Leistungen
This deliverable will firstly contain the agreed upon scientific aims and hypotheses tested through specific proposed analyses during the project
Participant recruitment, Pre-existing RWD access, Prospective RWD acquisition and secure storage -v2D83D87 reported in 5 deliverables each one being an update of the previous one aim to a reflect the number of participants enrolled prospectively on a biannual basis until the end of the study and verify ethical RWD acquisition following informed consent and IRB approval b document the amount of RWD reflective of our CoBraD Protocol acquired from preexisting databases on a biannual basis within the study c reflect the actual RWD acquired and stored on a biannual basis in our shared and secure database in an anonymised manner D85 D87 will also document the pilots operation and execution and also evaluate the platform from the users perspective They will also present lessons learnt during the project constituting methodological adoption guidelines for the utilisation of the platform
Business and Exploitation Plan - v1This deliverable will deal with an early version of the Business and Exploitation Plan
Communication & Dissemination PlanThis deliverable will deal with the MESCoBrad Communication Dissemination Plan with a view to increase the impact of MESCoBrad ensuring the widest possible visibility of the project promoting its activities and maximising its potential outreach
System requirements & architectureBased on the scenarios setup in WP3 this deliverable will present the functional and nonfunctional system requirements and the overall solution architecture that will be the baseline for the development WPs The architecture will describe in detail the integration logic and interfaces between the involved tools and services produced by WP5 and WP6 as well as the interaction of the components
The CoBraD ethical and regulatory frameworkIdentification of the applicable legal and ethical regulations applicable to the CoBraD project Special attention will be given to EU law on personal data protection the GDPR and any other applicable regulations or guidance at EU and MS level applicable ethical standards in EU research projects within the CoBraD subjectmatter and and other relevant rules and regulations The following shall constitute particular points of attention 1 Any special derogations pertaining to the rights of data subjects or the processing of genetic biometric andor health data have been established under the national legislation of the EU country where the research takes place 2 Justification for the processing of sensitive personal data 3 The data minimization principle 4 International data transfers and confirmation that such transfers are in accordance with Chapter V of the General Data Protection Regulation 2016679 5 In the event of personal data transferred from a nonEU country to the EU or another third state confirmation that such transfers comply with the laws of the country in which the data was collected
MES-CoBraD Validation FrameworkThis deliverable is related to the documentation of the evaluation framework and validation methodology defining the various practices for obtaining feedback from endusers and including a set of testcases to be executed by the endusers
Assessment of the CoBraD PUCs against ethical and legal standardsThis report will release a first assessment about the compliance of CoBrad Pilot Use Cases PUC with the essential regulatory ethical and legal framework identified under T21 Precisely the document will report a how the consortium ensures respect for research or study participants and for human dignity and fair distribution of the benefits and burden of research and how consortium will protect the values rights and interests of the research participants particularly with reference to vulnerable groups children disable people b how the consortium ensures GDPR compliance concerning to research which involves processing of personal data regardless of the method used eg interviews questionnaires direct online retrieval etc c whether the PUCs have obtained the necessary opinionsapprovals by local and national ethics committees andor competent authorities for the research with humans performed in the pilot studies first study subject approvals package
Establishment of the External Advisory BoardThis deliverable will document the selection procedure and the presentation of an External Advisory Board which will serve to provide an unbiased and ongoing perspective on the developed protocols and their implementation ensuring the project reaches its goals The board will cover all the medical technological community and ethical aspects and it will be consisted by members with professional expertise in these subjects
Report on the registration of the StudiesThis deliverable is related to the registration of the study on the European Union Clinical Trials Register EUCTR administered by the European Medicines Agency EMA We will register the multicenter prospective cohort study with the inclusion and exclusion criteria as well as the primary objectives and methodology of the study
Project Manual - CoBraD RWD, Updated MES-CoBraD Protocols and Quality and Quantity (Q&Q) Evaluation - v1This deliverable will Provide the updated specific characteristics of the populations tobestudied and the specific data from these populations tobeacquired The purpose is to have an agreement between research participating organisations and community stakeholders on the utility and acceptability of RWD to be used in future analyses by respecting medical ethics values autonomy beneficence nonmaleficence justice and containing the approvals of Pilot organisations IRBsdefine the final updated protocols to be pursued as part of data acquisition sharing and information dissemination after receiving input from stakeholders and oversight by the External Advisory Board The purpose is to have an agreed upon protocol on the acquisition and handling of RWD that will be the basis for the threeyear research and innovation plandefine the critical elements all data should have to be considered of high acceptable quality as well as the amount of data necessary to achieve the overall project objectives
Project Manual - CoBraD RWD, Updated MES-CoBraD Protocols and Quality and Quantity (Q&Q) Evaluation - v2This deliverable will be an update of D31 as well as provide the highlevel methodology of the project that will guide the rest of the projects activities based on usage scenarios as defined with the support of the pilot organisations
Scientific Aims, Testable Hypotheses and Scientifically Sound, Evidence-based Recommendations for the Assessment and Management of CoBraD in real-world practice - v2D43D46 will contain the updates of D42 in the following months of project duration Furthermore it will include all submitted scientific publications resulting in scientifically sound evidencebased recommendations informing professional organisations policy healthcare and insurance stakeholders on changes that can improve assessment and management of CoBraD in realworld practice D46 will be the final outcome of WP4 providing the summary of all scientific publications that resulted in the project concluding based on them to the final Guidelines for the Professional Diagnostic Practice or Safety and Efficacy of RealWorld Medical Therapies
Stakeholder engagement strategyThis deliverable represents a comprehensive sound KPIdriven strategy that the project will follow throught its duration in order to identify and engage with relevant stakeholders The strategy will be used as a roadmap of engagement activities per stakeholder category and at multistakeholder level and will be revisited throughout the project
Participant recruitment, Pre-existing RWD access, Prospective RWD acquisition and secure storage -v1D83D87 reported in 5 deliverables each one being an update of the previous one aim to a reflect the number of participants enrolled prospectively on a biannual basis until the end of the study and verify ethical RWD acquisition following informed consent and IRB approval b document the amount of RWD reflective of our CoBraD Protocol acquired from preexisting databases on a biannual basis within the study c reflect the actual RWD acquired and stored on a biannual basis in our shared and secure database in an anonymised manner D85 D87 will also document the pilots operation and execution and also evaluate the platform from the users perspective They will also present lessons learnt during the project constituting methodological adoption guidelines for the utilisation of the platform
This deliverable will consists of the MESCoBrad project web site graphical and textual design and implementation
Promotional and informational materialThis deliverable will deal with the graphical and textual design of promotional and informational material
Online materialsThis deliverable will deal with the online material
This will be a production ready and first release of the algorithm expert system, including all the optimizations and additional functionalities from the main prototype.
Data integration, harmonisation, sharing and security - v1In this deliverable the integration and harmonisation process from heterogeneous data sources will be widely analysed and the adopted solutions and standards will be presented in detail. Moreover, the security aspect, its relative criticality and the adopted countermeasures will be discussed. Finally, the improvement provided to the MES CoBraD project by the introduction of sharing capabilities and the availability of a front-end for the management of data will be presented.
Veröffentlichungen
Autoren:
George Stravodimos
Veröffentlicht in:
2022
Herausgeber:
The MES-CoBraD Project
DOI:
10.5281/zenodo.6473320
Autoren:
LIBER; HOLISTIC
Veröffentlicht in:
2022
Herausgeber:
LIBER
DOI:
10.5281/zenodo.7180887
Autoren:
KCL
Veröffentlicht in:
2022
Herausgeber:
The MES-CoBraD Project
DOI:
10.5281/zenodo.6473259
Autoren:
Engineering - Ingegneria Informatica S.p.A.
Veröffentlicht in:
2022
Herausgeber:
The MES-CoBraD Project
DOI:
10.5281/zenodo.6473275
Autoren:
Stravodimos, George
Veröffentlicht in:
2021
Herausgeber:
The MES-CoBraD Project
DOI:
10.5281/zenodo.5155585
Autoren:
Stravodimos, George
Veröffentlicht in:
2021
Herausgeber:
The MES-CoBraD Project
DOI:
10.5281/zenodo.5547122
Autoren:
IR-HSCSP
Veröffentlicht in:
2022
Herausgeber:
The MES-CoBraD Project
DOI:
10.5281/zenodo.6473289
Autoren:
Keret, Ophir
Veröffentlicht in:
2021
Herausgeber:
The MES-CoBraD Project
DOI:
10.5281/zenodo.5106495
Autoren:
KCL
Veröffentlicht in:
2021
Herausgeber:
The MES-CoBraD Project
DOI:
10.5281/zenodo.5547100
Autoren:
RMC
Veröffentlicht in:
2021
Herausgeber:
The MES-CoBraD Project
DOI:
10.5281/zenodo.5544020
Autoren:
Montal, Victor
Veröffentlicht in:
2021
Herausgeber:
The MES-CoBraD Project
DOI:
10.5281/zenodo.5547113
Autoren:
Sergi Vazquez Maymir
Veröffentlicht in:
2022
Herausgeber:
The MES-CoBraD Project
DOI:
10.5281/zenodo.6473241
Autoren:
Konstantinos Alexakis; Panagiotis Kapsalis; Zoi Mylona; Georgios Kormpakis; Evangelos Karakolis; Christos Ntanos; Dimitris Askounis
Veröffentlicht in:
International Conference on Information, Intelligence, Systems & Applications (IISA), Ausgabe 13, 2022, Seite(n) 1-6, ISBN 978-1-6654-6390-4
Herausgeber:
IEEE
DOI:
10.1109/iisa56318.2022.9904384
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