Schematic illustration of the relationship between the IDEA-FAST WPs

All Work Packages

1. Project Management and Oversight

WP1 incorporates overall Project Coordination, Project Management, Financial Management and Risk Management for the project. This includes compilation of reports and other deliverables for submission to IMI, development of strategies and long-term project plans …

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2. Clinical Knowledge and Insight

WP2 provides the critical clinical knowledge and patient insight needed to deliver all project objectives. The WP2 leadership will coordinate a Clinical Knowledge and Insight Task Force (CKI-TF) that will include …

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3. Digital Device and Technology

WP3 is responsible for optimization of the selected digital devices to the project needs, facilitating the implementation and use of digital hardware devices and accompanying software (or applications) in the clinical trials …

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4. Device-specific Data Analytics and Performance Assessment

WP4 handles the analysis of data from the different digital devices and technologies used in IDEA-FAST. It involves quality checking of the collected device-specific data …

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5. Data Management

The IDEA-FAST datasets are expected to be heterogeneous, large-scale and highly complex. WP5 will establish the state-of-the-art data management environment to address the needs of data standardisation, integration, sharing, analysis and archive for the project …

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6. Clinical Study Organisation & Management

WP6 is responsible for the operational management of the clinical validation study. Partner ECRIN will work closely with the Sponsor and the lead CTU (both UKSH), the clinical leads, the CKI-TF, the technology partners …

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7. Statistical Inference Design and Learning

WP7 (final fatigue/sleep endpoints) together with WP4 (deriving intermediate predictors) is responsible for the analysis of the extant datasets as well as the data from the FS and the CVS. It will perform …

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8. Data Protection, Ethics and Legal Challenges

WP8 provides the critical input to issues arise from the project in relation to the areas of data privacy/protection, legal, ethical and other relevant regulations, and ensure compliance. Patient data within IDEA-FAST is only accessible for …

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9. Dissemination, Exploitation & Sustainability

To ensure maximal impact, WP9 activities will run concurrently with the activities of WP2-7 as part of an iterative process, harnessing the substantial clinical and regulatory expertise present within IDEA-FAST …

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