Deliverables
| Deliverable | Title | Description | Download |
|---|---|---|---|
| D1.1 | Project Handbook | The IDEA-FAST Project Handbook has two main functions. Firstly, it acts as a reference source for all Consortium members, covering many of the day-to-day activities and providing links to further information where required. Secondly, it aims to standardise various elements of the project e.g. project reports, deliverables, file naming conventions etc. through the use of agreed procedures and templates where relevant. | |
| D1.2 | Risk assessment process and management procedure | This document details the procedure within IDEA-FAST by which the project risks are identified, categorised and monitored. The most important, critical risks are already described in Annex I of the Grant Agreement. Additional risks will be identified as part of the project review and planning process. | |
| D2.1 | First study subject approvals package of the FS | The first study subject approvals package includes the final version of the feasibility study (FS) protocol, the registration number of the feasibility study as well as a short report on the ethical approval status at all four sites. | |
| 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 | to be published | |
| 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 | to be published | |
| 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 | This report presents the device selection process and materials for the IDEA-FAST project. | |
| 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 | to be published | |
| 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 | to be published | |
| 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 | This document details how the data collected, processed and generated by the IDEA-FAST project will be managed during and after the end of the project. It explains the purpose of the data collection and describes the different types of data and the associated data standards. Plans for the preservation, sharing and re-use of the data are also outlined. | |
| D5.2 | Specification of IDEA- FAST DMP | to be published | |
| 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 | to be published | |
| 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 | to be published | |
| D6.2 | Finalised master documents in English for ethical/regulatory submissions, including study protocol & PIS/ ICF for the CVS | to be published | |
| 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 | to be published | |
| D6.5 | Mid-term recruitment report of the CVS | to be published | |
| 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 | The Feasibility Study must be based on a standard model informed consent form. That model informed consent form should then be adapted by each participating centre according to its own customs (to which the IRB is used) and be made disease specific. The model is attached here. | |
| D8.2 | The model informed consent for the CVS | to be published | |
| 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 | to be published | |
| 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 | to be published | |
| D9.1 | Detailed dissemination plan | Deliverable D9.1 Detailed Dissemination Plan develops an implementable strategy with related methodologies to maximise the impact of IDEA-FAST. The strategy is built around providing key knowledge at the right time in the most appropriate format to stakeholders including the general public. | |
| D9.2 | Definitions of the exploitation and socio- economic evaluation framework | to be published | |
| D9.3 | Final report on workshops and dissemination events | to be published | |
| 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 | to be published |
Publications
coming soon
