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ECRIN-ERIC is the abbreviation for European Clinical Research Infrastructure Network, and is a public, non-profit organisation that links scientific partners and networks across Europe to facilitate multinational clinical research. ECRIN provides sponsors and investigators with advice, management services and tools to overcome hurdles to multinational clinical trials and enhance collaboration. ERIC is the abbreviation for ‘European Research Infrastructure Consortium’, a legal framework created by the European Union.

HISTORY OF ECRIN-ERIC
ECRIN was created in 2004 to support primary academic sponsors and investigators across Europe to overcome the barriers to multinational clinical research. ECRIN’s first European project (ECRIN-RKP, 2004-05 ) focused on strategy, the second (ECRIN-TWG, 2006-08 ) on tools, and the third (ECRIN-PPI, 2008-12 ) on infrastructure development. Before having a legal status of ERIC and receiving sustainable support from its member and observer countries, ECRIN was developed and matured through a series of five EU-funded projects: FP6, FP7, and Horizon 2020 ).

2004-2005: Identify bottlenecks to multinational collaboration and define strategy
From 2004 to 2005, ECRIN led its first project, ECRIN Reciprocal Knowledge Programme or ECRIN-RKP (funded by European Union Framework Programme 6, "Societal challenges” health sub-programme), involving six countries. ECRIN-RKP aimed to determine bottlenecks to multinational collaboration in academic clinical studies. The ECRIN-RKP pilot project led to the definition of a strategy for the creation of a pan-European infrastructure for clinical research.

2006-2008: Develop tools and ESFRI roadmap
In 2006, ECRIN started its second project, ECRIN Transnational Working Group or ECRIN-TWG (also funded by European Union Framework Programme 6, involving 10 countries. The aim was to develop procedures and guidelines for investigators and sponsors involved in multinational clinical research in Europe. The project involved analysis of existing data management tools, training resources, and national regulatory and ethical requirements, leading to recommendations and guidance documents. As part of the project, ECRIN began to develop common monitoring tools to enhance collaboration. It also started to establish networks of academic clinical trials units across Europe. Another milestone during this time was the inclusion of ECRIN, in 2006, on the European Strategy Forum on Research Infrastructures (ESFRI) roadmap.

2008-2011: Build a sustainable infrastructure and initial services
ECRIN’s third project, ECRIN Preparatory Phase for Infrastructure or ECRIN PPI (funded by European Union Framework Programme 7, was launched in 2008 with 14 countries. The goal was to define the necessary organisational and legal structure for ECRIN to support the establishment and implementation of multinational clinical trials in Europe. In short, it aimed to develop ECRIN’s business plan and legal status. The project validated ECRIN’s proposed organisation, and as part of ECRIN PPI, ECRIN began to provide services to multinational clinical studies in 2009. It also established its Scientific Board and started data centre certification.

2012-2017: Build capacity in rare diseases, medical devices and nutrition and ERIC status
In 2012, ECRIN embarked on its fourth project, ECRIN Integrating Activity or ECRIN-IA (also funded by European Union Framework Programme 7), involving 23 countries and covering three main areas of expertise: rare diseases, medical devices and nutrition. In parallel, ECRIN continued to develop its services, providing various forms of support to European clinical trials. It established standards for the acceptance of projects applying for such services.

Late 2013, ECRIN was awarded the status of European Research Infrastructure Consortium (ERIC) by the European Commission – a legal status to facilitate the establishment and operation of research bodies of European interest. This was a key development as it ensured ECRIN’s financial sustainability.

2016: ESFRI landmark status
In 2016, ECRIN was designated an 'ESFRI Landmark' on the ESFRI Roadmap 2016. ESFRI Landmarks are research infrastructures that were implemented (or started implementation) before 2015 and are now considered ‘pan-European hubs of scientific excellence, generating new ideas and pushing the boundaries of science and technology’.

ORGANISATION & FUNDING
ECRIN is a 'distributed research infrastructure', a distinct organisation that connects research facilities at multiple sites in countries across Europe and provides services for top-level clinical research. As a pan-European research infrastructure, ECRIN has successfully developed itself as a unique, sustainably-funded, not-for-profit intergovernmental organisation, based on country membership.

Members & Observers
ECRIN has nine member countries: Czech Republic, France, Germany, Hungary, Ireland, Italy, Norway, Portugal and Spain, and three observer countries: Poland, Slovakia, and Switzerland. The member countries have access to the full range of ECRIN services and collaboration opportunities. The observer status lasts for a maximum of three years.

Collaboration with countries is achieved through ECRIN's organisation involving the Paris-based core team, the European correspondents (EuCos) based in each member or observer country, and the national scientific partners (usually a network of clinical research units, CTUs). European Correspondents oversee the implementation of ECRIN’s work in their respective countries, managing the trial portfolio and coordinating with the national scientific partner and other relevant stakeholders. The core team, based in Paris, develops ECRIN’s strategy, common tools and procedures, and contributes to 'infrastructure development' projects. The national scientific partners manage trials in-country and host the European Correspondents.

Governance
According to the statutes, the governance is by the Assembly of Members, the Steering Committee, and the Director General.

- The Assembly of Members (AoM) is composed of a representative from the government of each member or observer country.

- The Steering Committee oversees activities and provides advice on budget, work plan and scientific/technical matters. It is composed of the Chair and Vice Chair of both the AoM and the Network Committee, and the Director General.

Additional advisory bodies are:

- The Network Committee represents the scientific partners and has an advisory role for the AoM and Director General.

- The ECRIN Advisory Board is composed of individuals representing diverse areas related to clinical research, both in Europe and internationally. Members provide input and recommendations to the AoM on all matters related to the activities of the infrastructure and its further development.

Funding
ECRIN is funded by the contributions of its member and observer countries. These funds are primarily dedicated to supporting the organisation and developing its core competencies to enable the provision of operational support to multinational trials. Costs incurred by specific projects aimed at developing new tools and procedures, or multinational clinical trials where ECRIN provides trial management services, are funded by grants from European funding bodies such as Horizon 2020 [6], Innovative Medicines Initiative, IMI 2 and services provided to industry sponsors, for example.

MULTINATIONAL CLINICAL TRIALS
Multinational clinical studies are studies conducted in more than one country, and are considered necessary to understand best how to address global medical needs.

Advantages of multinational clinical trials
Multinational clinical trials have many advantages as they provide greater access to patients, facilities and medical expertise. Also they enhance methodological standards and enable the sharing of costs, tools and procedures. And multinational clinical trials increase the potential for broad implementation of research outcomes, and prevent duplication of research. ECRIN provides tools and services to overcome the above challenges by offering researchers support to prepare and implement multinational trials.

International Clinical Trials Day
In 2005, ECRIN launched International Clinical Trials Day (ICTD) to commemorate the day when James Lind started his famous clinical trial on scurvy in 1747, May 20th, and laid the foundation for modern clinical research. Celebrated every year on or around May 20th, ICTD is an opportunity for research organisations, clinical research professionals, and the public to acknowledge the achievements that result from clinical research and to discuss various trial topics. ECRIN’s annual celebration of ICTD brings together European and international stakeholders. Given its success, the conference has been replicated by some of ECRIN’s member/observer countries, who have now introduced their own national/international ICTD celebrations.

SERVICES, SUPPORT, TOOLS AND PROJECTS
The main activity of ECRIN-ERIC is the provision of support for the management of multinational clinical trials, which is primarily provided during the implementation, but also during the preparation and the protocol evaluation. In order to do so ECRIN offers several services, support, tools and projects.

- Trial preparation : Guiding investigators/sponsors, project coordinators and other stakeholders through the different aspects of multinational trial organisation and advicing on funding, site mapping and participant recruitment, selection of clinical trial units, regulatory and ethical requirements, insurance requirements, and costs.

- Protocol review : In the phase immediately preceding trial implementation, ECRIN provides scientific & methodological evaluation, and logistical assessment.

- Trial management : ECRIN provides trial management across borders to overcome obstacles that occur due to working in different country systems. During project implementation, ECRIN offers investigators and project coordinators trial management services such as submissions to competent authorities & ethics committees, insurance support, monitoring, adverse event reporting, data management, recommendations for health product and biosample management.

- Quality : The ECRIN quality management system (QMS) is fit-for-purpose and has been adapted to its distributed infrastructure. It follows a risk and process-based approach, which is founded on the recommendations of the ISO 9001:2015 standard and the International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP E6 (R2)). ECRIN is currently pursuing certification with ISO 9001:2015, the international standard specifying requirements for quality management systems.

- Data Certification Standard: The ECRIN Data Centre Certification programme identifies non-commercial clinical trials units (CTUs) in Europe that have demonstrated they can provide safe, secure, compliant and efficient management of clinical research data.

ECRIN-ERIC provides also several tools for multinational clinical trials, among others:

- Risk based monitoring toolbox : The Risk-Based Monitoring Toolbox provides information on tools available for risk assessment, monitoring and study conduct, the institutions where they are used, and other relevant details such as links and user feedback.

- Clinical Research Metadata Repository : The Clinical Research Metadata Repository helps scientific researchers to find documents and data linked to a clinical research study, and to obtain information on the accessibility of those results.

- ECRIN-Campus : A central resource for information about clinical trial regulatory and ethical requirements covering 22 European countries and multiple study types such as clinical drug trials, clinical investigations of medical devices, combination drug-device studies and nutritional studies. This project is currently under development.

ALLIANCE
In July 2019 ECRIN-ERIC, BBMRI-ERIC and EATRIS-ERIC signed an agreement to build a long-term sustainable collaboration strategy. The agreement lays the ground for facilitating user access to pan-European medical research infrastructures and supporting the development of tools, joint services and common approaches on quality, standards and advocacy. As a result, the agreement will empower BBMRI, EATRIS and ECRIN to provide services to the biomedical community and to support a more cost-effective research and development process. The Alliance goes currently under the working title AMRI, and aims to facilitate the use of scientific services, expertise and tools by academia and industry for the seamless translation of their scientific discoveries into new treatments and solutions for patients.