| D1.1 | Project Handbook | PDF |
| D1.2 | Risk assessment process and management procedure | PDF |
| D2.1 | First study subject approvals package of the FS | PDF |
| D2.2 | Development of the prototype of the clinical operation data management system for the FS | confidential, internal use only |
| D2.3 | Development of the secure patient-facing online portal | confidential, internal use only |
| D2.4 | Mid-term recruitment report of the FS | not available |
| D2.5 | Development of the final version of the clinical operation data management system for the CVS | confidential, internal use only |
| D2.6 | Report on final version of the clinical operation data management system for the CVS | not available |
| D2.7 | Report on the status of posting results of the FS | confidential, internal use only |
| D3.1 | Device selection criteria and documents / processes for gathering evidence | PDF |
| D3.2 | Device and companion application usability / user-experience report, sensor data set + device selection and effort sharing, as well as application management processes for CVS | confidential, internal use only |
| D3.3 | Support centre documents and processes (especially device provisioning report) | confidential, internal use only |
| D3.4 | Report on device and application development, usage and outlook | confidential, internal use only |
| D4.1 | Definition of assessment protocol for device-specific digital endpoints | PDF |
| D4.2 | Specifications for candidate digital endpoints for fatigue, sleep disturbances and other ADL and HRQoL measures in NDD and IMID | confidential, internal use only |
| D4.3 | Performance assessment of candidate device-specific digital endpoints data - part A | confidential, internal use only |
| D4.4 | Requirements specification data analytics software package | PDF |
| D4.5 | Performance assessment of candidate device-specific digital endpoints data - part B | confidential, internal use only |
| D4.6 | Software package digital endpoints data analytics | confidential, internal use only |
| D5.1 | Data Management Plan | PDF |
| D5.2 | Specification of IDEA- FAST DMP | PDF |
| D5.3 | IDEA-FAST clinical and sensor data standards including SOPs for curation and harmonization of clinical data and measurement data | confidential, internal use only |
| D5.4 | Public version of IDEA-FAST clinical and sensor data standards | PDF |
| D5.5 | DMP prototype | confidential, internal use only |
| D5.6 | DMP V1, with harmonised clinical and sensor data loaded | confidential, internal use only |
| D5.7 | DMP V2, with blockchain-based access control and data provenance system | confidential, internal use only |
| D5.8 | DMP V3, with pipelines for integrated analysis | confidential, internal use only |
| D6.1 | First version of the CVS protocol | PDF |
| D6.2 | Finalised master documents in English for ethical/regulatory submissions, including study protocol & PIS/ ICF for the CVS | PDF |
| D6.3 | Final version of the Monitoring Plan for the CVS | confidential, internal use only |
| D6.4 | First study subject approvals package of the CVS | PDF |
| D6.5 | Mid-term recruitment report of the CVS | PDF |
| D6.6 | Report on status of posting results of the CVS | confidential, internal use only |
| D7.1 | Variability assessment of data collected during FS | confidential, internal use only |
| D7.2 | Sample size and design study for the CVS | confidential, internal use only |
| D7.3 | An AI methods toolbox for robust multi- variate time-series analysis of personal data and ML methods for heterogeneous data sources aggregation | confidential, internal use only |
| D7.4 | Library of population models with selected digital endpoints as longitudinal observations | confidential, internal use only |
| D7.5 | Data Analytic Package for the final submission for scientific advice from the EMA ± FDA | confidential, internal use only |
| D7.6 | Overview of EFPIA/ AP clinical datasets delivered to the consortium | confidential, internal use only |
| D8.1 | The model informed consent for the FS | PDF |
| D8.2 | The model informed consent for the CVS | PDF |
| D8.3 | Report on the challenges of sharing of digital device data from legal and IPR perspectives in the context of a learning health care system | confidential, internal use only |
| D8.4 | Public report on the challenges of sharing of digital device data | not available |
| D8.5 | Report on the governance of the IDEA-FAST platform | confidential, internal use only |
| D8.6 | Public report on the governance of the IDEA-FAST platform | not available |
| D9.1 | Detailed dissemination plan | PDF |
| D9.2 | Definitions of the exploitation and socio- economic evaluation framework | PDF |
| D9.3 | Final report on workshops and dissemination events | not available |
| D9.4 | Final plan on exploitation, socio- economic impact, sustainability and translation into trial use clinical practice | confidential, internal use only |
| D9.5 | Public version of final exploitation plan | not available |
