User Roles, Onboarding Procedures & Access Governance in Cancer Image Europe

Data Holders (DHs) → entities that provide data for secondary use. These can include research institutes, biobanks, hospitals, public organizations, or pharmaceutical companies. Depending on their mode of participation, DHs can operate as:

• Federated Nodes, keeping their data locally, 
• Reference Nodes, transferring anonymized data to Cancer Image Europe's central nodes.

DHs operate in two distinct environments: the Research & Innovation Environment, in which existing datasets are made available through the Cancer Image Europe public catalogue, and the Real-World Data Environment, in which new datasets are generated for specific research studies. Depending on the data-sharing model, DHs must sign a Data Sharing Agreement (DSA) if they function as federated nodes or a Data Transfer Agreement (DTA) if they transfer data to Reference Nodes. To ensure standardization and interoperability, DHs must format clinical data and images according to the Common Data Model (CDM) and the EUCAIM Hyper-ontology, moreover compliance with GDPR and security regulations is mamdatory. Compliance is structured into three levels: TIer 1 → allows only dataset searching in the public catalogue, Tier 2 → enables remote queries, Tier 3 → grants full access for AI model training (see also section about  The Cancer Image Europe Data Federation).

To join Cancer Image Europe, a Data Holder must first submit an Expression of Interest (EoI), which is assessed by the Access Committee (AC) based on scientific quality and legal compliance. Upon approval, they must sign the appropriate regulatory agreement (DSA or DTA). If a DH operates as a Federated Node, they retain control over their data within their environment, ensuring anonymization and dataset quality while meeting minimum technical requirements. If they join as a Reference Node, they must transfer data centrally, use anonymization tools, and register datasets in the metadata catalogue following FAIR principles (see also section about FAIR Data).

 

Software Providers (SPs) → entities that can contribute to the platform by offering processing tools, services, and AI models for data analysis. To be integrated, software must meet Cancer Image Europe's technical standards and comply with GDPR regulations. To adhere to development guidelines, the provision of software and services must be done through containerization. Containers provide a consistent and isolated environment for deploying and running applications. Developers have to package their software and services, as described in the working document “EUCAIM software on-boarding guideline”, into container images. Containerization is required to ensure portability and security, along with clear documentation on usage, compatibility, and licensing. SPs enter the platform through a formal application process evaluated by the Cancer Image Europe Software Validator, which assesses technical, ethical, and security aspects. Once approved, software must pass integration and security tests and undergo periodic updates to maintain security and compatibility with the infrastructure.

 

Data Users (DUs) → includes researchers, data scientists, and policymakers, who want to access datasets for research and innovation purposes. To do so, they must register on the platform, accept Cancer Image Europe's Terms and Conditions, and obtain ethical committee approval if required.

Once registered, DUs can explore the Public Metadata Catalogue and submit access requests through the Negotiator component. If the requested data is already available, users can analyze it in the cloud or leverage federated processing for distributed analysis. If new datasets are needed, users must submit an observational study proposal, requiring agreements with relevant Data Holders. Cancer Image Europe also provides data pre-processing services, diagnostic software, and advanced analytical tools to facilitate data utilization for AI model development.

Users can join or establish a Research Community (RC) within the platform, composed of experts collaborating to build annotated datasets, develop AI models, and integrate them into clinical workflows.

Access Committee

From a management perspective, The Central Hub oversees governance, compliance, and sustainability, with key decision-making bodies:

• Steering Committee (SC) → Strategic decisions.
• Management Board (MB) → Operational coordination.
• Access Committee (AC) → Manages data and service access.
• Technical Board (TB), Ethical and Legal Board (ELB), Advisory Boards (AB) → Compliance and expertise.

The Access Committee, consisting of experts in medical imaging, data governance, and ethics, establishes access procedures, evaluates applications (Data Holders, Users, and Software Providers) based on scientific, legal, and technical criteria and ensures GDPR and EHDS compliance. Decisions are communicated transparently, with an appeals process available for Data Holders, Data Users, and Software Providers. 

This structured approach ensures secure, ethical, and compliant access to Cancer Image Europe resources while fostering innovation in cancer imaging research. 

Templates

This section includes the bases of the Service Level Agreement (SLA) template that will be used to regulate the integration of a local node in the Cancer Image Europe Federation. This template will need to be tailored to each specific provider, but it may help to facilitate the discussion with the provider. The final acceptance of the SLA of a specific provider will be issued by the Governing bodies. The document does not regulate the Terms of Use of the users in the platform, but the obligations of the provider to join the federation. Moreover, this document is not the compulsory template to be used but a draft to be used as a basis for developing the specific SLAs with the providers. 

The template of the SLA can be downloaded from the  https://dashboard.eucaim.cancerimage.eu/eucaim-sla-template.docx. The SLA of the UPV reference node is available in https://eucaim-node.i3m.upv.es/dataset-service/web/sla.pdf as a reference.