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This report provides an update to the second version of the ELIXIR-CONVERGE Project Handbook, shown in Deliverable D6.3. The project handbook follows the Open PM² best practices to provide the board members and the project participants with a clear definition of their roles and responsibilities as well as the relevant processes and assets the project will use to ensure contractual commitments in the Grant Agreement are delivered on time and within the scope and budget and with the expected level of quality.&nbsp

This report provides an overview of the development of the GDI Project Handbook. The Project Handbook follows the Open PM² best practices to provide the board members and the project participants with a clear definition of their roles and responsibilities, as well as the relevant processes and assets the project will use, to ensure contractual commitments in the Grant Agreement are delivered on time and within the scope and budget, and with the expected level of quality., GDI project receives funding from the European Union's Digital Europe Programme under grant agreement number 101081813

The aim of the 1+MG initiative with coordination and support from the Beyond 1 Million Genomes (B1MG) project is to recommend technologies, methodologies, and governance models for the 1+MG signatories (member states) that support cross-border data access to both genetic and phenotypic data. Prospective users are researchers and clinicians who facilitate the development of personalised medicine across the European Union. The 1+MG data infrastructure needs to be defined to ensure data managed within the federated network are compliant with the European and national legislation on data protection, security, and ELSI principles agreed in 1+MG. At the same time the aim is to maximise the Findability, Accessibility, Interoperability and Reusability of the 1+MG data, according to FAIR principles. In this deliverable a Proof of Concept (PoC) was built using existing standards, applications, and services to demonstrate cross border data access for two 1+MG use cases; rare disease and cancer. The intention is to create a technical infrastructure baseline and advancement for the next iteration of implementation data protection principles according to the GDPR, and agreed in discussion with B1MG WP2. The work is not complete, and will continue during 2022-2027 in the European Genomics Data Infrastructure project. As these data are envisioned to be located in distributed nodes hosted in different 1+MG signatory countries, these nodes must be interoperable with each other. Ideally, compatibility with other infrastructures or data spaces in Europe can be maximised as well, while considering the timelines to achieve the ambition of the 1+MG initiative, and hence the user stories described here do not necessarily correspond to the user stories required to conform with the 1+MG data governance. Global standards were chosen, where possible, within the PoC to maximise interoperability between the PoC, the 1+MG data infrastructure (as provided by organisations such as CSC in Finland), and with other European-level data infrastructures and data spaces. In 1+MG the applications or services utilised within the PoC to construct the infrastructure service functionalities and the data analysis workflows are strongly recommended to be open-source to enable security review, as well as have permissive software licence allowing redistribution and modifications. The Genome Phenome Analysis Platform, which was used to demonstrate the ‘processing’ functionality via visualisation for the rare disease use-case, does not yet comply with this overall recommendation, but the underlying infrastructure does not restrict the applications that can be used by the use of common open source standards to facilitate communication between components. Applications and services, where possible, are utilised by users in service production environments across organisations providing existing (research) data infrastructures or resources, again to maximise interoperability and leverage existing or previous developments. Additionally, all applications needed to provide the five functionalities of data reception, data discovery, access management, storage and interfaces, and processing (data analysis) are in active development within their respective communities. Input into the PoC was taken from both WP/WG2 and WP3 / WGs 3 & 4, as well as other related projects such as TEHDAS, CINECA, EJP-RD, as well as the European Health Data Space. The PoC demonstrates cross border data access for secondary use by a researcher for both use cases as demonstrated by a video uploaded to Youtube and a presentation to the 1+MG Special Group meeting in November 2022 (Link).

B1MG Project Milestone:M6.5 Project impact and monitoring indicators presented to OG - update

B1MG Milestone M6.4 Project impact and monitoring indicators presented to OG

The 1+MG Use Case WGs leads and experts have contributed to the direction of the B1MG WPs activities since the beginning of the project. Their contributions are fundamental to determining the resulting infrastructure needs as well as analysing the final solutions and how they support the various scenarios. This deliverable builds on previous informal and formal work, as well as contributions from other project and initiative activities: 1+MG use cases working group meetings Workshop to identify health care scenarios across 1+MG WGs Workshop to identify research scenarios across 1+MG WGs B1MG Operational group meetings (1+MG WGs & B1MG WP) Stakeholders forum outcomes 1+MG Group meetings This deliverable gives the first formal snapshot of the requirements of the 1+MG use case WGs and their current implementation state, which has been collected as part of the B1MG project directly. This inventory of met and unmet needs of the use case WGs will subsequently be used to drive infrastructure development and prioritise future 1+MG infrastructure actions. Successful implementation of the requirements will be evaluated by 1+MG WGs, ensuring that the final 1+MG infrastructure is fit for purpose. WP7 must still debate the implementation of the recently obtained EC recommendations to collect user requirements using particular software tracking techniques. The outcomes of those discussions will be incorporated into the future version of this deliverable.

Presentation -Introduction to the B1MG project and 1+MG initiative

B1MG First Stakeholder meeting - 16th October 2020 - agenda and slides

Presentation -Introduction to the B1MG project and 1+MG initiative

Growth of omics disciplines has significantly increased the researchers' demand for support in the field of data management. It follows that long term sustainability of existing data management services and platforms is of critical importance to the research community. The ELIXIR-CONVERGE Task 1.3-Business model aims at investigating long-term sustainability strategies for supporting the provision of said data management/data stewardship services. In order to achieve this goal, the authors reviewed existing business models that were currently implemented by the ELIXIR Nodes. Data collection was performed by means of on-line surveys and interviews, investigating how DM/DS services are delivered and how they are financially supported. The current investigation was performed at different time points along the implementation of the ELIXIR-CONVERGE action, allowing the authors to sketch an analysis of the delivered services, and their financial sustainability in a two years time frame. The investigation revealed how in almost all the Nodes, the delivery of data management services depends on public subsidies, usually by means of a mix of institutional, national and European Union/European Commission funded projects. Likewise, the current work highlighted how Nodes are exploring new sustainability strategies and models where part of the costs are recovered from final users. Considering the gradient of public subsidisation and user/customer contribution, the authors of the current report characterised the implemented sustainability strategies under three (plus one) business models: Free, Freemium, Pay per use (Pay per use +). Although a growing number of Nodes are moving towards exploring and implementing sustainable business models, our investigation highlights how in most cases the resulting strategies can be considered only experimental. In several instances transactions are only virtual and cost recovery often never happens in full. The main outcome of the effort presented in the current document is the definition of a portfolio of fact sheets describing all the alternative funding strategies other than the full public subsidisation implemented by the Nodes: the Business Model Catalog.

The Project Handbook provides a complete overview of the management and administrative procedures and principles to ensure efficient execution of the BY-COVID project, thus contributing to the production of high-quality project results. It contains all relevant planning information that the consortium partners will use as a framework for delivery during the course of the project, therefore, it is the point of reference for all consortium partners and stakeholders.

This report provides an overview of the development of the second version of the B1MG Project Handbook. The project handbook follows the Open PM² best practices to provide the board members and the project participants with a clear definition of their roles and responsibilities as well as the relevant processes and assets the project will use to ensure contractual commitments in the Grant Agreement are delivered on time and within the scope and budget and with the expected level of quality.&nbsp

This report provides an update to the initial version of the ELIXIR-CONVERGE Project Handbook, shown in Deliverable D6.1. The project handbook follows the Open PM² best practices to provide the board members and the project participants with a clear definition of their roles and responsibilities as well as the relevant processes and assets the project will use to ensure contractual commitments in the Grant Agreement are delivered on time and within the scope and budget and with the expected level of quality.&nbsp

A roadmap is required to communicate the plans for development of the infrastructure to provide secure cross border data access to genetic and phenotypic data to interested stakeholders. The roadmap is a live document, with the initial deliverable being version1, which will evolve as the requirements of more use cases and updates to technology and standards are taken into account. The main aim of the roadmap presented here is to define the timelines to provide a proof of concept demonstrator of secure cross border data access, describe the technologies required todevelop such a demonstrator, and to detail the work that has gone into determining the roadmap and requirement for the proof of concept demonstrator. The roadmap also outlines how it is expected that the work carried out towards the initial proof of concept will support the developing roadmap for 2022 and beyond, as the proof of concept evolves from a demonstrator with synthetic data to a production system accessing real genetic and phenotypic data.

The National Mirror Groups (NMG) are a national reflection of the working groups set up by the 1+MG Initiative. Due to the differences among countries, both in terms of research and innovation and health systems governance and in terms of approaches with respect to the 1+MG initiative, mirror groups are set up in different configurations. Furthermore, some of these member states are still in the process of establishing them. For this reason, it is necessary to map the configurations of the NMGs in the different countries to identify the commonalities on the NMG configurations and if these configurations can be correlated with peculiarities of the different National Health Systems across Europe and with the implementation of the initiative at the national level. This mapping will also help us to know how and to what extent NMGs connect with their national initiatives. To this aim, the following actions have been carried out: The development of an initial factsheet (see section 10.1) called ‘National Mirror Groups at a Glance’ to help countries clarify the mission, role, tasks and structure of NMGs in the initiative for the time being. A survey (see section 10.2) has been circulated among the participating Member States and the Observer Countries of the initiative and was analysed the different existing mirror groups assessing its structure, composition, governance, and operating modes and if they were correlated with their national structures. Bilateral meetings have been held with some countries to gain knowledge about the structure and operation of NMGs in those countries and its implementation at the national level. After analyzing the results, it has been found that in most of the countries (10 of 19)he WG1 representative is the main figure that coordinates the NMGs that only 22.22% of the countries (4 of 18) consider that their NMGs are ‘Operational’, and just over half of the countries consider that there is engagement between their NMGs and the initiative. Besides, the composition of the NMGs is quite heterogeneous among countries. Regarding the representation of stakeholders, it should be noted that most of the countries have a high representation of the research and university communities and not so much of the clinics. To achieve the goals regarding NMGs set up in the roadmap of the initiative, it would be recommendable that at least 75% of the countries have their NMGs operational by the end of 2021, that all NMGs have a high engagement with the initiative and they be aligned with national initiatives and countries feed their NMG with stakeholders related with patient organisations, industry and clinical communities. This data has enabled us to set up some guiding principles and identify a first set of best practices for the good set-up, running and coordination of mirror groups.

The ELIXIR Project Monitoring Tool (ELIXIR PM Tool) has been developed in the scope of the ELIXIR-CONVERGE WP6 to democratise the access to project information such as project folders, deliverables, milestones, actions, events, TCs, and use of resources. It intends to generate and distribute periodic status reports per all beneficiaries, LTPs and WPs. BioData.pt | ELIXIR-PORTUGAL (ELIXIR-PT) encased the first pilot to adopt the ELIXIR PM Tool for its internal projects.

The B1MG project Communication Strategy provides guidance and resources to support the effective communication of the project. Its objective is to act as a reference point for all aspects of B1MG communications, providing guidelines to partners internally, and harmonising communications to users externally. Through the document we present and discuss: Communication channels, branding, communication assets, evaluation, and communication guidance., B1MG has received funding from the European Union's Horizon 2020 Research and Innovation programme under grant agreement No 951724

B1MG Stakeholder Coordination Group Portal goes live https://b1mg-project.eu/news-events/, B1MG has received funding from the European Union's Horizon 2020 Research and Innovation programme under grant agreement No 951724

This report provides an overview of the development of the initial version of the B1MG Project Handbook. The project handbook follows the Open PM2 best practices to provide the board members and the project participants with a clear definition of their roles and responsibilities as well as the relevant processes and assets the project will use to ensure contractual commitments in the Grant Agreement are delivered on time and within the scope and budget and with the expected level of quality., Funding: Beyond One Million Genomes (B1MG) European Commission Horizon 2020 Grant No. 951724

B1MG project Kick-off meeting held. Governing Board, Scientific & Ethical Advisory Board and Operational Groups in place., B1MG has received funding from the European Union's Horizon 2020 Research and Innovation programme under grant agreement No 951724

ELIXIR-CONVERGE is a project funded by the European Commission to help standardise life science data management across Europe. To achieve this standardisation, the project will develop a data management toolkit for life scientists. The toolkit will help ensure more research data is in the public domain, which will give scientists access to more data. This will allow them to discover new insights into the challenges facing society, such as food security and health in old age, and help stimulate innovation in biomedicine and biotechnology. This report provides an overview of the development of the initial version of the ELIXIR-CONVERGE Project Handbook. The project handbook follows the Open PM² best practices to provide the board members and the project participants with a clear definition of their roles and responsibilities as well as the relevant processes and assets the project will use to ensure contractual commitments in the Grant Agreement are delivered on time and within the scope and budget and with the expected level of quality., This project has received funding from the European Union's Horizon 2020 Research and Innovation programme under grant agreement No 871075 .