Deliverables
Procedure for assessing risks and monitoring mitigation actions
First version of the CVS protocolWe will collate information concerning national regulatory requirements via ECRIN national CTUs for the Clinical Validation Study protocol preparation
Mid-term recruitment report of the FSReport on the numbers of each type of patient recruited at the mid-point of the feasibility study.
Public report on the challenges of sharing of digital device dataPublic version of D83
Requirements specification data analytics software packageThe different requirements for data analytics software will be defined
Data Management PlanInitial version of Data Management Plan (to be updated throughout the project as necessary). The Data Management Plan will also address the following: 1. The consortium members must confirm that they have appointed Data Protection Officers (DPOs) and the contact details of the relevant DPO are made available to all data subjects involved in the research. For the consortium members not required to appoint a DPO under the General Data Protection Regulation a detailed data protection policy for the project must be elaborated and kept on file. It must be provided to IMI JU upon request. 2. For the research involving profiling, the applicants must provide, prior to the start of the relevant research activity, an explanation on how the data subjects will be informed of the existence of the profiling, its possible consequences and how their fundamental rights will be safeguarded. 3. For the processing of previously collected personal data, an explicit confirmation that the applicants have lawful basis for the data processing and that the appropriate technical and organisational measures are in place to safeguard the rights of the data subjects must be provided. Relevant authorisations must be obtained and kept on file. The documents must be provided to IMI JU upon request.
Specification of IDEA-FAST DMPSpecification of a secure, fit-for-purpose, adaptable data management platform based on the output of the eTRIKS project.
The model informed consent for the CVSBuilding upon experiences in other projects model Informed Consent Forms will be developed which will be used as the basis for data transfers within IDEAFAST
Detailed dissemination planPlans will be drawn up to regularly highlight the project developments at relevant conferences, in peer-reviewed journals and at dedicated workshops organised by the consortium. All journal publications will be open access. The dissemination plans, which will be continuously reviewed and updated, will identify key project related publications, which will be earmarked for “gold” open access. Dissemination will also be assured through the establishment and maintenance of a project website from the start of the project, with links to the participating researchers, clinicians and institutions.
Public version of IDEA-FAST clinical and sensor data standardsPublic version of D53
Report on final version of the clinical operation data management system for the CVSPublic version of report relating to D25
Definition of assessment protocol for device-specific digital endpointsFormulation of performance measures, evaluation criteria and protocols.
Definitions of the exploitation and socio-economic evaluation frameworkWe will conduct a socioeconomic impact assessment based on a costbenefit assessment CBA framework
The model informed consent for the FSBuilding upon experiences in other projects, model Informed Consent Forms will be developed which will be used as the basis for data transfers within IDEA-FAST.
First study subject approvals package of the CVSUKSH and lead CTU together with ECRIN will prepare all the study documentation pack for the relevant national submissions to ethics and regulators as necessary
First study subject approvals package of the FSThe CKI-TF will prepare all study documentation and support the translation of the document to the local language from English. This will be used to gain the necessary approvals.
Mid-term recruitment report of the CVSReport on the numbers of each type of patient recruited at the midpoint of the Clinical Validation Study
Project HandbookQuick reference guide for all IDEA-FAST project participants
Finalised master documents in English for ethical/regulatory submissions, including study protocol & PIS/ICF for the CVSThe final protocol and informed consent forms will be submitted to all appropriate regulatory authorities ethics committees and other appropriate authorities as applicable per country law
Device selection criteria and documents / processes for gathering evidenceWe will use unified testing protocols, feedback forms and data collection mechanisms that will enable a centralized body of the evidence required to inform the device and software/application selection process. The selection process will combine: general information on the devices (e.g. technical specifications), existing data, and laboratory and situated (“in-the-wild”) testing with expert and non-expert users to inform a decision based on: a) the ability of the devices to efficiently capture reliable sensor data, and b) the usability and user experience when using the devices.
Publications
Author(s):
Luan Chen, Xujun Ma, Meenakshi Chatterjee, Juha M Kortelainen, Teemu Ahmaniemi, Walter Maetzler, Pei Wang, Daqing Zhang
Published in:
Proceedings of the 44th Annual International Conference of the IEEE Engineering in Medicine & Biology Society (EMBC), 2022, ISBN 978-1-7281-2783-5
Publisher:
IEEE
DOI:
10.1109/embc48229.2022.9870923
Author(s):
Luis F. Gomez; Aythami Morales; Juan R. Orozco-Arroyave; Roberto Daza; Julian Fierrez
Published in:
Proceedings of the IEEE/CVF Conference on Computer Vision and Pattern Recognition Workshops (CVPRW), 2021, ISSN 2160-7508
Publisher:
IEEE
DOI:
10.1109/cvprw53098.2021.00172
Author(s):
André Rodrigues; André R.B. Santos; Kyle Montague; Hugo Nicolau; Tiago Guerreiro
Published in:
Adjunct Proceedings of the 2021 ACM International Joint Conference on Pervasive and Ubiquitous Computing and Proceedings of the 2021 ACM International Symposium on Wearable Computers (UbiComp '21), Issue September 2021, 2021, ISBN 9781450384612
Publisher:
Association for Computing Machinery
DOI:
10.1145/3460418.3482872
Author(s):
Alfonso Ortega; Julian Fierrez; Aythami Morales; Zilong Wang; Tony Ribeiro
Published in:
2021 IEEE Winter Conference on Applications of Computer Vision Workshops (WACVW), Issue 5th - 9th January 2021, 2021
Publisher:
IEEE
DOI:
10.1109/wacvw52041.2021.00013
Author(s):
Diogo Branco, Patrick Carrington, Silvia Del Din, Afsaneh Doryab, Hristijan Gjoreski, Tiago Guerreiro, Roisin McNaney, Kyle Montague, Alisha Pradhan, André Rodrigues, Julio Vega
Published in:
Adjunct Proceedings of the 2021 ACM International Joint Conference on Pervasive and Ubiquitous Computing and Proceedings of the 2021 ACM International Symposium on Wearable Computers (UbiComp '21), 2021, ISSN 978-1-4503-8461
Publisher:
ACM
DOI:
10.1145/3460418.3479271
Author(s):
Jay Rainey, David Verweij, Colin Dodds, Johanna Graeber, Farzaneh Farhadi, Ridita Ali, Viana Zhang, Christopher N. Bull, Jan David Smeddinck
Published in:
Adjunct Proceedings of the 2021 ACM International Joint Conference on Pervasive and Ubiquitous Computing and Proceedings of the 2021 ACM International Symposium on Wearable Computers (UbiComp '21), Issue September 2021, 2021
Publisher:
Association for Computing Machinery
DOI:
10.1145/3460418.3479371
Author(s):
Roberto Daza; Aythami Morales; Julian Fierrez; Ruben Tolosana
Published in:
ICMI Companion, Issue October 2020, 2020, ISBN 9781450380027
Publisher:
Association for Computing Machinery
DOI:
10.1145/3395035.3425257
Author(s):
André Rodrigues, Hugo Nicolau, André Santos, Diogo Branco, Jay Rainey, David Verweij, Jan David Smeddinck, Kyle Montague, Tiago Guerreiro
Published in:
Proceedings of the 2022 CHI Conference on Human Factors in Computing Systems, 2022, ISBN 978-1-4503-9157-3
Publisher:
ACM
DOI:
10.1145/3491102.3501908
Author(s):
Alejandro Acien, Aythami Morales, Ruben Vera-Rodriguez, Julian Fierrez
Published in:
Proceedings of the IEEE 44th Annual Computers, Software, and Applications Conference (COMPSAC), 2020
Publisher:
IEEE
DOI:
10.1109/compsac48688.2020.00-81
Author(s):
Alfonso Ortega; Julian Fierrez; Aythami Morales; Zilong Wang; Marina de la Cruz; César Luis Alonso; Tony Ribeiro
Published in:
Computers, Issue 10/11, 2021, ISSN 2073-431X
Publisher:
MDPI
DOI:
10.3390/computers10110154
Author(s):
Evert-Ben Van Veen; Martin Boeckhout; Irene Schlünder; Jan Willem Boiten; Vasco Dias
Published in:
Open Research Europe, Issue 4, 2022, ISSN 2732-5121
Publisher:
European Commission
DOI:
10.12688/openreseurope.14825.1
Author(s):
Alejandro Acien; Aythami Morales; John V. Monaco; Ruben Vera-Rodriguez; Julian Fierrez
Published in:
IEEE Transactions on Biometrics, Behavior, and Identity Science, Issue 4(1), 2022, ISSN 2637-6407
Publisher:
IEEE
DOI:
10.1109/tbiom.2021.3112540
Author(s):
Bing Zhai, Ignacio Perez-Pozuelo, Emma A. D. Clifton, Joao Palotti, Yu Guan
Published in:
Proceedings of the ACM on Interactive, Mobile, Wearable and Ubiquitous Technologies, Issue 4/2, 2020, Page(s) 1-33, ISSN 2474-9567
Publisher:
Association for Computing Machinery
DOI:
10.1145/3397325
Author(s):
Marcos Faundez-Zanuy, Julian Fierrez, Miguel A. Ferrer, Moises Diaz, Ruben Tolosana, Réjean Plamondon
Published in:
Cognitive Computation, Issue 12, 2020, ISSN 1866-9956
Publisher:
Springer Verlag
DOI:
10.1007/s12559-020-09755-z
Author(s):
Walter Maetzler, Lynn Rochester, Roongroj Bhidayasiri, Alberto J. Espay, Alvaro Sánchez‐Ferro, Janet M.T. Uem
Published in:
Movement Disorders, Issue 36/1, 2021, Page(s) 76-82, ISSN 0885-3185
Publisher:
John Wiley & Sons Inc.
DOI:
10.1002/mds.28377
Author(s):
Truong, Nguyen; Sun, Kai; Wang, Siyao; Guitton, Florian; Guo, Yike
Published in:
Computers & Security, Issue 110, 2021, ISSN 0167-4048
Publisher:
Pergamon Press Ltd.
DOI:
10.1016/j.cose.2021.102402
Author(s):
Truong, Nguyen; Lee, Gyu Myoung; Sun, Kai; Guitton, Florian; Guo, Yike
Published in:
Future Generation Computer Systems, Issue 124, 2021, ISSN 0167-739X
Publisher:
Elsevier BV
DOI:
10.1016/j.future.2021.05.025
Author(s):
Rana Zia Ur Rehman, Yu Guan, Jian Qing Shi, Lisa Alcock, Alison J. Yarnall, Lynn Rochester and Silvia Del Din
Published in:
Frontiers in Aging Neuroscience, Issue 14, 2022, ISSN 1663-4365
Publisher:
Frontiers Research Foundation
DOI:
10.3389/fnagi.2022.808518
Author(s):
Emmi, Antikainen; Haneen, Njoum; Jennifer, Kudelka; Diogo, Branco; Rana Zia Ur, Rehman; Victoria, Macrae; Kristen, Davies; Hanna, Hildesheim; Kirsten, Emmert; Ralf, Reilmann; C, Janneke van der Woude; Walter, Maetzler; Wan-Fai, Ng; Patricio, O'Donnell; Geert, Van Gassen; Frédéric, Baribaud; Ioannis, Pandis; Nikolay V, Manyakov; Mark, van Gils; Teemu, Ahmaniemi; Meenakshi, Chatterjee
Published in:
Frontiers in Physiology, Issue 13, 2022, ISSN 1664-042X
Publisher:
Frontiers Research Foundation
DOI:
10.3389/fphys.2022.968185
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