum, and internal coordination. These structures will also serve as the prototype for future specialty networks within the NUM Study Network. The network's vision and development goals were refined through structured dialogue within advisory bodies. Additionally, communication strategies were launched, and potential user groups were actively engaged to strengthen the network's visibility and relevance.
During the implementation phase (07/2025–06/2030), WP5 supports the broader rollout of the NUM Study Network to clinical sites nationwide.
Sites receive phased start-up funding and must meet defined readiness criteria. These criteria include participation in feasibility assessments, availability of a functioning Data Integration Center (DIZ), and willingness to adopt shared contract templates and compensation models. Through three planned onboarding waves, up to 35 sites will have joined the NUM Study Network across multiple specialty networks by 2028.
Key activities include:
By strengthening site infrastructure and coordination, WP5 ensures that the NUM Study Network functions as a cohesive, scalable, and high-performing national research network.
