By connecting national networks of academic clinical research infrastructures, ECRIN was designed to bridge the fragmented organisation of European clinical research and to develop an integrated EU-wide clinical research infrastructure.

The programme started in 2004 with a diagnostic step (ECRIN-RKP, 2004-2005, funded by the FP6 Health priority) that helped identify the main bottlenecks to multinational cooperation in clinical research. This led to evidence deep and often unexpected discrepancies in national organisation and practice of clinical research (see deliverables). As a consequence, this pilot initiative led to define a strategy for the future development of a pan-European infrastructure for clinical research, based on the connection of national hubs providing services to multinational clinical studies and on the provision of services to investigators and sponsors in the conduct of multinational studies, as academic institutions often lack the capacity to fulfil the sponsor’s responsibilities in foreign countries.

In the second step (ECRIN-TWG, 2006-2008, also funded by the FP6 Health priority), procedures and guidelines to support investigators and sponsors in multinational clinical research projects in the EU were prepared by transnational working groups (see deliverables) and in particular:

• The description of national requirements for multinational clinical research in terms of ethical review, regulation, adverse event reporting, risk-based monitoring, and a corresponding set of guidance documents describing how to perform multinational clinical research projects and what the national requirements are, and the specific actions enabling projects to cross the borders.
• The description of existing data management tools, and the definition of requirements and specifications for ECRIN data centres.
• The description of existing resources in terms of training for clinical research, and the transposition of material developed by ECRIN into the preparation of yearly Summer Schools, designed to train European Correspondents.