Deliverables

DeliverableTitleDescriptionDownload
D1.1Project HandbookThe 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.PDF
D1.2Risk assessment process and management procedureThis 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.PDF
D2.1First study subject approvals package of the FSThe 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.PDF
D2.2Development of the prototype of the clinical operation data management system for the FSconfidential, internal use only
D2.3Development of the secure patient-facing online portalconfidential, internal use only
D2.4Mid-term recruitment report of the FSto be published
D2.5Development of the final version of the clinical operation data management system for the CVSconfidential, internal use only
D2.6Report on final version of the clinical operation data management system for the CVSto be published
D2.7"Report on the status of posting results" of the FSconfidential, internal use only
D3.1Device selection criteria and documents / processes for gathering evidenceThis report presents the device selection process and materials for the IDEA-FAST project.PDF
D3.2Device and companion application usability / user-experience report, sensor data set + device selection and effort sharing, as well as application management processes for CVSconfidential, internal use only
D3.3Support centre documents and processes (especially device provisioning report)confidential, internal use only
D3.4Report on device and application development, usage and outlookconfidential, internal use only
D4.1Definition of assessment protocol for device-specific digital endpointsto be published
D4.2Specifications for candidate digital endpoints for fatigue, sleep disturbances and other ADL and HRQoL measures in NDD and IMIDconfidential, internal use only
D4.3Performance assessment of candidate device-specific digital endpoints data - part Aconfidential, internal use only
D4.4Requirements specification data analytics software packageto be published
D4.5Performance assessment of candidate device-specific digital endpoints data - part Bconfidential, internal use only
D4.6Software package digital endpoints data analyticsconfidential, internal use only
D5.1Data Management PlanThis 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.PDF
D5.2Specification of IDEA- FAST DMPto be published
D5.3IDEA-FAST clinical and sensor data standards including SOPs for curation and harmonization of clinical data and measurement dataconfidential, internal use only
D5.4Public version of IDEA-FAST clinical and sensor data standardsto be published
D5.5DMP prototypeconfidential, internal use only
D5.6DMP V1, with harmonised clinical and sensor data loadedconfidential, internal use only
D5.7DMP V2, with blockchain-based access control and data provenance systemconfidential, internal use only
D5.8DMP V3, with pipelines for integrated analysisconfidential, internal use only
D6.1First version of the CVS protocolto be published
D6.2Finalised master documents in English for ethical/regulatory submissions, including study protocol & PIS/ ICF for the CVSto be published
D6.3Final version of the Monitoring Plan for the CVSconfidential, internal use only
D6.4First study subject approvals package of the CVSto be published
D6.5Mid-term recruitment report of the CVSto be published
D6.6"Report on status of posting results" of the CVSconfidential, internal use only
D7.1Variability assessment of data collected during FSconfidential, internal use only
D7.2Sample size and design study for the CVSconfidential, internal use only
D7.3An AI methods toolbox for robust multi- variate time-series analysis of personal data and ML methods for heterogeneous data sources aggregationconfidential, internal use only
D7.4Library of population models with selected digital endpoints as longitudinal observationsconfidential, internal use only
D7.5Data Analytic Package for the final submission for scientific advice from the EMA ± FDAconfidential, internal use only
D7.6Overview of EFPIA/ AP clinical datasets delivered to the consortiumconfidential, internal use only
D8.1The model informed consent for the FSThe 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.PDF
D8.2The model informed consent for the CVSto be published
D8.3Report on the challenges of sharing of digital device data from legal and IPR perspectives in the context of a learning health care systemconfidential, internal use only
D8.4Public report on the challenges of sharing of digital device datato be published
D8.5Report on the governance of the IDEA-FAST platformconfidential, internal use only
D8.6Public report on the governance of the IDEA-FAST platformto be published
D9.1Detailed dissemination planDeliverable 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.PDF
D9.2Definitions of the exploitation and socio- economic evaluation frameworkto be published
D9.3Final report on workshops and dissemination eventsto be published
D9.4Final plan on exploitation, socio- economic impact, sustainability and translation into trial use clinical practiceconfidential, internal use only
D9.5Public version of final exploitation planto be published

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