European Clinical Research Infrastructures Network

The European Clinical Research Infrastructures Network (ECRIN) was established in 2004 with funding from Sixth Framework Programme as a reciprocal knowledge programme, to connect national networks of clinical research infrastructures throughout the European Union.

The national participants work in a network together with the European Forum for Good Clinical Practice^[1]. Six European countries participate in ECRIN : (Sweden, Denmark, Germany, France, Spain and Italy) and the have a transatlantic link with Canada. These collectively represent 112 medical centres and hospitals that conduct in the region of 1,500 clinical studies. If ECRIN succeeds in helping to create a Europe-wide network of centres sufficient scale will evolve to facilitate EU standards in clinical research and appropriate training.

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Objectives

ECRIN intends to meet the expectations of the EU and the pharmaceutical industry through a harmonisation process, ensuring adequate quality standards through audit procedures and an ability to conducts cross-border projects that comply with good clinical practice.

• Improve the quality of clinical research through the compatibility of procedures, tools and practices.
• Support industry and academic multinational clinical studies in Europe.
• Promote specialty or disease-specific networks, working multinationally and using cohorts and registries of patients; fostering enrolment to same.

Removing Bottlenecks

A ten-point set of initiatives is being developed across participating member countries to stramline clinical research:

• Compatible structuring of centres, partnerships
• Sponsors and funding
• Ethics and informed consent
• Legislation, regulation and insurance
• Adverse event reporting
• Methodology, data management and monitoring
• Quality assurance, standard operating procedure and audits
• Communication with participants, investigators and sponsors
• Transparency and clinical trial registries
• Education and careers

References

1. ^ http://www.efgcp.be/

See also

• Harmonization in clinical trials
• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
• European Medicines Agency (EMEA, EU)
• EUDRANET
• EudraVigilance
• Quality assurance
• Standing operating procedure