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| # Number | Title | Description | Download |
|---|---|---|---|
| D1.1 | Project Handbook | ||
| D1.2 | Risk assessment process and management procedure | ||
| D2.1 | First study subject approvals package of the FS | ||
| 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 | ||
| 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 | not available | |
| 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 | not available | |
| 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 | ||
| D5.2 | Specification of IDEA- FAST DMP | not available | |
| 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 | not available | |
| 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 | not available | |
| D6.2 | Finalised master documents in English for ethical/regulatory submissions, including study protocol & PIS/ ICF for the CVS | not available | |
| 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 | not available | |
| D6.5 | Mid-term recruitment report of the CVS | not available | |
| 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 | ||
| D8.2 | The model informed consent for the CVS | not available | |
| 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 | ||
| D9.2 | Definitions of the exploitation and socio- economic evaluation framework | not available | |
| 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 | |
coming soon
IDEA FAST presentation
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 853981. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA and PARKINSON’S DISEASE SOCIETY OF THE UNITED KINGDOM LBG.
