Work Package 1

D 1.1 VALIDATE trustworthy AI framework and manual

D 1.2 Z-inspection process result report

D 1.3 Report of qualitative interview study

D 1.4 Audit results, framework and manual update at M18

D 1.5 Audit results, framework and manual update at M36

D 1.6 SOP guideline on trustworthy AI development of an AI-based clinical decision support system

Work Package 2

D 2.1 Models and report on Iteration 1, transition from TRL 3 to 4

D 2.2 Models and report on Iteration 2, transition from TRL 4 to 5

D 2.3 Models and report on Iteration 3, transition from TRL 5 to 6

D 2.4 Final report about continuous model performance and data distribution monitoring during clinical validation

D 2.5 SOP guideline on model development, validation and lifecycle management of AI models for prognostic tools

Work Package 3

D 3.1 Research data management Plan (DMP)

D 3.2 Integrated requirements report covering technical and user requirements

D 3.3 Design Prototype

D 3.4 Integrated Demonstrator with Health Information System

D 3.5 Final report on usability and quality of service of clinical demonstrator and updated Data Management Plan

Work Package 4

D 4.1 Study initiation package

D 4.2 Electronic patient recorded outcome framework (NORA) adaptation

D 4.3 Completion of pre-clinical study (retrospective)

D 4.4 Midterm recruitment report

D 4.5 Completion of clinical study (prospective) and report on the status of posting results in a repository

D 4.6 Report of the standard treatment scenario based on current care pathways and SoC operating procedures

D 4.7 Aggregated per site monthly reports from NORA platform of patients' recruitment and outcome

D 4.8 Recommendations for the use of AI in SOPs and changes in stroke pathways

Work Package 5

D 5.1 Detailed Plan for exploitation activities

D 5.2 Cost-effectiveness and budget-impact framework

D 5.3 Regulatory Pathway to Market for AI-based Medical Devices

D 5.4 Comparative cost-effectiveness analysis between SOC and VALIDATE prognostic tool impact

D 5.5 Budget impact report for adopting VALIDATE into clinical practice

D 5.6 Roadmap towards MD certification of VALIDATE solutions

D 5.7 Final commercialisation and exploitation plan, business plan

Work Package 6

D 6.1 Steering committee report of the clinical study, SAFE and patients from clinical centres meetings

D 6.2 Report on communication and information through NORA

D 6.3 Decision dashboard for physicians and patient application concept for information, health assessment

Work Package 7

D 7.1 Project management plan

D 7.2 Communication and dissemination strategy

D 7.3 Plan for Managing Knowledge and Intellectual Property

D 7.4 Final communication and dissemination report