The ECRIN integrated activity (2012-2015) is the fourth step of the ECRIN programme, funded by the FP7 Infrastructure programme.

Networking activities promote pan-European expansion, capacity building, and partnership with other world regions, and address the funding issue (WP2). ECRIN-IA develops e-services, education material to train professionals and patients associations, and communication with users, patients, citizens and policymakers (WP3). It supports the structuring and connection to ECRIN of disease-, technology-, or product-oriented investigation networks and hubs focusing on specific areas: rare diseases (WP4), medical device (WP5), and nutrition (WP6).
Transnational access activities support the cost of multinational extension of clinical trials on rare diseases, medical device and nutrition selected by the ECRIN scientific board (WP7).
Joint research activities are designed to improve the efficiency of ECRIN services, through the development of tools for risk-adapted monitoring (WP8), and the upgrade of the EORTC VISTA data management tool (WP9).

This project is designed to build a consistent organisation for clinical research in Europe, with ECRIN developing generic tools and providing generic services to multinational studies, and supporting the construction of pan-European disease-oriented networks that will in turn act as ECRIN users and provide the scientific content. Such organisation will improve Europe’s attractiveness for industry trials, boost its scientific competitiveness, and result in better healthcare for European citizens.

WP leader: Christine Kubiak, France.

• WP 2 Expansion, capacity building, partnership with other world regions, funding

Objective: To expand the capacity of ECRIN to support multinational clinical studies in Europe and globally, and to promote appropriate funding mechanisms, through pan-European expansion of ECRIN, capacity building, partnership with clinical research infrastructures in other world regions, and workshops on funding sources

WP leader: Xavier Carné, Spain, project manager: Nuria Sanz, Spain.

• WP 3 Education,e-services, communication

Objective: to update and upgrade the know-how already accumulated during the previous ECRIN steps, taking also advantage of the activities of WP4, 5, 6, and 8, to transpose it into a repository for e-services, and into education material (toolkit and train-the-trainer sessions), that will be used to develop courses for investigators, clinical research professionals, and patients associations in the national context. It will also foster communication on the challenges raised by clinical research.

WP leaders: Michael Woltz, Austria; Pierre Lafolie, Sweden and Christian Gluud, Denmark.

• WP 4 Structuring a European rare diseases clinical research network

Objective: To structure of a European hub and network for clinical research on rare diseases:
1) establishment of a hub coupled to centres and networks and connected to ECRIN and its network of European Correspondents
2) development and adaptation of common tools for clinical research on rare diseases and mapping of expertise and resources throughout Europe for the following categories: centres and networks, patient registries, regulatory and ethical expertise, harmonised outcome measures, data and sample collection, training toolkits, quality assurance and monitoring, methodology. Dissemination of this information and provision of the tools
3) use this combined infrastructure to design and conduct multinational clinical studies on rare diseases

WP leader: Ségolène Aymé, France, project manager: Nathalia Ginaldi, France.

• WP 5 Structuring a European medical device clinical research network

Objective: Structuring a European network and hub for clinical research on medical device:
1) establishment of a hub coupled to centres / networks and connected to ECRIN and its network of European Correspondents
2) development and adaptation of common tools for clinical investigation on medical device: inventory of
investigation centres, and networks, regulatory and ethical expertise, training toolkit, quality assurance and monitoring, directory of expertise and specifications for investigators and facilities for participation in clinical trials, and a methodology taskforce promoting standardised outcome measures
3) use this combined infrastructure to design and conduct multinational clinical studies on medical devices

WP leader: Edmund Neugebauer, Germany., project manager: Sunya-Lee Antoine, Germany.

• WP 6 Structuring a European network for clinical research on nutrition

Objective: To structure a European human nutrition trial centre network, coordinated with the Joint Programming Initiative on Healthy Diet for a Healthy Life (JPI HDHL) :
1) establishment of a hub coupled to centres / networks and connected to ECRIN and its network of European Correspondents
2) development and adaptation of common tools for human nutrition studies: regulatory and ethical expertise, data management tools for cohort studies, harmonisation of data and sample collection, standardisation of investigation procedures, training for investigators, quality assurance and monitoring, and a methodology taskforce
3) use this combined infrastructure to design and conduct multinational human nutrition interventional studies

WP leader: Martine Laville, France, project manager: Yvonne Masson, France.

• WP 7 Free services to multinational clinical trials

Objective: to facilitate the conduct of multinational studies, this work package will cover the cost of services for multinational implementation of clinical studies having obtained a public or charity funding in the coordinating country, including the cost of the data management.
To be consistent with the structuring actions described in WP4, 5 and 6, this transnational access will target clinical studies on rare diseases, medical devices and nutrition strengthening research in these fields, contributing to structure investigation networks.
The ECRIN scientific board will organise a competitive call (M12,) to select the supported projects.

WP leader: Silvio Garattini, Italy.

• WP 8 Development of a risk-adapted monitoring toolbox

Objective: To identify, assess and validate potentially efficient tools for the implementation of risk-based monitoring strategies.

WP leader: Valérie Journot, France.

• WP 9 Adaptation of the VISTA data management tool

Objective: To provide a professional, state-of-the-art and efficient Clinical Data Management Tool for multinational clinical trials to the ECRIN user community and for non-commercial clinical research.The tool will be an adaptation and re-programming of the existing system ‘VISTA Trials’, previously developed and routinely applied by EORTC in many clinical trials, and will be based on international standards and ECRIN requirements. Maintenance and support of the tool will be provided by EORTC in cooperation with ECRIN beyond the end of the project. EORTC and ECRIN will guarantee non-profit fees for the use of the tool and services.Provision of this tool will help overcome fragmentation and heterogeneity of the clinical trial data management status and will allow cost-efficient, sustainable and high-quality data management, especially in non-commercial clinical trials in Europe.

WP leaders: Stéphane Lejeune, Belgium and Christian Ohmann, Germany.

The Network Committee is composed of one senior representative from each scientific participant (the national coordinator). It gives strategic direction and has at least one face to face meeting per year. Chair: Anna Chioti Luxemburg.  Co-chair: Christian Ohmann Germany

The Co-ordination Board is composed of the 9 WP leaders and project coordination. It coordinates the daily activities of work packages.

The External Advisory Board is composed of stakeholders and users (EU commission, EMA, CTFG, IMI, EFPIA, EuropaBio, ESF, OECD, EDCTP, European Society of Cardiology, NHI/NCI, EATG, Treat- NMD, Eucomed, JPI on nutrition). It provides strategic input for the development of ECRIN.

The Scientific Board is in charge of the scientific and methodological assessment of the clinical research projects submitted for access to the ECRIN services. It is composed of 3 ECRIN members and 4 external members. For the purpose of the ECRIN-IA WP7 activities, the Board is supported by  three experts representing the rare diseases, medical devices, and nutrition communities and two patient representatives. Chair Silvio Garattini, Italy.

The Ethical Advisory Board supervises the overall ethical dimension of the project.  It is composed of 2 ECRIN members and 3 external members.

The Project Coordination Team, located at INSERM headquarters in Paris, is composed of the coordinator and project managers.  It is in charge of the daily management of the project.  It acts as the ECRIN contact point for users, for the EU Commission, and for external and international partners. The Coordinator is Jacques Demotes-Mainard, France.

The European Correspondents (one per country, hosted in the national hub) act as a local relay of ECRIN activities for the development of services, for the quality assurance unit and for the provision of support to pan-European clinical research projects. The European Correspondents are the single contact point for sponsors and investigators in their respective countries.