1. Introduction

1.1. Purpose of the handbook

This handbook is designed to guide Data Holders through the onboarding process for sharing or transferring data to the EUCAIM infrastructure. It outlines the roles, responsibilities, legal and technical requirements, and procedural steps to ensure compliance and facilitate smooth integration into the EUCAIM Federation.

The primary objectives of this Handbook are to:

• Help institutions understand the requirements for contributing data to EUCAIM.

• Explain the onboarding steps, documentation, tools, and other resources available.

• Ensure alignment with EUCAIM’s Data Federation Framework (DFF) and FAIR (Findable, Accessible, Interoperable, Reusable) principles.

• Align with the methodological and data standards (such as Health DCAT-AP) in the context of the European Health Data Space (EHDS).

• Support legal, ethical, and technical compliance during data contribution.

It is intended for use by the technical teams of a data holder and anybody involved in the preparation, validation, or transfer of health data and imaging resources to EUCAIM.

1.2. Overview of EUCAIM Data Federation, Data Holder’s Onboarding Workflow

The EUCAIM Data Federation is a decentralized infrastructure enabling the secure and privacy-preserving sharing of cancer imaging and clinical datasets across Europe. It includes both Reference Nodes and Federated Nodes, allowing Data Holders to either transfer anonymized datasets to EUCAIM’s secure reference nodes or maintain data locally while supporting federated queries and processing.

Before you start, pre-onboarding workflow:

1. If you are not an EUCAIM’s partner, and you are joining as a Data Holder, please make sure you complete the Expression of Interest so we can have your organisation registered: EUCAIM Dashboard

2. Register into the EUCAIM’s Dashboard with a Life Science AAI (LS-AAI) account. Please follow these guidelines: AAI in EUCAIM

3. If you are not in the mailing list of Data Holders or do you want to make any subscription changes please send a helpdesk ticket in the “First line support” category. If you do not have an account yet, you can use the helpdesk link https://dashboard.eucaim.cancerimage.eu/helpdesk.

4. Kindly ensure that you read the entire Handbook carefully. This will also help you identify the appropriate channels for any questions, depending on the subject matter.

5. Please find also here a glossary with the most commonly used terms in the field of Health Data Research: EUCAIM Glossary

The summarized onboarding workflow for Data Holders includes:

1. Initial assessment: retrieving all the Data Holders’ information through the:

• Tier’s Maturity Level Questionnaire (must be completed by all Data Holders): TIER Maturity Level Questionnaire This will allow us to assess the readiness and compliance of datasets provided by data holders categorizing them into three Tiers:

  • Tier 1: The datasets hosted by the federated node are registered in the central catalogue. Users can explore the metadata of the datasets registered in EUCAIM’s platform.

  • Tier 2: The data of the federated node is searchable through its local searching service, which is queried by the federated search system. The users can explore the actual number of studies fulfilling the search criteria defined by the user.

  • Tier 3: The federated node has a materialisation component that makes the data available to the federated processing, according to EUCAIM’s model. The user will be able to run processing actions on the actual data, if the access to them is granted.

• Data Warehouse Maturity Questionnaire (must be completed just by the hospitals): Data Warehouse Maturity Questionnaire This will allow us to determine its preparedness and maturity to be part of a federated European data infrastructure for research by categorizing the centers into three CLUSTERS (1, 2 and 3).

1. Selection of integration method: data transfer to a Reference Node or local Federated Node setup.

2. Legal/Ethical/Technical compliance documentation:

• GDPR-compliant documentation to be reviewed and approved by the institutional ethics committee.

• DTA/DSA signature + other documentation, please go to section 3.2 Legal Documents of this Handbook.

• Technical requirements: Technical_requirements_Data_Holders

1. Imaging and data preparation according to the EUCAIM Common Data Model and Hyperontology: https://eucaim.gitbook.io/eucaim-common-data-model/

2. Data transfer to the reference node vs data sharing by setting up a federated node.

3. Participation in monitoring, validation and quality assurance activities.

Each step is supported by tools, documentation, and expert teams from EUCAIM, ensuring Data Holders receive technical, legal, and procedural guidance throughout the process.

1.3. Roles and responsibilities of Data Holders

Data Holders in EUCAIM are organizations that contribute with medical imaging, clinical and annotation datasets to the federated infrastructure.

Their responsibilities include:

• Ensuring compliance with legal, ethical and technical requirements.

• Providing datasets in acceptable formats.

• Conducting proper anonymization and privacy risk assessments.

• Maintaining documentation and evidence of data provenance, ethical approval and GDPR compliance.

• Collaborating with EUCAIM technical teams during onboarding and integration.

• Participating in ongoing monitoring, updates, and audits of the shared data.