Work Packages

Project Management & Coordination

Lead: Charité – Universitätsmedizin Berlin & AstraZeneca

WP01 sets the strategic direction of the project and ensures that activities across all work packages, institutions and countries stay aligned. The work package establishes the project's decision-making bodies, defines standards for administrative and financial compliance, maintains the risk register, and manages the project's relationship with the IHI JU — including periodic reporting, audits and contractual obligations.

Key Activities

• ✦ Consortium governance and stakeholder communication
• ✦ Financial management and IHI reporting
• ✦ Risk register and mitigation planning
• ✦ Cross-work package alignment and synergy management

People-Centred Innovation & Interestholder Engagement

Lead: Medizinische Hochschule Brandenburg

WP02 ensures that GUIDE-AI fits the people who will use it. It analyses the interests, needs and concerns of patients, clinicians and health system actors, identifies the barriers to guideline-directed medical therapy and maps the patient journey to guide user-centred design.

Key Activities

• ✦ Interestholder mapping
• ✦ Patient journey mapping
• ✦ Process evaluation and iterative user feedback
• ✦ Patient-Reported Outcome and Experience Measures (PROMs, PREMs) monitoring

GUIDE-AI Navigator Development

Lead: University of Pavia

This work package curates and represents the guideline knowledge sources, develops the backend system and engineers the patient- and clinician-facing components.

Key Activities

• ✦ Acquisition of knowledge sources and knowledge representation
• ✦ GUIDE-AI backend system development
• ✦ Integration of the backend with user-facing components
• ✦ LLM prompt engineering and explainable output personalization

Benchmarking Performance & Robustness

Lead: Ecodynamics & Charité – Universitätsmedizin Berlin

WP04 tests the navigators using a diverse retrospective dataset of patient cases drawn from different countries and languages, including explainability and multilingual usability. A structured red-teaming effort probes the system against adversarial attacks and assesses bias. The work package also examines whether the approach generalizes to other diseases.

Key Activities

• ✦ Development of a benchmarking framework
• ✦ Comparative performance evaluation
• ✦ Red teaming and bias assessment
• ✦ Generalisation and scalability to other diseases

Real-World Validation & Multicentric Insights

Lead: Charité – Universitätsmedizin Berlin & IRCCS Maugeri di Pavia

WP05 serves as the clinical and operational backbone of the evaluation study. It prepares the study protocol and informed consent materials, secures regulatory and ethics approvals, registers the trial, and coordinates recruitment, data collection and safety monitoring across sites in Germany and Italy.

Key Activities

• ✦ Protocol development including patient engagement
• ✦ Site selection and trial coordination
• ✦ Recruitment, data collection, quality and safety monitoring
• ✦ Analysis and reporting

Navigating Risks, Ethics & Compliance

Lead: AstraZeneca

WP06 ensures GUIDE-AI meets high standards of ethical integrity, legal and regulatory compliance, and proactive risk governance.

Key Activities

• ✦ Risk management framework and live risk register
• ✦ Ethical oversight and compliance
• ✦ Regulatory compliance strategy
• ✦ Policy alignment